Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

July 30, 2024 updated by: Eric Hurtado, The Cleveland Clinic
This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study would be powered to detect differences in UTIs and Foley catheter re-insertion rates. Assuming a 10% drop-out rate, 100 total subjects should be enrolled in the study.

All patients that meet the appropriate inclusion criteria and are scheduled for outpatient pelvic floor surgery will be considered for the study. Patients will be counseled about the study either in the office during a surgical planning office visit, over a pre-operative telephone call, or in the pre-operative area just prior to surgery. Consents will be signed in the pre-operative area.

After surgery, the patient will be given a standardized voiding trial as per the usual protocol. If the patient is un-successful in emptying her bladder she will be discharged home with an indwelling Foley catheter with antibiotics. On post-operative day (POD) #1 the patient will be re-assessed for meeting eligibility requirements and will be called and randomized to either the early voiding trial group (EVT) or the late voiding trial group (LVT). Subjects in EVT will be scheduled for a repeat VT on POD#2, POD#3, or POD#4, whereas those in LVT will be scheduled for a repeat VT on or after POD#7. Subjects that are unsuccessful in the repeat VT will have a Foley catheter re-inserted and will return for another VT in 5-7 days. Subjects who fail the third VT from either group will have the Foley catheter replaced and will return for another office VT after waiting an additional 5-7 days or will be started on clean intermittent self-catheterization.

Subjects will be monitored for a 6 week period for voiding and urinary symptoms. Urine will be tested via in-office urinalysis at each office visit, including pre-operatively, and will be sent for a urine culture per usual practice based upon abnormal urinalysis results. Urine cultures that grow out a single organism >10,000 CFU will be treated with appropriate antibiotics. In addition, patients will complete quality of life questionnaires at the time of catheter removal, the standard 2 week post-op visit and at 6weeks post-operatively.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients
  • Over 18 years old
  • Speak English and are capable of giving informed consent and are able to complete the English patient questionnaire
  • Are willing to return to the office for all necessary visits associated with the study
  • Had outpatient gynecology pelvic floor surgery for prolapse or stress urinary incontinence
  • Failed the voiding trial in the recovery room
  • Discharged to home on POD#0

Exclusion Criteria:

  • Pre-operative urinary retention as defined as PVR > 200ml
  • Prior incontinence surgery
  • Passed the voiding trial in the recovery room
  • Require prolonged catheterization due to urethral/bladder abnormality (ie vesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injury or for intensive post-operative monitoring
  • Patients who take any post-operative antibiotics, other than prophylaxis during catheterization, for reasons other than a UTI as diagnosed and prescribed as part of the study
  • Patients who take any supplements to prevent UTIs, including but not limited to D-Mannose, Hiprex, or Ellura
  • Receive any post-operative vaginal estrogen during the study period
  • Have any neurological conditions that may affect bladder function (ie. Multiple sclerosis, spinal cord injuries, etc.)
  • Patients with pre-operative narcotic medication use due to chronic pain
  • Patients who take any over-active bladder medication within one week of their surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Voiding Trial

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.

Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4
Device: Foley catheter - Early Voiding Trial

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.

Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.
Active Comparator: Late Voiding Trial

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.

Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Device: Foley catheter - Late Voiding Trial

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.

Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failed Office Voiding Trials
Time Frame: within 8 days of surgery
Determine the rates of failed voiding trials in each of the two groups
within 8 days of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Tract Infections
Time Frame: within 6 weeks of surgery
Determine the rates of urinary tract infections in each of the two groups
within 6 weeks of surgery
Rate of Bother From Urinary Catheter
Time Frame: within 6 weeks of surgery
Determine the rates of patient satisfaction in each of the two groups using a Likert scale (1= very bothersome; 5= Not bothersome at all)
within 6 weeks of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Jeffrey Schachar, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2017

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimated)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLA 16-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There no plan to make individual participant data available to other researchers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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