Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension

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Northwell Health

Status

Completed

Conditions

Vaginal Apical Prolapse

Treatments

Device: Foley catheter
Other: voiding trial

Study type

Interventional

Funder types

Other

Identifiers

NCT02753920
HS16-0232

Details and patient eligibility

About

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.

Full 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.

Enrollment

184 patients

Sex

Female

Ages

18 to 95 years old

Volunteers

Accepts Healthy Volunteers

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

  • Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum)
  • 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
  • Patients with baseline urinary retention and the inability to urinate without catheterization
  • Pregnant women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

184 participants in 2 patient groups

Retrograde fill voiding trial method
Active Comparator group
Description:
Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter is removed Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). The patient will subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids >/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids <200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.
Treatment:
Device: Foley catheter
Other: voiding trial
Force of Stream (FAST) voiding trial method
Active Comparator group
Description:
Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter is removed Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). The patient will subjectively quantify their force of stream via VAS scale. If VAS scale >/=50 (>/=50%) the catheter will remain out, patient is discharged home without measuring a PVR If VAS scale is from 0-49 (=0-49%) a PVR will be checked via bladder scan. If PVR is <500cc, the patient will be discharged without a catheter; if PVR is >/=500cc, the patient will be discharged with a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days.
Treatment:
Device: Foley catheter
Other: voiding trial

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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