Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Last updated: July 30, 2024
Sponsor: The Cleveland Clinic
Overall Status: Completed

Phase

N/A

Condition

Surgery

Genitourinary Prolapse

Enuresis

Treatment

Foley catheter - Late Voiding Trial

Foley catheter - Early Voiding Trial

Clinical Study ID

NCT03048682
FLA 16-123
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patients

  • Over 18 years old

  • Speak English and are capable of giving informed consent and are able to completethe English patient questionnaire

  • Are willing to return to the office for all necessary visits associated with thestudy

  • Had outpatient gynecology pelvic floor surgery for prolapse or stress urinaryincontinence

  • Failed the voiding trial in the recovery room

  • Discharged to home on POD#0

Exclusion

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 (ievesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injuryor for intensive post-operative monitoring

  • Patients who take any post-operative antibiotics, other than prophylaxis duringcatheterization, for reasons other than a UTI as diagnosed and prescribed as part ofthe study

  • Patients who take any supplements to prevent UTIs, including but not limited toD-Mannose, Hiprex, or Ellura

  • Receive any post-operative vaginal estrogen during the study period

  • Have any neurological conditions that may affect bladder function (ie. Multiplesclerosis, 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 theirsurgery

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Foley catheter - Late Voiding Trial
Phase:
Study Start date:
January 05, 2017
Estimated Completion Date:
November 30, 2019

Study 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.

Connect with a study center

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

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