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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
National Naval Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    November 7, 2016
    Last Updated
    November 17, 2016
    Sponsor
    National Naval Medical Center
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    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:
    PubMed Identifier
    23281950
    Citation
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    Rortveit G, Daltveit AK, Hannestad YS, Hunskaar S; Norwegian EPINCONT Study. Urinary incontinence after vaginal delivery or cesarean section. N Engl J Med. 2003 Mar 6;348(10):900-7. doi: 10.1056/NEJMoa021788.
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    Citation
    Rortveit G, Hannestad YS, Daltveit AK, Hunskaar S. Age- and type-dependent effects of parity on urinary incontinence: the Norwegian EPINCONT study. Obstet Gynecol. 2001 Dec;98(6):1004-10. doi: 10.1016/s0029-7844(01)01566-6.
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    van Brummen HJ, Bruinse HW, van de Pol G, Heintz AP, van der Vaart CH. The effect of vaginal and cesarean delivery on lower urinary tract symptoms: what makes the difference? Int Urogynecol J Pelvic Floor Dysfunct. 2007 Feb;18(2):133-9. doi: 10.1007/s00192-006-0119-5. Epub 2006 Apr 21.
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    Citation
    Wesnes SL, Lose G. Preventing urinary incontinence during pregnancy and postpartum: a review. Int Urogynecol J. 2013 Jun;24(6):889-99. doi: 10.1007/s00192-012-2017-3. Epub 2013 Feb 23.
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    PubMed Identifier
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    Citation
    Hohlagschwandtner M, Ruecklinger E, Husslein P, Joura EA. Is the formation of a bladder flap at cesarean necessary? A randomized trial. Obstet Gynecol. 2001 Dec;98(6):1089-92. doi: 10.1016/s0029-7844(01)01570-8.
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    Citation
    Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
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    Tuuli MG, Odibo AO, Fogertey P, Roehl K, Stamilio D, Macones GA. Utility of the bladder flap at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2012 Apr;119(4):815-21. doi: 10.1097/AOG.0b013e31824c0e12.
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    Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery

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