Pelvic Floor DisordersNCT02967913
Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery
A study testing Bladder flap in people with Pelvic Floor Disorders, run by National Naval Medical Center.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Bladder flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant at 37 weeks gestation or greater
- scheduled for a non-urgent primary cesarean delivery
Who cannot join
- 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)
About this study
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.
Read the 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Bladder flap
- Keywords
- Cesarean delivery, Obstetrical delivery, PFDI-20, UDI-6, Bladder flap
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder flapProcedure or surgery
Also called Dissection of the vesicouterine fold
bladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Bladder flap performed as per routine | Experimental | Bladder flap surgical step performed at time of non-urgent primary cesarean delivery as per routine Receives: Procedure: Bladder flap |
| Bladder flap is omitted | No intervention | No bladder flap performed at time of non-urgent primary cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Change in the PFDI-20 and each sub scale before and after delivery
Measured: During pregnancy and 2 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startMay 2007
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Naval Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Amy L O'Boyle, National Naval Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967913
- Sponsor's protocol ID
- 2007.0005
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23281950Rortveit 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.
PubMed 12621134Rortveit 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.
PubMed 11755545van 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.
PubMed 16628375Wesnes 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.
PubMed 23436034Hohlagschwandtner 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.
PubMed 11755558Berghella 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.
PubMed 16260200Tuuli 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.
PubMed 22395144Dahlke 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.
PubMed 23467047Jozwik 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.
PubMed 9623798Tinelli 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.
PubMed 19929298Handa 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.
PubMed 21897313Boyles 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.
PubMed 19104369Blaivas 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.
PubMed 17570417
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02967913
- Acronym / sponsor ID
- 2007.0005
- Conditions
- Pelvic Floor Disorders
- Keywords
- Cesarean delivery, Obstetrical delivery, PFDI-20, UDI-6, Bladder flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Naval Medical CenterUS federal agency
- Study start
- May 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder flap performed as per routine | Experimental | Procedure: Bladder flapBladder flap surgical step performed at time of non-urgent primary cesarean delivery as per routine |
| Bladder flap is omitted | No intervention | –No bladder flap performed at time of non-urgent primary cesarean delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pregnant at 37 weeks gestation or greater
- scheduled for a non-urgent primary cesarean delivery
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder flapAlso: Dissection of the vesicouterine foldbladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery | Procedure or surgery | Bladder flap performed as per routine |
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
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)
1 secondary outcome
Change in pelvic floor symptoms prior to delivery and at 2 months postpartum
Time frame: During pregnancy and 2 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Background: PubMed 23281950Klein 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.
- Background: PubMed 12621134Rortveit 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.
- Background: PubMed 11755545Rortveit 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.
- Background: PubMed 16628375van 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.
- Background: PubMed 23436034Wesnes 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.
- Background: PubMed 11755558Hohlagschwandtner 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.
- Background: PubMed 16260200Berghella 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.
- Background: PubMed 22395144Tuuli 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.
- Background: PubMed 23467047Dahlke 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.
- Background: PubMed 9623798Jozwik 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.
- Background: PubMed 19929298Tinelli 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.
- Background: PubMed 21897313Handa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder flap in people with Pelvic Floor Disorders, run by National Naval Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967913, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.