CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 184 enrolled
Drug / intervention
voiding trial +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02753920
NCT02753920N/ACompleted
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A Randomized, Controlled Trial After Vaginal Apex Suspension Comparing Force of Stream to Traditional Retrograde Fill Voiding Trial

Northwell Health·interventional·Posted Apr 28, 2016·Updated Nov 5, 2018

In Brief

A clinical study evaluating voiding trial and Foley catheter for Vaginal Apical Prolapse. Completed, enrolled 184 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Apical Prolapse
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 28, 2016
Enrollment StartMar 1, 2016
Primary CompletionJun 1, 2017
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.2 years ago

Interventions

voiding trialother

1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling

Foley catheterdevice

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.