Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Not Applicable

Completed

Conditions: Surgery
Urinary Incontinence,Stress
Pelvic Organ Prolapse

Interventions: Device: Foley catheter - Late Voiding Trial
Device: Foley catheter - Early Voiding Trial

Registration Number: NCT03048682

Lead Sponsor: The Cleveland Clinic

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 64

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late Voiding Trial	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 this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Early Voiding Trial	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 this group will have their repeat voiding trial on post-op day #2, 3, or 4

Primary Outcome Measures

Name	Time	Method
Failed Office Voiding Trials	within 8 days of surgery	Determine the rates of failed voiding trials in each of the two groups

Secondary Outcome Measures

Name	Time	Method
Rate of Bother From Urinary Catheter	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)
Urinary Tract Infections	within 6 weeks of surgery	Determine the rates of urinary tract infections in each of the two groups

Trial Locations

Locations (2): Cleveland Clinic Florida
🇺🇸
Weston, Florida, United States
Wake Forest Baptist Health
🇺🇸
Winston-Salem, North Carolina, United States