Clinical trial NCT03048682: Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
Official title: Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Urinary Incontinence,Stress
Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2017-02-09
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Failed Office Voiding Trials
timeFrame: within 8 days of surgery
Secondary outcomes:
measure: Urinary Tract Infections
timeFrame: within 6 weeks of surgery
measure: Rate of Bother From Urinary Catheter
timeFrame: within 6 weeks of surgery
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: The Cleveland Clinic
name: Jeffrey Schachar, MD
role: PRINCIPAL_INVESTIGATOR
References:
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