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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.

Sponsor: National Naval Medical Center

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in pelvic floor symptoms prior to delivery and at 2 months postpartum [ Time Frame: During pregnancy and 2 months postpartum ]

Original Secondary Outcome: Same as current

Information By: National Naval Medical Center

Dates:
Date Received: November 7, 2016
Date Started: May 2007
Date Completion:
Last Updated: November 17, 2016
Last Verified: November 2016