Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery
Primary Purpose
Pelvic Floor Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bladder flap
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Floor Disorders focused on measuring Cesarean delivery, Obstetrical delivery, PFDI-20, UDI-6, Bladder flap
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bladder flap performed as per routine
Bladder flap is omitted
Arm Description
Bladder flap surgical step performed at time of non-urgent primary cesarean delivery as per routine
No bladder flap performed at time of non-urgent primary cesarean delivery
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change in pelvic floor symptoms prior to delivery and at 2 months postpartum
Change in the PFDI-20 and each sub scale before and after delivery
Full Information
NCT ID
NCT02967913
First Posted
November 7, 2016
Last Updated
November 17, 2016
Sponsor
National Naval Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02967913
Brief Title
Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery
Official Title
Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Naval Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Cesarean delivery, Obstetrical delivery, PFDI-20, UDI-6, Bladder flap
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bladder flap performed as per routine
Arm Type
Experimental
Arm Description
Bladder flap surgical step performed at time of non-urgent primary cesarean delivery as per routine
Arm Title
Bladder flap is omitted
Arm Type
No Intervention
Arm Description
No bladder flap performed at time of non-urgent primary cesarean delivery
Intervention Type
Procedure
Intervention Name(s)
Bladder flap
Other Intervention Name(s)
Dissection of the vesicouterine fold
Intervention Description
bladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery
Primary Outcome Measure Information:
Title
The difference in urinary symptoms between study groups at 2 months postpartum
Description
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)
Time Frame
The difference in urinary symptoms between study groups at 2 months postpartum
Secondary Outcome Measure Information:
Title
Change in pelvic floor symptoms prior to delivery and at 2 months postpartum
Description
Change in the PFDI-20 and each sub scale before and after delivery
Time Frame
During pregnancy and 2 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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23281950
Citation
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Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery
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