Clinical trial NCT02753920: Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension
Official title: A Randomized, Controlled Trial After Vaginal Apex Suspension Comparing Force of Stream to Traditional Retrograde Fill Voiding Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Apical Prolapse
Keywords: voiding trial
prolapse
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Voiding difficulties are common after prolapse and incontinence surgeries. All patients after vaginal prolapse surgery must complete a voiding trial if they are to be discharged home without a catheter. Accepted protocols for voiding trials after prolapse and incontinence surgeries do not exist. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less postoperative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having a vaginal apex suspension surgery.

Detailed description: It is common to have voiding difficulties after prolapse and incontinence surgeries. Difficulties in voiding are seen in up to 47% of patients after transvaginal prolapse surgery in the immediate hours postoperatively (6). Accepted protocols for voiding trials after prolapse and incontinence surgeries do not exist. Traditionally, many surgeons measure postvoid residual (PVR) urine volume to assess incomplete bladder emptying by retrograde filling the bladder with a predetermined amount of normal saline or water. The catheter is then removed and the patient is permitted to void into a collection basin. The need for postoperative catheterization is generally based on arbitrarily determined ratios of voided urine to PVR. The force of stream trial (FAST) does not prioritize amount voided, but rather the patient's subjective force of stream. Using FAST, a patient uses a visual analog scale (VAS) scale to quantify her force of stream. If she states that her Force of Stream (FOS) is \>50% of her baseline prior to surgery, independent of the amount voided, she is discharged without a catheter. If the FOS is \<50%, a PVR is measured via bladder scan. If her PVR is \<500cc the patient is discharged home.

No randomized control trials (RCT) have been performed comparing the FAST method to the traditional retrograde voiding trial in subjects undergoing vaginal apex prolapse surgery despite the promising findings that FAST voiding trials are as reliable and safe as retrograde voiding trials in patients undergoing anti-incontinence surgeries. Standard in our practice is to perform a voiding trial on postoperative day 1 on all patients after vaginal apical prolapse surgery if they are to be discharged without a catheter. Investigators would like to compare the FAST voiding trial to a traditional retrograde fill voiding trial with respect to the rate of catheterization among those discharged without a catheter within the six-week postoperative period in patients undergoing a vaginal apex prolapse surgery. Investigators hypothesize the FAST voiding trial method is not inferior to traditional retrograde voiding trial. Subjects will complete questionnaires to examine postoperative bladder function, symptom distress and quality of life before and after surgery during their routine postoperative visits.

Eligibility criteria: Inclusion Criteria:

1. Women undergoing vaginal apex surgery (sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, colpocleisis) with or without mid-urethral sling, with or without anterior or posterior colporrhaphy

Exclusion Criteria:

1. Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum)
2. Patients who sustained a cystotomy during surgery as our divisional protocol is to send these patients home with a Foley catheter for 5-14 days without a voiding trial
3. Patients with baseline urinary retention and the inability to urinate without catheterization
4. Pregnant women

Primary outcomes:
measure: Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter.
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial)
timeFrame: 6 weeks
measure: Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Northwell Health System Division of Urogynecology
state: New York
Study officials:
References:
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