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

November 2, 2018 updated by: Harvey Winkler, Northwell Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health System Division of Urogynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Retrograde fill voiding trial method
  1. Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water.
  2. Catheter is removed
  3. Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction).
  4. 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).
  5. 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.
Other: voiding trial
1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling
Device: Foley catheter
If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. The subject will follow up in the office for removal of catheter.
Active Comparator: Force of Stream (FAST) voiding trial method
  1. Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water.
  2. Catheter is removed
  3. Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction).
  4. The patient will subjectively quantify their force of stream via VAS scale.
  5. If VAS scale >/=50 (>/=50%) the catheter will remain out, patient is discharged home without measuring a PVR
  6. 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.
Other: voiding trial
1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling
Device: Foley catheter
If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. The subject will follow up in the office for removal of catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial)
Time Frame: 6 weeks
6 weeks
Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS16-0232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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