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

November 17, 2016 updated by: Amy L O'Boyle, National Naval Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Parallel Assignment design study. The PFDI-20 symptom questionnaire was completed upon enrollment. After the patient was prepped and draped, the operating room nurse opened a sealed opaque envelope marked with the study subject number containing a card marked with the assignment to bladder flap or no bladder flap, which was shown to the surgeons prior to the skin incision. The patient did not see the allocation nor was it verbalized in the operating room. The PFDI-20 was repeated 6-8 weeks after delivery at the patient's postpartum exam clinic visit. Equal number of bladder flap and no bladder flap assignment cards were randomly shuffled and placed in envelopes marked with the study subject ID number prior to the start of the study.

The study hypothesis was that the omission of the bladder flap at the time of primary cesarean delivery would be associated with lower urinary symptoms scores in the postpartum as measured by the UDI-6 component of the PFDI-20.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant at 37 weeks gestation or greater
  • scheduled for a non-urgent primary cesarean delivery

Exclusion Criteria:

  • pre-term (defined as less than 37 weeks 0 days gestation) prior pelvic surgery involving the bladder
  • a diagnosis of any of the following conditions: endometriosis, uterine leiomyomata, chronic pelvic pain, urinary incontinence prior to pregnancy, nephrolithiasis during the current pregnancy,
  • any circumstance that precluded adequate informed consent at the time of recruitment (such as a need to for urgent or emergent delivery)
  • if the indication for cesarean was a failed trial of operative vaginal delivery (forceps or vacuum extraction)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bladder flap performed as per routine
Bladder flap surgical step performed at time of non-urgent primary cesarean delivery as per routine
Procedure: Bladder flap
bladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery
Other Names:
  • Dissection of the vesicouterine fold
No Intervention: Bladder flap is omitted
No bladder flap performed at time of non-urgent primary cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in urinary symptoms between study groups at 2 months postpartum
Time Frame: The difference in urinary symptoms between study groups at 2 months postpartum
The difference in the urinary symptoms measured using the UDI-6 questionnaire at 2 months postpartum between study groups (bladder flap vs no bladder flap at time of primary cesarean delivery)
The difference in urinary symptoms between study groups at 2 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pelvic floor symptoms prior to delivery and at 2 months postpartum
Time Frame: During pregnancy and 2 months postpartum
Change in the PFDI-20 and each sub scale before and after delivery
During pregnancy and 2 months postpartum

Collaborators and Investigators

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

Sponsor

National Naval Medical Center

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

May 1, 2007

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007.0005

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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