Vaginal Apical Prolapse Clinical Trial
Official title:
A Randomized, Controlled Trial After Vaginal Apex Suspension Comparing Force of Stream to Traditional Retrograde Fill Voiding Trial
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.
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.
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