<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02967913</url>
  </required_header>
  <id_info>
    <org_study_id>2007.0005</org_study_id>
    <nct_id>NCT02967913</nct_id>
  </id_info>
  <brief_title>Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery</brief_title>
  <official_title>Urinary Symptoms and the Omission of the Bladder Flap at the Time of Primary Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Naval Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Naval Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The bladder flap at the time of cesarean delivery is the term used to describe the separation&#xD;
      of the bladder from the lower uterine segment by sharply incising the vesico-uterine&#xD;
      peritoneum or serosa and using blunt and/or sharp dissection to develop this potential space&#xD;
      which facilitates placement of a retractor, known as the bladder blade. Creating a bladder&#xD;
      flap at the time of cesarean delivery is largely based on individual practice patterns and&#xD;
      practitioners are divided in their use of this step. While creating a bladder flap has a&#xD;
      theoretical advantage of protecting the bladder from injury, it is unknown whether this step&#xD;
      has an effect on postoperative bladder function. The purpose of this study was to evaluate&#xD;
      whether the omission or creation of a bladder flap results in a change in urinary symptoms as&#xD;
      measured by the UDI-6 component of the PFDI-20.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Parallel Assignment design study. The PFDI-20 symptom questionnaire was completed&#xD;
      upon enrollment. After the patient was prepped and draped, the operating room nurse opened a&#xD;
      sealed opaque envelope marked with the study subject number containing a card marked with the&#xD;
      assignment to bladder flap or no bladder flap, which was shown to the surgeons prior to the&#xD;
      skin incision. The patient did not see the allocation nor was it verbalized in the operating&#xD;
      room. The PFDI-20 was repeated 6-8 weeks after delivery at the patient's postpartum exam&#xD;
      clinic visit. Equal number of bladder flap and no bladder flap assignment cards were randomly&#xD;
      shuffled and placed in envelopes marked with the study subject ID number prior to the start&#xD;
      of the study.&#xD;
&#xD;
      The study hypothesis was that the omission of the bladder flap at the time of primary&#xD;
      cesarean delivery would be associated with lower urinary symptoms scores in the postpartum as&#xD;
      measured by the UDI-6 component of the PFDI-20.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in urinary symptoms between study groups at 2 months postpartum</measure>
    <time_frame>The difference in urinary symptoms between study groups at 2 months postpartum</time_frame>
    <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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pelvic floor symptoms prior to delivery and at 2 months postpartum</measure>
    <time_frame>During pregnancy and 2 months postpartum</time_frame>
    <description>Change in the PFDI-20 and each sub scale before and after delivery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Pelvic Floor Disorders</condition>
  <arm_group>
    <arm_group_label>Bladder flap performed as per routine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bladder flap surgical step performed at time of non-urgent primary cesarean delivery as per routine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bladder flap is omitted</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No bladder flap performed at time of non-urgent primary cesarean delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bladder flap</intervention_name>
    <description>bladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery</description>
    <arm_group_label>Bladder flap performed as per routine</arm_group_label>
    <other_name>Dissection of the vesicouterine fold</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant at 37 weeks gestation or greater&#xD;
&#xD;
          -  scheduled for a non-urgent primary cesarean delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre-term (defined as less than 37 weeks 0 days gestation) prior pelvic surgery&#xD;
             involving the bladder&#xD;
&#xD;
          -  a diagnosis of any of the following conditions: endometriosis, uterine leiomyomata,&#xD;
             chronic pelvic pain, urinary incontinence prior to pregnancy, nephrolithiasis during&#xD;
             the current pregnancy,&#xD;
&#xD;
          -  any circumstance that precluded adequate informed consent at the time of recruitment&#xD;
             (such as a need to for urgent or emergent delivery)&#xD;
&#xD;
          -  if the indication for cesarean was a failed trial of operative vaginal delivery&#xD;
             (forceps or vacuum extraction)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <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. Epub 2012 Nov 5.</citation>
    <PMID>23281950</PMID>
  </reference>
  <reference>
    <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. doi: 10.1056/NEJMoa021788.</citation>
    <PMID>12621134</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11755545</PMID>
  </reference>
  <reference>
    <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. doi: 10.1007/s00192-006-0119-5. Epub 2006 Apr 21.</citation>
    <PMID>16628375</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23436034</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11755558</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16260200</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22395144</PMID>
  </reference>
  <reference>
    <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. Epub 2013 Mar 1.</citation>
    <PMID>23467047</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9623798</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19929298</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21897313</PMID>
  </reference>
  <reference>
    <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):134-141. doi: 10.1097/AOG.0b013e318191bb37.</citation>
    <PMID>19104369</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/j.juro.2007.03.133. Epub 2007 Jun 14.</citation>
    <PMID>17570417</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Naval Medical Center</investigator_affiliation>
    <investigator_full_name>Amy L O'Boyle</investigator_full_name>
    <investigator_title>Staff Female Pelvic Medicine &amp; Reconstructive Surgeon</investigator_title>
  </responsible_party>
  <keyword>Cesarean delivery</keyword>
  <keyword>Obstetrical delivery</keyword>
  <keyword>PFDI-20</keyword>
  <keyword>UDI-6</keyword>
  <keyword>Bladder flap</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Floor Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02967913
org study id: 2007.0005
nct id: NCT02967913
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
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
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)
measure: Change in pelvic floor symptoms prior to delivery and at 2 months postpartum
time frame: During pregnancy and 2 months postpartum
description: Change in the PFDI-20 and each sub scale before and after delivery
arm group label: Bladder flap performed as per routine
arm group type: Experimental
description: Bladder flap surgical step performed at time of non-urgent primary cesarean delivery as per routine
arm group label: Bladder flap is omitted
arm group type: No Intervention
description: No bladder flap performed at time of non-urgent primary cesarean delivery
intervention type: Procedure
intervention name: Bladder flap
description: bladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery
arm group label: Bladder flap performed as per routine
other name: Dissection of the vesicouterine fold
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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. Epub 2012 Nov 5.
PMID: 23281950
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. doi: 10.1056/NEJMoa021788.
PMID: 12621134
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.
PMID: 11755545
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. doi: 10.1007/s00192-006-0119-5. Epub 2006 Apr 21.
PMID: 16628375
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.
PMID: 23436034
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.
PMID: 11755558
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.
PMID: 16260200
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.
PMID: 22395144
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. Epub 2013 Mar 1.
PMID: 23467047
citation: 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
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.
PMID: 19929298
citation: 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
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):134-141. doi: 10.1097/AOG.0b013e318191bb37.
PMID: 19104369
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. doi: 10.1016/j.juro.2007.03.133. Epub 2007 Jun 14.
PMID: 17570417
responsible party type: Principal Investigator
investigator affiliation: National Naval Medical Center
investigator full name: Amy L O'Boyle
investigator title: Staff Female Pelvic Medicine & Reconstructive Surgeon
mesh term: Pelvic Floor Disorders
sharing ipd: No