<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03287089</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00022622</org_study_id>
    <nct_id>NCT03287089</nct_id>
  </id_info>
  <brief_title>Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery</brief_title>
  <acronym>NAUTICA</acronym>
  <official_title>Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery (NAUTICA): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the&#xD;
      efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for&#xD;
      the prevention of catheter-associated urinary tract infections in patients with postoperative&#xD;
      short-term catheterization following pelvic reconstructive surgery and/or urinary&#xD;
      incontinence surgery.&#xD;
&#xD;
      Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail&#xD;
      their post-operative voiding trial will be included in the study. Upon successfully passing&#xD;
      and in-office voiding trial at the time of catheter removal, they will be randomized to&#xD;
      either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily&#xD;
      for 5 days following catheter removal. The primary outcome will be the treatment of&#xD;
      clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes&#xD;
      include adverse events associated with nitrofurantoin use and medication compliance.&#xD;
&#xD;
      Primary and secondary outcomes will be evaluated with Student t test and chi squared or&#xD;
      Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to&#xD;
      nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05, we&#xD;
      should recruit a total of 164 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary tract infections (UTI) are the most common hospital-acquired infections, accounting&#xD;
      for nearly 30% of cases of nosocomial infections and affecting nearly 1 million people per&#xD;
      year.&#xD;
&#xD;
      Following pelvic reconstructive and urinary incontinence surgery, UTIs are one of the most&#xD;
      common complications with a risk between 8.9%-34%. The baseline risk of UTI associated with&#xD;
      pelvic floor surgery ranges between 5-35%, increasing greatly with catheterization.&#xD;
&#xD;
      Postoperative voiding dysfunction and incomplete bladder emptying is common following pelvic&#xD;
      reconstructive and incontinence surgeries, with incidence ranging from 2.5 % to 31%. As a&#xD;
      result, these women may have additional catheterization for a short period of time, which&#xD;
      increases the risk of UTI. There is a 15-20% risk of developing a postoperative UTI with&#xD;
      short-term catheterization, even if the catheter remains in place for merely 24 hours. The&#xD;
      risk of UTI increases 5-10% each day the catheter is left in place.&#xD;
&#xD;
      Numerous studies have been conducted to evaluate different prophylactic antibiotic regimens&#xD;
      to help decrease the rate of postoperative catheter-associated UTIs. Many of these studies&#xD;
      have shown precedent for the use of antibiotic prophylaxis.&#xD;
&#xD;
      Nitrofurantoin has been evaluated as a prophylactic regimen for use during short-term&#xD;
      catheterization. These studies had favorable results, decreasing the incidence of UTI&#xD;
      postoperatively.&#xD;
&#xD;
      Although there are a few studies showing favorable results for the use of prophylactic&#xD;
      nitrofurantoin during catheterization after pelvic surgery, the optimal timing of antibiotic&#xD;
      administration and length of dosing regimen is not well defined. The American Urological&#xD;
      Association (AUA) recommends empiric antibiotic treatment at the time of external urinary&#xD;
      catheter removal in patients with risk factors, such as tobacco use, advanced age, and&#xD;
      anatomic abnormalities of the urinary tract. The AUA Panel does cite that bacteriuria in the&#xD;
      setting of noninfectious urinary tract disease is a risk factor for bacteremia, and, thus,&#xD;
      prophylactic antibiotic treatment at time the of catheter removal may be indicated. The AUA&#xD;
      does recommend empiric antibiotic treatment at the removal of an external urinary catheter in&#xD;
      patients with risk factors. However, there is no standardization concerning the type of&#xD;
      antibiotic to be used or treatment duration.&#xD;
&#xD;
      Although there are a few studies showing favorable results for use of nitrofurantoin during&#xD;
      catheterization after pelvic surgery, there are no clearly defined recommendations regarding&#xD;
      its use for urinary tract infection prevention after catheter removal. Therefore, the&#xD;
      objective of our study is to examine the effects of administration of nitrofurantoin therapy&#xD;
      at the time of Foley catheter removal for the prevention of catheter-associated UTI in&#xD;
      patients undergoing POP and/or urinary incontinence surgery.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter&#xD;
      discontinuation for the prevention of catheter-associated urinary tract infections in&#xD;
      patients with postoperative short-term catheterization following pelvic reconstructive&#xD;
      surgery. The primary outcome will be the treatment of clinically suspected and/or&#xD;
      culture-proven UTI within 30 days of surgery.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      To evaluate adverse outcomes related to study medications in each group and to evaluate&#xD;
      medication compliance&#xD;
&#xD;
      Null Hypothesis:&#xD;
&#xD;
      The null hypothesis is that the administration of nitrofurantoin will not reduce the rate of&#xD;
      UTI compared with placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>UTI</measure>
    <time_frame>within 30 days of surgery</time_frame>
    <description>Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>within 30 days of surgery</time_frame>
    <description>Number of participants with an adverse event only related to study drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Compliance</measure>
    <time_frame>within 30 days of surgery</time_frame>
    <description>Compliance assessed by use of a medication diary during treatment period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Catheter-Associated Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>Nitrofurantoin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Receives twice daily matching placebo for 5 days following catheter removal</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitrofurantoin 100 MG</intervention_name>
    <description>Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days</description>
    <arm_group_label>Nitrofurantoin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18&#xD;
&#xD;
          -  Creatinine clearance greater than 30 ml/min&#xD;
&#xD;
          -  Failed postoperative hospital voiding trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  History of glucose-6-phosphate dehydrogenase deficiency&#xD;
&#xD;
          -  History of renal insufficiency, renal transplant, or nephropathy&#xD;
&#xD;
          -  Allergy to nitrofurantoin&#xD;
&#xD;
          -  History of recurrent UTI (defined as greater than two culture-proven infections in six&#xD;
             months or three infections in one year)&#xD;
&#xD;
          -  Urinary Tract Infection (UTI) within 14 days one month of surgery&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Urinary tract infection while Foley catheter is in place&#xD;
&#xD;
          -  On antibiotic therapy for other non-urological reasons&#xD;
&#xD;
          -  Sustained intraoperative bladder injury requiring prolonged catheterization greater&#xD;
             than 5 days&#xD;
&#xD;
          -  Undergoing mesh excision from within the bladder, fistula repair, cystotomy repair,&#xD;
             urethral diverticulectomy, sacral neuromodulation, urethral surgery, or any other&#xD;
             procedure requiring prolonged catheterization and bladder decompression&#xD;
&#xD;
          -  Placement of a suprapubic catheter&#xD;
&#xD;
          -  Participants that request intermittent self-catheterization&#xD;
&#xD;
          -  Neurologic conditions affecting urinary tract system and normal voiding mechanisms&#xD;
&#xD;
          -  History of hepatic impairment due to prior nitrofurantoin use&#xD;
&#xD;
          -  Inability to provide consent/decisionally impaired&#xD;
&#xD;
          -  More than two in-office voiding trials&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dina Bastawros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>van der Wall E, Verkooyen RP, Mintjes-de Groot J, Oostinga J, van Dijk A, Hustinx WN, Verbrugh HA. Prophylactic ciprofloxacin for catheter-associated urinary-tract infection. Lancet. 1992 Apr 18;339(8799):946-51. doi: 10.1016/0140-6736(92)91529-h.</citation>
    <PMID>1348797</PMID>
  </reference>
  <reference>
    <citation>Ghezzi F, Serati M, Cromi A, Uccella S, Salvatore S, Bolis P. Prophylactic single-dose prulifloxacin for catheter-associated urinary tract infection after tension-free vaginal tape procedure. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jul;18(7):753-7. doi: 10.1007/s00192-006-0233-4. Epub 2006 Nov 21.</citation>
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  </reference>
  <reference>
    <citation>Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024. Erratum In: Obstet Gynecol. 2014 Mar;123(3):669.</citation>
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    <PMID>23611930</PMID>
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  <reference>
    <citation>Sutkin G, Alperin M, Meyn L, Wiesenfeld HC, Ellison R, Zyczynski HM. Symptomatic urinary tract infections after surgery for prolapse and/or incontinence. Int Urogynecol J. 2010 Aug;21(8):955-61. doi: 10.1007/s00192-010-1137-x. Epub 2010 Mar 31.</citation>
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    <citation>Dieter AA, Amundsen CL, Visco AG, Siddiqui NY. Treatment for urinary tract infection after midurethral sling: a retrospective study comparing patients who receive short-term postoperative catheterization and patients who pass a void trial on the day of surgery. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):175-8. doi: 10.1097/SPV.0b013e3182544e03.</citation>
    <PMID>22543772</PMID>
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  <reference>
    <citation>Vigil HR, Mallick R, Nitti VW, Lavallee LT, Breau RH, Hickling DR. Risk Factors for Urinary Tract Infection following Mid Urethral Sling Surgery. J Urol. 2017 May;197(5):1268-1273. doi: 10.1016/j.juro.2016.12.093. Epub 2016 Dec 27.</citation>
    <PMID>28034608</PMID>
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    <citation>Schiotz HA, Guttu K. Value of urinary prophylaxis with methenamine in gynecologic surgery. Acta Obstet Gynecol Scand. 2002 Aug;81(8):743-6. doi: 10.1080/j.1600-0412.2002.810810.x.</citation>
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    <citation>Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.</citation>
    <PMID>17517855</PMID>
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  <reference>
    <citation>Sutkin G, Lowder JL, Smith KJ. Prophylactic antibiotics to prevent urinary tract infection during clean intermittent self-catheterization (CISC) for management of voiding dysfunction after prolapse and incontinence surgery: a decision analysis. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Aug;20(8):933-8. doi: 10.1007/s00192-009-0885-y. Epub 2009 Apr 10.</citation>
    <PMID>19582384</PMID>
  </reference>
  <reference>
    <citation>Falagas ME, Athanasiou S, Iavazzo C, Tokas T, Antsaklis A. Urinary tract infections after pelvic floor gynecological surgery: prevalence and effect of antimicrobial prophylaxis. A systematic review. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1165-72. doi: 10.1007/s00192-008-0584-0. Epub 2008 Apr 10.</citation>
    <PMID>18401538</PMID>
  </reference>
  <reference>
    <citation>Rogers RG, Kammerer-Doak D, Olsen A, Thompson PK, Walters MD, Lukacz ES, Qualls C. A randomized, double-blind, placebo-controlled comparison of the effect of nitrofurantoin monohydrate macrocrystals on the development of urinary tract infections after surgery for pelvic organ prolapse and/or stress urinary incontinence with suprapubic catheterization. Am J Obstet Gynecol. 2004 Jul;191(1):182-7. doi: 10.1016/j.ajog.2004.03.088.</citation>
    <PMID>15295362</PMID>
  </reference>
  <reference>
    <citation>Wolf SJ, Bennett CJ, Dmochowski RR et al. (2012). Urologic Surgery Antimicrobial Prophylaxis. American Urological Association. Retrieved from http://www.auanet.org/guidelines/antimicrobial-prophylaxis-(2008-reviewed-and-validity-confirmed-2011-amended-2012)</citation>
  </reference>
  <reference>
    <citation>Harding GK, Nicolle LE, Ronald AR, Preiksaitis JK, Forward KR, Low DE, Cheang M. How long should catheter-acquired urinary tract infection in women be treated? A randomized controlled study. Ann Intern Med. 1991 May 1;114(9):713-9. doi: 10.7326/0003-4819-114-9-713.</citation>
    <PMID>2012351</PMID>
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    <citation>Niel-Weise BS, van den Broek PJ. Antibiotic policies for short-term catheter bladder drainage in adults. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD005428. doi: 10.1002/14651858.CD005428.</citation>
    <PMID>16034973</PMID>
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    <citation>Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.</citation>
    <PMID>25434837</PMID>
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    <citation>Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63. doi: 10.1086/650482.</citation>
    <PMID>20175247</PMID>
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    <citation>Rodriguez-Martinez JM, Ballesta S, Pascual A. Activity and penetration of fosfomycin, ciprofloxacin, amoxicillin/clavulanic acid and co-trimoxazole in Escherichia coli and Pseudomonas aeruginosa biofilms. Int J Antimicrob Agents. 2007 Oct;30(4):366-8. doi: 10.1016/j.ijantimicag.2007.05.005. Epub 2007 Jul 5. No abstract available.</citation>
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    <citation>Sastry S, Doi Y. Fosfomycin: Resurgence of an old companion. J Infect Chemother. 2016 May;22(5):273-80. doi: 10.1016/j.jiac.2016.01.010. Epub 2016 Feb 28.</citation>
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    <citation>Jancel T, Dudas V. Management of uncomplicated urinary tract infections. West J Med. 2002 Jan;176(1):51-5. doi: 10.1136/ewjm.176.1.51. No abstract available.</citation>
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  <reference>
    <citation>Goettsch WG, Janknegt R, Herings RM. Increased treatment failure after 3-days' courses of nitrofurantoin and trimethoprim for urinary tract infections in women: a population-based retrospective cohort study using the PHARMO database. Br J Clin Pharmacol. 2004 Aug;58(2):184-9. doi: 10.1111/j.1365-2125.2004.02106.x.</citation>
    <PMID>15255801</PMID>
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  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <results_first_submitted>April 22, 2020</results_first_submitted>
  <results_first_submitted_qc>May 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2020</results_first_posted>
  <last_update_submitted>August 5, 2022</last_update_submitted>
  <last_update_submitted_qc>August 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nitrofurantoin</keyword>
  <keyword>Prolapse</keyword>
  <keyword>Pelvic Organ Prolapse</keyword>
  <keyword>Anti-incontinence procedure</keyword>
  <keyword>Urinary retention</keyword>
  <keyword>Urinary Tract Infection</keyword>
  <keyword>Short-term catheterization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitrofurantoin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03287089/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03287089/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Consecutive women were prescreened for eligibility and introduced to the study prior to surgery. Women with postoperative urinary retention following pelvic organ prolapse and/or incontinence surgery were approached for study inclusion at the time of their postoperative in-office voiding trial between September 2017 and April 2019.</recruitment_details>
      <pre_assignment_details>Women were deemed as &quot;enrolled&quot; once they consented and randomized. No enrolled participants were excluded with this definition.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nitrofurantoin</title>
          <description>Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal&#xD;
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Receives twice daily matching placebo for 5 days following catheter removal&#xD;
Placebo Oral Tablet: Matching placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analyses were conducted on Intention-to-Treat Principle</population>
      <group_list>
        <group group_id="B1">
          <title>Nitrofurantoin</title>
          <description>Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal&#xD;
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Receives twice daily matching placebo for 5 days following catheter removal&#xD;
Placebo Oral Tablet: Matching placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="82"/>
            <count group_id="B2" value="82"/>
            <count group_id="B3" value="164"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.6" spread="11.7"/>
                    <measurement group_id="B2" value="61.1" spread="12.4"/>
                    <measurement group_id="B3" value="61.4" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI), kg/m^2</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.1" spread="4.7"/>
                    <measurement group_id="B2" value="28.6" spread="5"/>
                    <measurement group_id="B3" value="27.8" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>Parity</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="B3" value="2" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>POP-Q Stage</title>
          <description>POP-Q is a measure of the degree of Pelvic Organ Prolapse present. Stage 0 is essentially no prolapse or descent of pelvic organs; higher stages indicate progressively larger degrees of prolapse. Stage 4 is the highest stage, and indicated prolapse that is equal to or greater than the total vaginal length (in cm) minus 2 cm</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="B3" value="2" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Menopausal Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Premenopausal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postmenopausal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Postmenopausal Hormone Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Hormone Therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vaginal Estrogen Therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Systemic Hormonal Therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Smoking</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Recurrent UTI</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Mellitus</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preoperative PVR Volume (mL)</title>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.9" spread="92.6"/>
                    <measurement group_id="B2" value="45.3" spread="55.7"/>
                    <measurement group_id="B3" value="51.4" spread="75.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Creatinine Clearance</title>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.1" spread="30.1"/>
                    <measurement group_id="B2" value="94.2" spread="34.9"/>
                    <measurement group_id="B3" value="89.1" spread="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Procedure</title>
          <description>Participants may have had more than one procedure listed</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mid urethral sling surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burch colposuspension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anterior repair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posterior repair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hysterectomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginectomy/colpocleisis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uterosacral ligament suspension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sacrospinous ligament fixation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Iliococcygeus vault suspension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sacral colpopexy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginal mesh excision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Operative Time (mins)</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="134" spread="80.8"/>
                    <measurement group_id="B2" value="142.9" spread="86.9"/>
                    <measurement group_id="B3" value="138.4" spread="83.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated Blood Loss (mL)</title>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.5" spread="35.5"/>
                    <measurement group_id="B2" value="60.9" spread="61.6"/>
                    <measurement group_id="B3" value="53.2" spread="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of Hospital Stay (days)</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B2" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Catheterization (days)</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="B2" value="3" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="B3" value="3" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>UTI</title>
        <description>Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery</description>
        <time_frame>within 30 days of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nitrofurantoin</title>
            <description>Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal&#xD;
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Receives twice daily matching placebo for 5 days following catheter removal&#xD;
Placebo Oral Tablet: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>UTI</title>
          <description>Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.84</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Number of participants with an adverse event only related to study drug administration</description>
        <time_frame>within 30 days of surgery</time_frame>
        <population>This is the total number of participants with an allergy or intolerance to the study medication.These adverse symptoms included: hives, pruritus, rash, anaphylaxis, nausea, vomiting, diarrhea, and other.</population>
        <group_list>
          <group group_id="O1">
            <title>Nitrofurantoin</title>
            <description>Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal&#xD;
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Receives twice daily matching placebo for 5 days following catheter removal&#xD;
Placebo Oral Tablet: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Number of participants with an adverse event only related to study drug administration</description>
          <population>This is the total number of participants with an allergy or intolerance to the study medication.These adverse symptoms included: hives, pruritus, rash, anaphylaxis, nausea, vomiting, diarrhea, and other.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Allergy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nausea</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vomiting</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Diarrhea</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.44</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Compliance</title>
        <description>Compliance assessed by use of a medication diary during treatment period</description>
        <time_frame>within 30 days of surgery</time_frame>
        <population>Compliance was defined as the number pills taken divided by total number of pills dispensed (10). The closer this ratio is to &quot;1&quot; the better the compliance. The closer the ratio is to &quot;0&quot; the worse the compliance</population>
        <group_list>
          <group group_id="O1">
            <title>Nitrofurantoin</title>
            <description>Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal&#xD;
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Receives twice daily matching placebo for 5 days following catheter removal&#xD;
Placebo Oral Tablet: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Compliance</title>
          <description>Compliance assessed by use of a medication diary during treatment period</description>
          <population>Compliance was defined as the number pills taken divided by total number of pills dispensed (10). The closer this ratio is to &quot;1&quot; the better the compliance. The closer the ratio is to &quot;0&quot; the worse the compliance</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="0.18"/>
                    <measurement group_id="O2" value="0.96" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.68</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days (from surgery until 30 days postop)</time_frame>
      <desc>Adverse events data related to study medication was collected (i.e. allergies and/or intolerances)</desc>
      <group_list>
        <group group_id="E1">
          <title>Nitrofurantoin</title>
          <description>Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal&#xD;
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Receives twice daily matching placebo for 5 days following catheter removal&#xD;
Placebo Oral Tablet: Matching placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Medication Intolerance</sub_title>
                <description>Nausea</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="82"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medication Intolerance</sub_title>
                <description>Headache</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Medication Intolerance</sub_title>
                <description>Joint Pain</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dina Bastawros, MD</name_or_title>
      <organization>Atrium Health</organization>
      <phone>336-718-1970</phone>
      <email>dina.bastawros@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03287089
org study id: Pro00022622
nct id: NCT03287089
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the
      efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for
      the prevention of catheter-associated urinary tract infections in patients with postoperative
      short-term catheterization following pelvic reconstructive surgery and/or urinary
      incontinence surgery.

      Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail
      their post-operative voiding trial will be included in the study. Upon successfully passing
      and in-office voiding trial at the time of catheter removal, they will be randomized to
      either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily
      for 5 days following catheter removal. The primary outcome will be the treatment of
      clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes
      include adverse events associated with nitrofurantoin use and medication compliance.

      Primary and secondary outcomes will be evaluated with Student t test and chi squared or
      Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to
      nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05, we
      should recruit a total of 164 patients.
Urinary tract infections (UTI) are the most common hospital-acquired infections, accounting
      for nearly 30% of cases of nosocomial infections and affecting nearly 1 million people per
      year.

      Following pelvic reconstructive and urinary incontinence surgery, UTIs are one of the most
      common complications with a risk between 8.9%-34%. The baseline risk of UTI associated with
      pelvic floor surgery ranges between 5-35%, increasing greatly with catheterization.

      Postoperative voiding dysfunction and incomplete bladder emptying is common following pelvic
      reconstructive and incontinence surgeries, with incidence ranging from 2.5 % to 31%. As a
      result, these women may have additional catheterization for a short period of time, which
      increases the risk of UTI. There is a 15-20% risk of developing a postoperative UTI with
      short-term catheterization, even if the catheter remains in place for merely 24 hours. The
      risk of UTI increases 5-10% each day the catheter is left in place.

      Numerous studies have been conducted to evaluate different prophylactic antibiotic regimens
      to help decrease the rate of postoperative catheter-associated UTIs. Many of these studies
      have shown precedent for the use of antibiotic prophylaxis.

      Nitrofurantoin has been evaluated as a prophylactic regimen for use during short-term
      catheterization. These studies had favorable results, decreasing the incidence of UTI
      postoperatively.

      Although there are a few studies showing favorable results for the use of prophylactic
      nitrofurantoin during catheterization after pelvic surgery, the optimal timing of antibiotic
      administration and length of dosing regimen is not well defined. The American Urological
      Association (AUA) recommends empiric antibiotic treatment at the time of external urinary
      catheter removal in patients with risk factors, such as tobacco use, advanced age, and
      anatomic abnormalities of the urinary tract. The AUA Panel does cite that bacteriuria in the
      setting of noninfectious urinary tract disease is a risk factor for bacteremia, and, thus,
      prophylactic antibiotic treatment at time the of catheter removal may be indicated. The AUA
      does recommend empiric antibiotic treatment at the removal of an external urinary catheter in
      patients with risk factors. However, there is no standardization concerning the type of
      antibiotic to be used or treatment duration.

      Although there are a few studies showing favorable results for use of nitrofurantoin during
      catheterization after pelvic surgery, there are no clearly defined recommendations regarding
      its use for urinary tract infection prevention after catheter removal. Therefore, the
      objective of our study is to examine the effects of administration of nitrofurantoin therapy
      at the time of Foley catheter removal for the prevention of catheter-associated UTI in
      patients undergoing POP and/or urinary incontinence surgery.

      Primary Objective:

      To evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter
      discontinuation for the prevention of catheter-associated urinary tract infections in
      patients with postoperative short-term catheterization following pelvic reconstructive
      surgery. The primary outcome will be the treatment of clinically suspected and/or
      culture-proven UTI within 30 days of surgery.

      Secondary Objective:

      To evaluate adverse outcomes related to study medications in each group and to evaluate
      medication compliance

      Null Hypothesis:

      The null hypothesis is that the administration of nitrofurantoin will not reduce the rate of
      UTI compared with placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: UTI
time frame: within 30 days of surgery
description: Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery
measure: Adverse Events
time frame: within 30 days of surgery
description: Number of participants with an adverse event only related to study drug administration
measure: Medication Compliance
time frame: within 30 days of surgery
description: Compliance assessed by use of a medication diary during treatment period
arm group label: Nitrofurantoin
arm group type: Active Comparator
description: Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
arm group label: Placebo
arm group type: Placebo Comparator
description: Receives twice daily matching placebo for 5 days following catheter removal
intervention type: Drug
intervention name: Nitrofurantoin 100 MG
description: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
arm group label: Nitrofurantoin
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Matching placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dina Bastawros, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Nitrofurantoin
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 