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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967913
• Other study ID #: 2007.0005
• Status: Completed
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 17, 2016
• Start date: May 2007
• Est. completion date: February 2013

Study information

• Verified date: November 2016
• Source: National Naval Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Procedure:
• Bladder flap
bladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Naval Medical Center

References & Publications (14)

Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. Review. — View Citation

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. — View Citation

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):134-41. doi: 10.1097/AOG.0b013e318191bb37. — View Citation

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. Review. — View Citation

Handa VL, Blomquist JL, Knoepp LR, Hoskey KA, McDermott KC, Muñoz 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. — View 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. — View Citation

Józwik M, Józwik M, Lotocki W, Mironczuk J. Dysuria due to bladder distortion after repeat cesarean section. Gynecol Obstet Invest. 1998;45(4):279-80. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	During pregnancy and 2 months postpartum	No