CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Bladder flapprocedure
Likely dose
Not stated in record
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Search/NCT02967913
NCT02967913N/ACompleted

Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery

National Naval Medical Center·interventional·Posted Nov 18, 2016·Updated Nov 21, 2016

In Brief

A clinical study evaluating Bladder flap for Pelvic Floor Disorders. Completed, enrolled 70 participants.

Detailed Summary

The bladder flap at the time of cesarean delivery is the term used to describe the separation of the bladder from the lower uterine segment by sharply incising the vesico-uterine peritoneum or serosa and using blunt and/or sharp dissection to develop this potential space which facilitates placement of a retractor, known as the bladder blade. Creating a bladder flap at the time of cesarean delivery is largely based on individual practice patterns and practitioners are divided in their use of this step. While creating a bladder flap has a theoretical advantage of protecting the bladder from injury, it is unknown whether this step has an effect on postoperative bladder function. The purpose of this study was to evaluate whether the omission or creation of a bladder flap results in a change in urinary symptoms as measured by the UDI-6 component of the PFDI-20.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 18, 2016
Enrollment StartMay 1, 2007
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 9.6 years ago

Interventions

Bladder flapprocedure

bladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery