<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/NCT03009968</url>
  </required_header>
  <id_info>
    <org_study_id>16-2888</org_study_id>
    <nct_id>NCT03009968</nct_id>
  </id_info>
  <brief_title>Reducing Postoperative Catheterization</brief_title>
  <official_title>Reducing Postoperative Catheterization After Urogynecology Surgery: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Translational and Clinical Sciences Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients&#xD;
      requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute&#xD;
      retention experience urinary tract infections in the postoperative period (6, 7). Many women&#xD;
      consider being discharged with a Foley catheter to be a surgical complication and describe&#xD;
      catheter use as the worst aspect of their surgery(8). At this time there is no consensus&#xD;
      within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best&#xD;
      assess voiding function postoperatively. FPMRS providers both within the United States and&#xD;
      around the world utilize a variety of void trial methods and varying criteria to determine&#xD;
      adequacy of post-operative voiding efficiency (5).&#xD;
&#xD;
      The traditional backfill assisted void trial method involves the assessment of a postvoid&#xD;
      residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently,&#xD;
      there have been efforts to determine ways to avoid the assessment of a PVR as it is&#xD;
      time-consuming and potentially exposes the patient to additional catheterizations (9, 10).&#xD;
      Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead&#xD;
      utilize a certain voided volume threshold to determine adequate voiding. However, to date, no&#xD;
      one has directly studied this approach or compared the traditional backfill assisted void&#xD;
      trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating&#xD;
      a more efficient void trial method, the investigators hope improve patients' postoperative&#xD;
      experience and reduce catheterization and risk of urinary tract infection (UTI).&#xD;
&#xD;
      This study aims to compare two void trial methodologies in order to help standardize&#xD;
      post-operative care in the urogynecology population. This study also has potential to lead to&#xD;
      an overall change in our field and improve the postoperative course for women across the&#xD;
      country and abroad.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data Collection Demographic characteristics (i.e. age, race, body mass index, medical&#xD;
      history) will be collected at the time of preoperative visit. On the day of surgery,&#xD;
      operative data will be recorded on a standard form to document procedures performed,&#xD;
      intra-operative complications (if any), EBL and operative time. Prior to discharge the&#xD;
      randomized void trial will be preformed. Data regarding the void trial will be documented on&#xD;
      a standard form and will include which void trial was performed, amount backfilled, amount&#xD;
      voided, post void residual when assessed, and if the patient was discharged voiding&#xD;
      spontaneously, with a Foley catheter or performing CISC. All subjects will be instructed to&#xD;
      call our clinical office to report any urinary complaints and treatment for UTI. Information&#xD;
      will be collected from electronic medical records regarding any office visits, urine cultures&#xD;
      performed or treatment for UTI during this 6-week period. Participants will be called 1 week&#xD;
      from the time of surgery to complete the Short-term Catheter Burden Questionnaire.&#xD;
&#xD;
      Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery.&#xD;
      Patients electing to participate in the study will be consented in a private exam to protect&#xD;
      confidentiality. Once consented the subjects will be assigned a subject identification number&#xD;
      for study identification purposes, which will consist of &quot;A&quot; if the patient's surgery is&#xD;
      performed at Rex Hospital or &quot;B&quot; if the patient's surgery is performed at Hillsborough. A&#xD;
      number will then follow the letter.&#xD;
&#xD;
      Void Trial Protocols&#xD;
&#xD;
        1. Traditional backfill assisted voiding trial (control): Backfill the bladder with up to&#xD;
           300 ml as tolerated of normal saline or sterile water through an indwelling Foley&#xD;
           catheter. The catheter is removed and the patient is given 15 minutes to void and the&#xD;
           voided volume is measured. A post void residual (PVR) is measured after voiding (or&#xD;
           attempt to void) using either an in and out catheter or a bladder scanner. The&#xD;
           participant is considered to have passed the void trial if they have a PVR of less than&#xD;
           100 mL or less than half the voided volume if voided volume is greater than 200 mL.&#xD;
&#xD;
        2. The post-void residual free voiding trial (intervention): Backfill the bladder with up&#xD;
           to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley&#xD;
           catheter. The catheter is removed and the patient is given 15 minutes to void and the&#xD;
           voided volume is measured. The participant is considered to have passed the void trial&#xD;
           if they void more than 1/2 the instilled volume. A PVR will not be performed.&#xD;
&#xD;
      If the participant fails the voiding trial through either method they will be discharged to&#xD;
      home with an indwelling catheter or with clean intermittent self-catheterization (CISC) per&#xD;
      the participants preference. Subjects with an indwelling catheter will return to clinic&#xD;
      within 1-3 days for a repeat voiding trial using the same voiding trial guidelines. If the&#xD;
      subject is discharged on clean intermittent self-catheterization (CISC) she will document her&#xD;
      voided volumes and PVRs at home. Our nurse will then call the participant every 1-2 business&#xD;
      days to determine when they can stop CISC (2 consecutive PVRs less than 100 mL). Nurses will&#xD;
      document all information into a standardized template in EPIC per routine clinic protocol.&#xD;
&#xD;
      Follow-Up Participants will be scheduled for their post-operative appointment at the time of&#xD;
      scheduling their surgery per usual protocol. They will be called 1 week after surgery to&#xD;
      complete a questionnaire. The postoperative visit usually takes place approximately 6 weeks&#xD;
      after surgery. Any additional visits or calls to Urogynecology clinic prior to their&#xD;
      post-operative appointment will be documented in the electronic medical record per routine&#xD;
      clinical practice.&#xD;
&#xD;
      All efforts will be made to ensure minimal loss to follow-up of participants. This plan may&#xD;
      include efforts such as telephone follow-up or electronic medical record communication with&#xD;
      the patient.&#xD;
&#xD;
      Week 1 Phone Call The patient will be called one week after their surgery to answer the&#xD;
      questions from the Short-Term Catheter Burden Questionnaire.&#xD;
&#xD;
      Week 6 Visit (-2 weeks/+2 weeks) The primary outcome will be assessed at the time of the&#xD;
      post-operative visit with confirmation of need for catheterization. At this visit the subject&#xD;
      will also have the patient complete a questionnaire regarding catheter use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 17, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of postoperative catheterization</measure>
    <time_frame>At the time of hospital discharge (0-1 days)</time_frame>
    <description>Rate of postoperative catheterization which is defined as failing the postoperative voiding trial requiring the patients to be discharged to home with a Foley catheter or using clean intermittent self-catheterization (CISC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of catheterization</measure>
    <time_frame>From the day of surgery to 6 weeks post op</time_frame>
    <description>The number of days the subjects use either an indwelling Foley catheter or clean intermittent self catheterization starting on day of surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment of clinical-suspected or culture proven urinary tract infection</measure>
    <time_frame>From the day of surgery to 6 weeks post op</time_frame>
    <description>Antibiotic therapy given for either empiric or culture-proven UTI within the 6 week postoperative period. Any UTI treatment provided within our clinic is routinely documented in the EMR with urine culture results available in laboratory results. Patients will also be instructed to have any records from treatment obtained outside the UNC system to be faxed to our research offices. At the 6 week postoperative visits participants will be asked as well whether they received any antibiotic treatment for UTI during the 6 week postoperative period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent in the Post Anesthesia Care Unit (PACU).</measure>
    <time_frame>0-24 hours</time_frame>
    <description>PACU time will be defined as the time from when the patient leaves the OR and the time the patient is discharged from the PACU. This information is routinely recorded in the EMR by anesthesia and nursing staff. This secondary outcome will only be used in participants who are being discharged to home from the PACU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short term catheter burden</measure>
    <time_frame>1 week</time_frame>
    <description>Short term catheter burden will be assess using a validated 6-item questionnaire that will be completed 1 week following surgery in patients who failed the post operative voiding trial and are sent home with either indwelling Foley catheter or performing CISC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of post-operative patient calls and subsequent clinic visits.</measure>
    <time_frame>From the day of surgery to 6 weeks post op</time_frame>
    <description>This will be calculated using electronic medical record documentation and will compare the number of post-operative patient calls and subsequent patient visits between the control and intervention group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Urinary Retention</condition>
  <condition>Urinary Incontinence</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Urinary Tract Infections</condition>
  <arm_group>
    <arm_group_label>Traditional backfill assisted voiding trial</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-void residual free voiding trial</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post-void residual free voiding trial</intervention_name>
    <description>Will proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual.</description>
    <arm_group_label>Post-void residual free voiding trial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The study will include women scheduled for pelvic organ prolapse surgery and/or stress&#xD;
        urinary incontinence surgery requiring a post-operative voiding trial.&#xD;
&#xD;
          1. 18 years or older&#xD;
&#xD;
          2. English speaking&#xD;
&#xD;
          3. Documented PVR of less than 100mL prior to surgery obtained either during a previous&#xD;
             clinic visit or at the time of their preoperative urodynamics evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Dependent on catheterization to void preoperatively&#xD;
&#xD;
          3. Patient's undergoing fistula repair, sacral neuromodulation, urethral&#xD;
             diverticulum/vaginal mass excision or mesh revision surgery&#xD;
&#xD;
          4. Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcella G Willis-Gray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC at Chapel Hill, Division of Female Pelvic Medicine and Reconstructive Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.</citation>
    <PMID>21860294</PMID>
  </reference>
  <reference>
    <citation>Schiotz HA, Tanbo TG. Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(4):476-81. doi: 10.1080/00016340500409877.</citation>
    <PMID>16612711</PMID>
  </reference>
  <reference>
    <citation>Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.</citation>
    <PMID>18060956</PMID>
  </reference>
  <reference>
    <citation>Hakvoort RA, Thijs SD, Bouwmeester FW, Broekman AM, Ruhe IM, Vernooij MM, Burger MP, Emanuel MH, Roovers JP. Comparing clean intermittent catheterisation and transurethral indwelling catheterisation for incomplete voiding after vaginal prolapse surgery: a multicentre randomised trial. BJOG. 2011 Aug;118(9):1055-60. doi: 10.1111/j.1471-0528.2011.02935.x. Epub 2011 Apr 11.</citation>
    <PMID>21481147</PMID>
  </reference>
  <reference>
    <citation>Hakvoort RA, Burger MP, Emanuel MH, Roovers JP. A nationwide survey to measure practice variation of catheterisation management in patients undergoing vaginal prolapse surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jul;20(7):813-8. doi: 10.1007/s00192-009-0847-4. Epub 2009 Mar 10.</citation>
    <PMID>19495543</PMID>
  </reference>
  <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>
    <PMID>20354678</PMID>
  </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>
    <PMID>24463669</PMID>
  </reference>
  <reference>
    <citation>Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.</citation>
    <PMID>14710061</PMID>
  </reference>
  <reference>
    <citation>Ingber MS, Vasavada SP, Moore CK, Rackley RR, Firoozi F, Goldman HB. Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report. J Urol. 2011 Mar;185(3):993-7. doi: 10.1016/j.juro.2010.10.050. Epub 2011 Jan 19.</citation>
    <PMID>21247598</PMID>
  </reference>
  <reference>
    <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>
  </reference>
  <reference>
    <citation>Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.</citation>
    <PMID>20410783</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>March 15, 2018</last_update_submitted>
  <last_update_submitted_qc>March 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03009968
org study id: 16-2888
nct id: NCT03009968
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients
      requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute
      retention experience urinary tract infections in the postoperative period (6, 7). Many women
      consider being discharged with a Foley catheter to be a surgical complication and describe
      catheter use as the worst aspect of their surgery(8). At this time there is no consensus
      within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best
      assess voiding function postoperatively. FPMRS providers both within the United States and
      around the world utilize a variety of void trial methods and varying criteria to determine
      adequacy of post-operative voiding efficiency (5).

      The traditional backfill assisted void trial method involves the assessment of a postvoid
      residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently,
      there have been efforts to determine ways to avoid the assessment of a PVR as it is
      time-consuming and potentially exposes the patient to additional catheterizations (9, 10).
      Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead
      utilize a certain voided volume threshold to determine adequate voiding. However, to date, no
      one has directly studied this approach or compared the traditional backfill assisted void
      trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating
      a more efficient void trial method, the investigators hope improve patients' postoperative
      experience and reduce catheterization and risk of urinary tract infection (UTI).

      This study aims to compare two void trial methodologies in order to help standardize
      post-operative care in the urogynecology population. This study also has potential to lead to
      an overall change in our field and improve the postoperative course for women across the
      country and abroad.
Data Collection Demographic characteristics (i.e. age, race, body mass index, medical
      history) will be collected at the time of preoperative visit. On the day of surgery,
      operative data will be recorded on a standard form to document procedures performed,
      intra-operative complications (if any), EBL and operative time. Prior to discharge the
      randomized void trial will be preformed. Data regarding the void trial will be documented on
      a standard form and will include which void trial was performed, amount backfilled, amount
      voided, post void residual when assessed, and if the patient was discharged voiding
      spontaneously, with a Foley catheter or performing CISC. All subjects will be instructed to
      call our clinical office to report any urinary complaints and treatment for UTI. Information
      will be collected from electronic medical records regarding any office visits, urine cultures
      performed or treatment for UTI during this 6-week period. Participants will be called 1 week
      from the time of surgery to complete the Short-term Catheter Burden Questionnaire.

      Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery.
      Patients electing to participate in the study will be consented in a private exam to protect
      confidentiality. Once consented the subjects will be assigned a subject identification number
      for study identification purposes, which will consist of "A" if the patient's surgery is
      performed at Rex Hospital or "B" if the patient's surgery is performed at Hillsborough. A
      number will then follow the letter.

      Void Trial Protocols

        1. Traditional backfill assisted voiding trial (control): Backfill the bladder with up to
           300 ml as tolerated of normal saline or sterile water through an indwelling Foley
           catheter. The catheter is removed and the patient is given 15 minutes to void and the
           voided volume is measured. A post void residual (PVR) is measured after voiding (or
           attempt to void) using either an in and out catheter or a bladder scanner. The
           participant is considered to have passed the void trial if they have a PVR of less than
           100 mL or less than half the voided volume if voided volume is greater than 200 mL.

        2. The post-void residual free voiding trial (intervention): Backfill the bladder with up
           to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley
           catheter. The catheter is removed and the patient is given 15 minutes to void and the
           voided volume is measured. The participant is considered to have passed the void trial
           if they void more than 1/2 the instilled volume. A PVR will not be performed.

      If the participant fails the voiding trial through either method they will be discharged to
      home with an indwelling catheter or with clean intermittent self-catheterization (CISC) per
      the participants preference. Subjects with an indwelling catheter will return to clinic
      within 1-3 days for a repeat voiding trial using the same voiding trial guidelines. If the
      subject is discharged on clean intermittent self-catheterization (CISC) she will document her
      voided volumes and PVRs at home. Our nurse will then call the participant every 1-2 business
      days to determine when they can stop CISC (2 consecutive PVRs less than 100 mL). Nurses will
      document all information into a standardized template in EPIC per routine clinic protocol.

      Follow-Up Participants will be scheduled for their post-operative appointment at the time of
      scheduling their surgery per usual protocol. They will be called 1 week after surgery to
      complete a questionnaire. The postoperative visit usually takes place approximately 6 weeks
      after surgery. Any additional visits or calls to Urogynecology clinic prior to their
      post-operative appointment will be documented in the electronic medical record per routine
      clinical practice.

      All efforts will be made to ensure minimal loss to follow-up of participants. This plan may
      include efforts such as telephone follow-up or electronic medical record communication with
      the patient.

      Week 1 Phone Call The patient will be called one week after their surgery to answer the
      questions from the Short-Term Catheter Burden Questionnaire.

      Week 6 Visit (-2 weeks/+2 weeks) The primary outcome will be assessed at the time of the
      post-operative visit with confirmation of need for catheterization. At this visit the subject
      will also have the patient complete a questionnaire regarding catheter use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of postoperative catheterization
time frame: At the time of hospital discharge (0-1 days)
description: Rate of postoperative catheterization which is defined as failing the postoperative voiding trial requiring the patients to be discharged to home with a Foley catheter or using clean intermittent self-catheterization (CISC).
measure: Duration of catheterization
time frame: From the day of surgery to 6 weeks post op
description: The number of days the subjects use either an indwelling Foley catheter or clean intermittent self catheterization starting on day of surgery.
measure: Treatment of clinical-suspected or culture proven urinary tract infection
time frame: From the day of surgery to 6 weeks post op
description: Antibiotic therapy given for either empiric or culture-proven UTI within the 6 week postoperative period. Any UTI treatment provided within our clinic is routinely documented in the EMR with urine culture results available in laboratory results. Patients will also be instructed to have any records from treatment obtained outside the UNC system to be faxed to our research offices. At the 6 week postoperative visits participants will be asked as well whether they received any antibiotic treatment for UTI during the 6 week postoperative period.
measure: Time spent in the Post Anesthesia Care Unit (PACU).
time frame: 0-24 hours
description: PACU time will be defined as the time from when the patient leaves the OR and the time the patient is discharged from the PACU. This information is routinely recorded in the EMR by anesthesia and nursing staff. This secondary outcome will only be used in participants who are being discharged to home from the PACU.
measure: Short term catheter burden
time frame: 1 week
description: Short term catheter burden will be assess using a validated 6-item questionnaire that will be completed 1 week following surgery in patients who failed the post operative voiding trial and are sent home with either indwelling Foley catheter or performing CISC.
measure: Number of post-operative patient calls and subsequent clinic visits.
time frame: From the day of surgery to 6 weeks post op
description: This will be calculated using electronic medical record documentation and will compare the number of post-operative patient calls and subsequent patient visits between the control and intervention group.
arm group label: Traditional backfill assisted voiding trial
arm group type: No Intervention
description: Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL.
arm group label: Post-void residual free voiding trial
arm group type: Experimental
description: The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed.
intervention type: Other
intervention name: Post-void residual free voiding trial
description: Will proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual.
arm group label: Post-void residual free voiding trial
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcella G Willis-Gray, MD
role: Principal Investigator
affiliation: UNC at Chapel Hill, Division of Female Pelvic Medicine and Reconstructive Surgery
facility: 
country: United States
citation: Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.
PMID: 21860294
citation: Schiotz HA, Tanbo TG. Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(4):476-81. doi: 10.1080/00016340500409877.
PMID: 16612711
citation: Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.
PMID: 18060956
citation: Hakvoort RA, Thijs SD, Bouwmeester FW, Broekman AM, Ruhe IM, Vernooij MM, Burger MP, Emanuel MH, Roovers JP. Comparing clean intermittent catheterisation and transurethral indwelling catheterisation for incomplete voiding after vaginal prolapse surgery: a multicentre randomised trial. BJOG. 2011 Aug;118(9):1055-60. doi: 10.1111/j.1471-0528.2011.02935.x. Epub 2011 Apr 11.
PMID: 21481147
citation: Hakvoort RA, Burger MP, Emanuel MH, Roovers JP. A nationwide survey to measure practice variation of catheterisation management in patients undergoing vaginal prolapse surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jul;20(7):813-8. doi: 10.1007/s00192-009-0847-4. Epub 2009 Mar 10.
PMID: 19495543
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.
PMID: 20354678
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.
PMID: 24463669
citation: Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.
PMID: 14710061
citation: Ingber MS, Vasavada SP, Moore CK, Rackley RR, Firoozi F, Goldman HB. Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report. J Urol. 2011 Mar;185(3):993-7. doi: 10.1016/j.juro.2010.10.050. Epub 2011 Jan 19.
PMID: 21247598
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.
PMID: 25434837
citation: Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.
PMID: 20410783
responsible party type: Sponsor
mesh term: Urinary Tract Infections
mesh term: Urinary Incontinence
mesh term: Urinary Retention
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No