<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/NCT02189291</url>
  </required_header>
  <id_info>
    <org_study_id>00010603</org_study_id>
    <nct_id>NCT02189291</nct_id>
  </id_info>
  <brief_title>Study to Assess Duration of Indwelling Catheter After Sacrocolpopexy</brief_title>
  <acronym>CARESS</acronym>
  <official_title>When to Remove the Indwelling Catheter After Minimally Invasive Sacrocolpopexy?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives&#xD;
&#xD;
      The objective of this study is to help identify the best practice regarding the use of&#xD;
      indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a&#xD;
      randomized controlled trial comparing the immediate removal of indwelling urethral catheter,&#xD;
      after minimally invasive sacrocolpopexy, to the present standard catheter removal on post&#xD;
      operative day one. Evidence based catheter management will be helpful to both providers and&#xD;
      patients in post-operative decision making.&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
      Aim 1: To demonstrate that immediate removal of catheter after minimally invasive&#xD;
      sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.&#xD;
&#xD;
      Aim 2: To demonstrate that immediate removal of catheter after minimally invasive&#xD;
      sacrocolpopexy confers no increased risk of re-catheterization.&#xD;
&#xD;
      Aim 3: To demonstrate that immediate removal of catheter after minimally invasive&#xD;
      sacrocolpopexy decreases the occurrence of urinary tract infection.&#xD;
&#xD;
      Design&#xD;
&#xD;
      A randomized controlled trial comparing the standard overnight indwelling urethral&#xD;
      catheterization with removal of catheter immediately post surgery after minimally invasive&#xD;
      sacrocolpopexy, at Oregon Health &amp; Science University.&#xD;
&#xD;
      Outcome measures&#xD;
&#xD;
      Primary outcome measures are hospital stay in hours after completion of surgery and need for&#xD;
      re-catheterization. Hospital stay will be counted from the time the patient leaves the&#xD;
      operating room to the time she leaves the hospital. To avoid confounding, investigators are&#xD;
      only including the first / morning case of the day. For re-catheterization, investigators&#xD;
      will evaluate if patient was able to void after completion of surgery. Investigators will&#xD;
      compare the post voiding residuals, the need for re-catheterizations and the numbers of&#xD;
      patients going home with an indwelling catheter between the two groups. Investigators will&#xD;
      also compare the number of urinary tract infections, as documented by urine culture and&#xD;
      subsequent treatment, between the two groups.&#xD;
&#xD;
      Study Subjects&#xD;
&#xD;
      Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be&#xD;
      invited to participate in the study during their preoperative visit. If they agree to&#xD;
      participation, this will be noted in their chart. Randomization to group will occur&#xD;
      immediately following surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives&#xD;
&#xD;
      The objective of this study is to help identify the best practice regarding the use of&#xD;
      indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a&#xD;
      randomized controlled trial comparing the immediate removal of indwelling urethral catheter,&#xD;
      after minimally invasive sacrocolpopexy, to the present standard catheter removal on post&#xD;
      operative day one. Evidence based catheter management will be helpful to both providers and&#xD;
      patients in post-operative decision making.&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
      Placement of indwelling catheter after minimally invasive pelvic organ prolapse (POP) surgery&#xD;
      is routine practice. There is limited evidence to support the use of overnight indwelling&#xD;
      catheters, and despite this, the use of catheters after urogynecologic surgery remains common&#xD;
      practice. The objective of this study is to help identify the best practice regarding the use&#xD;
      of indwelling catheter after minimally invasive urogynecologic surgery. Dunn et al found that&#xD;
      immediate removal of catheter after completion of an uncomplicated abdominal or vaginal&#xD;
      hysterectomy was not associated with re-catheterization, urinary tract infections or fever.&#xD;
      They also found that patients in whom the catheter was removed immediately had less pain&#xD;
      compared to the patients who had indwelling catheter for 24 hours. The applicability of this&#xD;
      study to Urogynecology is limited by the fact that patients with incontinence and / or&#xD;
      prolapse were not included in it. Use of catheters after surgery may be convenient for&#xD;
      providers, but the benefit to the patient is uncertain. Investigators believe that evidence&#xD;
      with regards to the optimal use of catheter use in urogynecologic surgery will be helpful to&#xD;
      the providers.&#xD;
&#xD;
      Risk of urinary tract infection increases the longer an indwelling catheter stays in a&#xD;
      patient. Urinary tract infections associated with catheters (CAUTI) are responsible for 40%&#xD;
      of hospital acquired infections. CAUTI are associated with 387, 550 hospital acquired&#xD;
      infections in a year, which could be prevented. Investigators believe that avoiding placement&#xD;
      of catheter after minimally invasive urogynecologic surgery will result in shorter hospital&#xD;
      stay and reduction in CAUTI, thereby improving the quality and cost of health care.&#xD;
&#xD;
      Aim 1: To demonstrate that immediate removal of catheter after minimally invasive&#xD;
      sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.&#xD;
&#xD;
      Aim 2: To demonstrate that immediate removal of catheter after minimally invasive&#xD;
      sacrocolpopexy confers no increased risk of re-catheterization.&#xD;
&#xD;
      Aim 3: To demonstrate that immediate removal of catheter after minimally invasive&#xD;
      sacrocolpopexy decreases the occurrence of urinary tract infection.&#xD;
&#xD;
      Background&#xD;
&#xD;
      Most patients stay in hospital for a 23-hour observation following minimally invasive&#xD;
      urogynecologic surgery. The usual practice is to leave the indwelling urethral catheter&#xD;
      overnight after these procedures. The use of indwelling catheters after surgery is carried&#xD;
      for multiple reasons, including measuring urinary output and prevention of urinary retention&#xD;
      after surgery. The use of indwelling Foley catheter after surgery is associated with&#xD;
      prolonged hospital stay, fever and urinary tract infection. A study by Haakvort et al&#xD;
      compared removal of indwelling catheter on post operative day 1 to longer catheterization&#xD;
      after vaginal and found a tenfold reduction in urinary tract infections.&#xD;
&#xD;
      The removal of indwelling catheter may affect the length of stay in hospital, with associated&#xD;
      budgetary and economic implications. One study found that removal of indwelling catheter at&#xD;
      midnight results in patients being discharged 0.7 days earlier than patients who had their&#xD;
      catheters removed in the morning. This results in shorter length of hospital stay and&#xD;
      improved discharge planning. There is a wide variation in practice and policies regarding&#xD;
      catheter removal. With no clear evidence-based practice regarding catheter removal, and lack&#xD;
      of data in literature with regards to catheter removal after urogynecologic surgery,&#xD;
      practices vary among physicians and institutions. Audits in British hospitals found that&#xD;
      almost half of the catheters were removed either at the discretion of the nurse or at the&#xD;
      time of rounds in the morning. Another study found that when the catheters were scheduled to&#xD;
      be removed in the morning, only 70% were removed in time.&#xD;
&#xD;
      Dunn et al looked into removal of indwelling catheter immediately after hysterectomy compared&#xD;
      to removal after 24 hours. They found that immediate removal of catheter after surgery was&#xD;
      not associated with any adverse outcomes or need for re-catheterization, and patients with&#xD;
      immediate removal reported significantly less pain compared to their counterparts who had&#xD;
      catheter removal at 24 hours. Similarly, Alessandri found that women who had their catheter&#xD;
      removed early had a shorter mean ambulation time and their hospital stay was shorter by 19&#xD;
      hours. This shows the economic benefit with early discharge associated with early catheter&#xD;
      removal, however such a study is lacking in urogynecology literature.&#xD;
&#xD;
      In addition to potential benefits to health care costs, immediate catheter removal has&#xD;
      several health benefits. There is evidence that early ambulation reduces the incidence of&#xD;
      clinically evident deep venous thrombosis. Therefore, early removal of indwelling urethral&#xD;
      catheter after surgery may contribute towards reducing postoperative morbidity by reducing&#xD;
      the incidence of post operative deep venous thrombosis and decrease health care cost by&#xD;
      aiding towards early discharge. Another advantage of immediate catheter removal after surgery&#xD;
      is lower incidence of urinary tract infection.&#xD;
&#xD;
      There are few studies offering insight into postoperative voiding efficiency after&#xD;
      uncomplicated minimally invasive urogynecologic surgery. There is variation in practice with&#xD;
      regards to the length of time the indwelling catheter is left in place. Multiple factors&#xD;
      contribute to how long a catheter stays. In the absence of strong evidence, this decision&#xD;
      depends on physician preference, staff convenience and patient tolerance. The use of&#xD;
      indwelling urethral catheter is the usual practice after gynecologic and POP surgery. Despite&#xD;
      this routine practice, there seems to be little evidence supporting the use of indwelling&#xD;
      urethral catheter after gynecologic surgery. Generally, the indwelling urethral catheter is&#xD;
      used after surgery for monitoring output, or if the patient is not mobile. This may not be&#xD;
      the usual case after urogynecologic surgery. Some of the reasons for routine use of catheter&#xD;
      after urogynecologic surgery include allowing bladder emptying as voiding may be difficult&#xD;
      due to the effects of the surgery, such as pain or swelling of surrounding soft tissues. The&#xD;
      routine use of indwelling catheters after routine urogynecologic surgery carries the risk of&#xD;
      morbidity including detrusor overactivity, urinary tract infection or pain in urethra.&#xD;
&#xD;
      There is a lack of agreement among providers regarding the optimal time for removal of&#xD;
      urethral catheter after surgery. Usual practices are based on provider preference and the&#xD;
      already established institution practices rather than evidence based practice. Although&#xD;
      different institutions and providers have different practices and policies, there is no&#xD;
      evidence based practice regarding the effect of the time when catheter is removed or for the&#xD;
      length of time catheter is left in place prior to removal after surgery. Most places will&#xD;
      leave the catheter overnight after surgery. One possible reason for that may be that the&#xD;
      reduced staff at night may not respond to the complication of urinary retention, following&#xD;
      catheter removal. Another perceived reason for leaving the catheter in overnight is that&#xD;
      patients will rest through the night and then get back to their normal voiding the next day,&#xD;
      once the catheter is removed in the morning. Cochrane review by Griffiths and Fernandez had&#xD;
      suggested the need for randomized trials to address questions regarding catheter removal&#xD;
      among discrete subgroups and specialties. The usual practice of indwelling foley catheter&#xD;
      after urogynecologic surgery may be convenience to the providers, but there is limited&#xD;
      evidence in literature regarding what benefits patients gain from this practice.&#xD;
&#xD;
      Outcome measures&#xD;
&#xD;
      Primary outcome measures are hospital stay in hours after completion of surgery and need for&#xD;
      re-catheterization. Hospital stay will be counted from the time the patient leaves the&#xD;
      operating room to the time she leaves the hospital. To avoid confounding, investigators are&#xD;
      only including the first / morning case of the day. For re-catheterization, investigators&#xD;
      will evaluate if patient was able to void after completion of surgery. Investigators will&#xD;
      compare the post voiding residuals, the need for re-catheterizations and the numbers of&#xD;
      patients going home with an indwelling catheter between the two groups. Investigators will&#xD;
      also compare the number of urinary tract infections, as documented by urine culture and&#xD;
      subsequent treatment, between the two groups.&#xD;
&#xD;
      Data Collection&#xD;
&#xD;
      Investigators will obtain demographic information. On post operative day 1, investigators&#xD;
      will obtain patient satisfaction and pain scores. Pain score will be obtained with the use of&#xD;
      pictorial &quot;Wong Scale,&quot; assessing level of pain and location (i.e., bladder or urethra vs.&#xD;
      the surgical site). Furthermore, patients will be asked whether they will use the same&#xD;
      treatment again (yes or no).&#xD;
&#xD;
      All patients are to expect discharge the following day and counseled as such. Patients&#xD;
      assigned to immediate removal will undergo the following protocol: The indwelling catheter&#xD;
      will be removed prior to exiting the operating room. If the patient has an urge to void&#xD;
      immediately post operatively, the void will be recorded and post void residual determined by&#xD;
      bladder scan. If the post void residual is no more than 1/3 of the total volume, the patient&#xD;
      will be considered to have passed the voiding trial and have no further intervention. In&#xD;
      patients with more than 1/3 post void residual or inability to void four hours after&#xD;
      completion of surgery, bladder volume will be checked with a bladder scan. In subjects with&#xD;
      less than 300 mL of urine, they will be given an additional two hours to void. For patients&#xD;
      with &gt;300 mL of urine, they will undergo straight catheterization and re-enter the voiding&#xD;
      trial cycle. For patients who have not voided at six hours, straight catheterization will be&#xD;
      performed and they will re-enter the voiding trial cycle and given four hours to void. This&#xD;
      process will continue for three total cycles (1st cycle post operative, two cycles&#xD;
      thereafter), at which time they will be given an indwelling catheter.&#xD;
&#xD;
      For patients assigned to catheter removal on post operative day one, investigators will&#xD;
      perform backfill voiding trial prior to catheter removal. Investigators are planning to&#xD;
      perform backfill voiding trial as it has not been shown to be inferior to waiting to void and&#xD;
      this will avoid confounding regarding the discharge time from hospital. Bladder will be&#xD;
      filled with 300 mL of sterile water and the indwelling catheter will then be removed. Patient&#xD;
      will be asked to void in a hat thereafter, if they are able to void at least 200 mL, they&#xD;
      would have completed a successful voiding trial. If they are unable to void, then&#xD;
      investigators will perform straight catheterization and allow them four hours to void.&#xD;
      Patients unable to pass the voiding trial after two attempts will go home with either an&#xD;
      indwelling catheter or performing self catheterization (depending on patient's comfort). For&#xD;
      the purpose of the study, patients going home with a catheter or self catheterization will be&#xD;
      in the same group of going home with a catheter. Investigators will compare the incidence of&#xD;
      urinary tract infections within four weeks after surgery, as documented by urine culture and&#xD;
      / or treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>4 weeks</time_frame>
    <description>Primary outcome measure is hospital stay in hours after completion of surgery. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Re-catheterization</measure>
    <time_frame>Upto 4 weeks</time_frame>
    <description>To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary tract infection</measure>
    <time_frame>upto 4 weeks</time_frame>
    <description>To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Urinary Tract Infections</condition>
  <condition>Urinary Retention</condition>
  <arm_group>
    <arm_group_label>Immediate catheter removal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The indwelling Foley catheter will be removed prior to exiting the operating room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post op day 1 catheter removal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to this group will follow the standard of care at present, with removal of indwelling catheter on the morning of postoperative day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate catheter removal</intervention_name>
    <description>The indwelling catheter will be removed prior to exiting the operating room.</description>
    <arm_group_label>Immediate catheter removal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Post op day 1 catheter removal</intervention_name>
    <description>For patients assigned to catheter removal on post operative day one, which is the standard of care at this point.</description>
    <arm_group_label>Post op day 1 catheter removal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing minimally invasive sacrocolpopexy&#xD;
&#xD;
          -  Sacrocolpopexy with or without concomitant procedures&#xD;
&#xD;
          -  Patients having the first start surgery of the day to standardize hospital time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Elevated post void residual (PVR)&#xD;
&#xD;
          -  Mobility problems&#xD;
&#xD;
          -  Neurological conditions&#xD;
&#xD;
          -  Intra-operative cystotomy or urinary tract injury&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad F Aslam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. John Hospital &amp; Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St John Hospital &amp; Medical Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Good Samaritan Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>March 13, 2019</last_update_submitted>
  <last_update_submitted_qc>March 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>W. Thomas Gregory</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Indwelling catheter</keyword>
  <keyword>Hospital stay</keyword>
  <keyword>Urinary tract infection</keyword>
  <keyword>Sacrocolpopexy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <!-- 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/NCT02189291
org study id: 00010603
nct id: NCT02189291
lead sponsor: 
has dmc: Yes
Objectives

      The objective of this study is to help identify the best practice regarding the use of
      indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a
      randomized controlled trial comparing the immediate removal of indwelling urethral catheter,
      after minimally invasive sacrocolpopexy, to the present standard catheter removal on post
      operative day one. Evidence based catheter management will be helpful to both providers and
      patients in post-operative decision making.

      Specific Aims

      Aim 1: To demonstrate that immediate removal of catheter after minimally invasive
      sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.

      Aim 2: To demonstrate that immediate removal of catheter after minimally invasive
      sacrocolpopexy confers no increased risk of re-catheterization.

      Aim 3: To demonstrate that immediate removal of catheter after minimally invasive
      sacrocolpopexy decreases the occurrence of urinary tract infection.

      Design

      A randomized controlled trial comparing the standard overnight indwelling urethral
      catheterization with removal of catheter immediately post surgery after minimally invasive
      sacrocolpopexy, at Oregon Health & Science University.

      Outcome measures

      Primary outcome measures are hospital stay in hours after completion of surgery and need for
      re-catheterization. Hospital stay will be counted from the time the patient leaves the
      operating room to the time she leaves the hospital. To avoid confounding, investigators are
      only including the first / morning case of the day. For re-catheterization, investigators
      will evaluate if patient was able to void after completion of surgery. Investigators will
      compare the post voiding residuals, the need for re-catheterizations and the numbers of
      patients going home with an indwelling catheter between the two groups. Investigators will
      also compare the number of urinary tract infections, as documented by urine culture and
      subsequent treatment, between the two groups.

      Study Subjects

      Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be
      invited to participate in the study during their preoperative visit. If they agree to
      participation, this will be noted in their chart. Randomization to group will occur
      immediately following surgery.
Objectives

      The objective of this study is to help identify the best practice regarding the use of
      indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a
      randomized controlled trial comparing the immediate removal of indwelling urethral catheter,
      after minimally invasive sacrocolpopexy, to the present standard catheter removal on post
      operative day one. Evidence based catheter management will be helpful to both providers and
      patients in post-operative decision making.

      Specific Aims

      Placement of indwelling catheter after minimally invasive pelvic organ prolapse (POP) surgery
      is routine practice. There is limited evidence to support the use of overnight indwelling
      catheters, and despite this, the use of catheters after urogynecologic surgery remains common
      practice. The objective of this study is to help identify the best practice regarding the use
      of indwelling catheter after minimally invasive urogynecologic surgery. Dunn et al found that
      immediate removal of catheter after completion of an uncomplicated abdominal or vaginal
      hysterectomy was not associated with re-catheterization, urinary tract infections or fever.
      They also found that patients in whom the catheter was removed immediately had less pain
      compared to the patients who had indwelling catheter for 24 hours. The applicability of this
      study to Urogynecology is limited by the fact that patients with incontinence and / or
      prolapse were not included in it. Use of catheters after surgery may be convenient for
      providers, but the benefit to the patient is uncertain. Investigators believe that evidence
      with regards to the optimal use of catheter use in urogynecologic surgery will be helpful to
      the providers.

      Risk of urinary tract infection increases the longer an indwelling catheter stays in a
      patient. Urinary tract infections associated with catheters (CAUTI) are responsible for 40%
      of hospital acquired infections. CAUTI are associated with 387, 550 hospital acquired
      infections in a year, which could be prevented. Investigators believe that avoiding placement
      of catheter after minimally invasive urogynecologic surgery will result in shorter hospital
      stay and reduction in CAUTI, thereby improving the quality and cost of health care.

      Aim 1: To demonstrate that immediate removal of catheter after minimally invasive
      sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.

      Aim 2: To demonstrate that immediate removal of catheter after minimally invasive
      sacrocolpopexy confers no increased risk of re-catheterization.

      Aim 3: To demonstrate that immediate removal of catheter after minimally invasive
      sacrocolpopexy decreases the occurrence of urinary tract infection.

      Background

      Most patients stay in hospital for a 23-hour observation following minimally invasive
      urogynecologic surgery. The usual practice is to leave the indwelling urethral catheter
      overnight after these procedures. The use of indwelling catheters after surgery is carried
      for multiple reasons, including measuring urinary output and prevention of urinary retention
      after surgery. The use of indwelling Foley catheter after surgery is associated with
      prolonged hospital stay, fever and urinary tract infection. A study by Haakvort et al
      compared removal of indwelling catheter on post operative day 1 to longer catheterization
      after vaginal and found a tenfold reduction in urinary tract infections.

      The removal of indwelling catheter may affect the length of stay in hospital, with associated
      budgetary and economic implications. One study found that removal of indwelling catheter at
      midnight results in patients being discharged 0.7 days earlier than patients who had their
      catheters removed in the morning. This results in shorter length of hospital stay and
      improved discharge planning. There is a wide variation in practice and policies regarding
      catheter removal. With no clear evidence-based practice regarding catheter removal, and lack
      of data in literature with regards to catheter removal after urogynecologic surgery,
      practices vary among physicians and institutions. Audits in British hospitals found that
      almost half of the catheters were removed either at the discretion of the nurse or at the
      time of rounds in the morning. Another study found that when the catheters were scheduled to
      be removed in the morning, only 70% were removed in time.

      Dunn et al looked into removal of indwelling catheter immediately after hysterectomy compared
      to removal after 24 hours. They found that immediate removal of catheter after surgery was
      not associated with any adverse outcomes or need for re-catheterization, and patients with
      immediate removal reported significantly less pain compared to their counterparts who had
      catheter removal at 24 hours. Similarly, Alessandri found that women who had their catheter
      removed early had a shorter mean ambulation time and their hospital stay was shorter by 19
      hours. This shows the economic benefit with early discharge associated with early catheter
      removal, however such a study is lacking in urogynecology literature.

      In addition to potential benefits to health care costs, immediate catheter removal has
      several health benefits. There is evidence that early ambulation reduces the incidence of
      clinically evident deep venous thrombosis. Therefore, early removal of indwelling urethral
      catheter after surgery may contribute towards reducing postoperative morbidity by reducing
      the incidence of post operative deep venous thrombosis and decrease health care cost by
      aiding towards early discharge. Another advantage of immediate catheter removal after surgery
      is lower incidence of urinary tract infection.

      There are few studies offering insight into postoperative voiding efficiency after
      uncomplicated minimally invasive urogynecologic surgery. There is variation in practice with
      regards to the length of time the indwelling catheter is left in place. Multiple factors
      contribute to how long a catheter stays. In the absence of strong evidence, this decision
      depends on physician preference, staff convenience and patient tolerance. The use of
      indwelling urethral catheter is the usual practice after gynecologic and POP surgery. Despite
      this routine practice, there seems to be little evidence supporting the use of indwelling
      urethral catheter after gynecologic surgery. Generally, the indwelling urethral catheter is
      used after surgery for monitoring output, or if the patient is not mobile. This may not be
      the usual case after urogynecologic surgery. Some of the reasons for routine use of catheter
      after urogynecologic surgery include allowing bladder emptying as voiding may be difficult
      due to the effects of the surgery, such as pain or swelling of surrounding soft tissues. The
      routine use of indwelling catheters after routine urogynecologic surgery carries the risk of
      morbidity including detrusor overactivity, urinary tract infection or pain in urethra.

      There is a lack of agreement among providers regarding the optimal time for removal of
      urethral catheter after surgery. Usual practices are based on provider preference and the
      already established institution practices rather than evidence based practice. Although
      different institutions and providers have different practices and policies, there is no
      evidence based practice regarding the effect of the time when catheter is removed or for the
      length of time catheter is left in place prior to removal after surgery. Most places will
      leave the catheter overnight after surgery. One possible reason for that may be that the
      reduced staff at night may not respond to the complication of urinary retention, following
      catheter removal. Another perceived reason for leaving the catheter in overnight is that
      patients will rest through the night and then get back to their normal voiding the next day,
      once the catheter is removed in the morning. Cochrane review by Griffiths and Fernandez had
      suggested the need for randomized trials to address questions regarding catheter removal
      among discrete subgroups and specialties. The usual practice of indwelling foley catheter
      after urogynecologic surgery may be convenience to the providers, but there is limited
      evidence in literature regarding what benefits patients gain from this practice.

      Outcome measures

      Primary outcome measures are hospital stay in hours after completion of surgery and need for
      re-catheterization. Hospital stay will be counted from the time the patient leaves the
      operating room to the time she leaves the hospital. To avoid confounding, investigators are
      only including the first / morning case of the day. For re-catheterization, investigators
      will evaluate if patient was able to void after completion of surgery. Investigators will
      compare the post voiding residuals, the need for re-catheterizations and the numbers of
      patients going home with an indwelling catheter between the two groups. Investigators will
      also compare the number of urinary tract infections, as documented by urine culture and
      subsequent treatment, between the two groups.

      Data Collection

      Investigators will obtain demographic information. On post operative day 1, investigators
      will obtain patient satisfaction and pain scores. Pain score will be obtained with the use of
      pictorial "Wong Scale," assessing level of pain and location (i.e., bladder or urethra vs.
      the surgical site). Furthermore, patients will be asked whether they will use the same
      treatment again (yes or no).

      All patients are to expect discharge the following day and counseled as such. Patients
      assigned to immediate removal will undergo the following protocol: The indwelling catheter
      will be removed prior to exiting the operating room. If the patient has an urge to void
      immediately post operatively, the void will be recorded and post void residual determined by
      bladder scan. If the post void residual is no more than 1/3 of the total volume, the patient
      will be considered to have passed the voiding trial and have no further intervention. In
      patients with more than 1/3 post void residual or inability to void four hours after
      completion of surgery, bladder volume will be checked with a bladder scan. In subjects with
      less than 300 mL of urine, they will be given an additional two hours to void. For patients
      with >300 mL of urine, they will undergo straight catheterization and re-enter the voiding
      trial cycle. For patients who have not voided at six hours, straight catheterization will be
      performed and they will re-enter the voiding trial cycle and given four hours to void. This
      process will continue for three total cycles (1st cycle post operative, two cycles
      thereafter), at which time they will be given an indwelling catheter.

      For patients assigned to catheter removal on post operative day one, investigators will
      perform backfill voiding trial prior to catheter removal. Investigators are planning to
      perform backfill voiding trial as it has not been shown to be inferior to waiting to void and
      this will avoid confounding regarding the discharge time from hospital. Bladder will be
      filled with 300 mL of sterile water and the indwelling catheter will then be removed. Patient
      will be asked to void in a hat thereafter, if they are able to void at least 200 mL, they
      would have completed a successful voiding trial. If they are unable to void, then
      investigators will perform straight catheterization and allow them four hours to void.
      Patients unable to pass the voiding trial after two attempts will go home with either an
      indwelling catheter or performing self catheterization (depending on patient's comfort). For
      the purpose of the study, patients going home with a catheter or self catheterization will be
      in the same group of going home with a catheter. Investigators will compare the incidence of
      urinary tract infections within four weeks after surgery, as documented by urine culture and
      / or treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Hospital stay
time frame: 4 weeks
description: Primary outcome measure is hospital stay in hours after completion of surgery. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital.
measure: Re-catheterization
time frame: Upto 4 weeks
description: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization.
measure: Urinary tract infection
time frame: upto 4 weeks
description: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection.
arm group label: Immediate catheter removal
arm group type: Experimental
description: The indwelling Foley catheter will be removed prior to exiting the operating room.
arm group label: Post op day 1 catheter removal
arm group type: Active Comparator
description: Patients assigned to this group will follow the standard of care at present, with removal of indwelling catheter on the morning of postoperative day 1.
intervention type: Procedure
intervention name: Immediate catheter removal
description: The indwelling catheter will be removed prior to exiting the operating room.
arm group label: Immediate catheter removal
intervention type: Procedure
intervention name: Post op day 1 catheter removal
description: For patients assigned to catheter removal on post operative day one, which is the standard of care at this point.
arm group label: Post op day 1 catheter removal
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Muhammad F Aslam, MD
role: Principal Investigator
affiliation: St. John Hospital & Medical Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: W. Thomas Gregory
investigator title: Associate Professor
mesh term: Urinary Tract Infections
mesh term: Urinary Retention
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse