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

NCT02967913 | Completed

• 1 other identifier: 2007.0005
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Floor Disorders

Keywords

Cesarean delivery; Obstetrical delivery; PFDI-20; UDI-6; Bladder flap

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in pelvic floor symptoms prior to delivery and at 2 months postpartum

  During pregnancy and 2 months postpartum

Study Arms (2)

Bladder flap performed as per routine

EXPERIMENTAL

Bladder flap surgical step performed at time of non-urgent primary cesarean delivery as per routine

Procedure: Bladder flap

Bladder flap is omitted

NO INTERVENTION

No bladder flap performed at time of non-urgent primary cesarean delivery

Interventions

Bladder flap PROCEDURE

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

Also known as: Dissection of the vesicouterine fold

Bladder flap performed as per routine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Naval Medical Center: lead

Related Publications (14)

• Klein MC. Cesarean section on maternal request: a societal and professional failure and symptom of a much larger problem. Birth. 2012 Dec;39(4):305-10. doi: 10.1111/birt.12006. Epub 2012 Nov 5.

  PMID: 23281950 BACKGROUND

• 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.

  PMID: 12621134 BACKGROUND

• 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.

  PMID: 11755545 BACKGROUND

• 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.

  PMID: 16628375 BACKGROUND

• 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.

  PMID: 23436034 BACKGROUND

• 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.

  PMID: 11755558 BACKGROUND

• 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.

  PMID: 16260200 BACKGROUND

• 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.

  PMID: 22395144 BACKGROUND

• Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.

  PMID: 23467047 BACKGROUND

• Jozwik M, Jozwik M, Lotocki W, Mironczuk J. Dysuria due to bladder distortion after repeat cesarean section. Gynecol Obstet Invest. 1998;45(4):279-80. doi: 10.1159/000009985.

  PMID: 9623798 BACKGROUND

• Tinelli A, Malvasi A, Vittori G. Laparoscopic treatment of post-cesarean section bladder flap hematoma: A feasible and safe approach. Minim Invasive Ther Allied Technol. 2009;18(6):356-60. doi: 10.3109/13645700903201357.

  PMID: 19929298 BACKGROUND

• Handa VL, Blomquist JL, Knoepp LR, Hoskey KA, McDermott KC, Munoz A. Pelvic floor disorders 5-10 years after vaginal or cesarean childbirth. Obstet Gynecol. 2011 Oct;118(4):777-84. doi: 10.1097/AOG.0b013e3182267f2f.

  PMID: 21897313 BACKGROUND

• Boyles SH, Li H, Mori T, Osterweil P, Guise JM. Effect of mode of delivery on the incidence of urinary incontinence in primiparous women. Obstet Gynecol. 2009 Jan;113(1):134-141. doi: 10.1097/AOG.0b013e318191bb37.

  PMID: 19104369 BACKGROUND

• Blaivas JG, Panagopoulos G, Weiss JP, Somaroo C. Validation of the overactive bladder symptom score. J Urol. 2007 Aug;178(2):543-7; discussion 547. doi: 10.1016/j.juro.2007.03.133. Epub 2007 Jun 14.

  PMID: 17570417 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Female Pelvic Medicine & Reconstructive Surgeon

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 18, 2016
• Study Start: May 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 21, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share