Autologous Slings With Vesico-Vaginal Fistula Repair
Primary Purpose
Vesicovaginal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Pubococcygeus sling
Rectus fascia sling
Sponsored by
About this trial
This is an interventional prevention trial for Vesicovaginal Fistula focused on measuring obstetric fistula, anti-incontinence techniques
Eligibility Criteria
Inclusion Criteria:
- Women with vesico-vaginal fistulas classified as Goh 3 or 4 at the time of surgery
- Patients who have consented for an autologous sling
- Patients who have not previously undergone repair attempt
Exclusion Criteria:
- Patients who require an abdominal approach to the VVF repair
- Patients found at surgery not to have a Goh 3 or 4 class VVF
- Patients requiring a complete urethral reconstruction
- Patients who have undergone previous attempt at repair
- Patients who require an alternative tissue grafting other than the rectus fascia or pubbococcygeus decided by the surgeon at the time of surgery
Sites / Locations
- Fistula Care Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pubococcygeus Sling
Rectus Fascia Sling
Arm Description
This is one anti-incontinence technique commonly used at the time of fistula surgery.
This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.
Outcomes
Primary Outcome Measures
Long-term Continence Status
Residual stress incontinence is commonly experienced by this patient population, therefore a dye test to ensure the fistula is still closed and a cough test to determine any incontinence will be performed.
Secondary Outcome Measures
Vesico-vaginal fistula repaired
To ensure the VVF is still closed and was not compromised due to the sling
Full Information
NCT ID
NCT03236922
First Posted
August 21, 2016
Last Updated
July 29, 2017
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03236922
Brief Title
Autologous Slings With Vesico-Vaginal Fistula Repair
Official Title
Pubococcygeus Versus Rectus Sheath Sling for Goh Class 3 and 4 Vesico-vaginal Fistulas: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is clear from multiple accounts in the literature that patients with a vesico-vaginal fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of residual incontinence. Performing subsequent surgeries after the initial VVF repair risks additional complications. Therefore, placement of an autologous sling at the time of initial VVF repair would not only assist in covering the fistula, but would also imitate the physiologic support that would theoretically improve urethral function. A rectus fascia sling would most naturally provide this support and warrants testing against the success of the PC sling.
Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the urethra. Therefore, this group of patients is the target population for this study. As there is currently no standard of care for repairing large urethral defects, this procedural technique combined with otherwise standardized fistula repair would not introduce any foreseeable harm to patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesicovaginal Fistula
Keywords
obstetric fistula, anti-incontinence techniques
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pubococcygeus Sling
Arm Type
Active Comparator
Arm Description
This is one anti-incontinence technique commonly used at the time of fistula surgery.
Arm Title
Rectus Fascia Sling
Arm Type
Active Comparator
Arm Description
This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.
Intervention Type
Procedure
Intervention Name(s)
Pubococcygeus sling
Other Intervention Name(s)
pubococcygeal sling, pubococcygeus graft
Intervention Description
The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.
Intervention Type
Procedure
Intervention Name(s)
Rectus fascia sling
Other Intervention Name(s)
rectus fascia graft
Intervention Description
Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.
Primary Outcome Measure Information:
Title
Long-term Continence Status
Description
Residual stress incontinence is commonly experienced by this patient population, therefore a dye test to ensure the fistula is still closed and a cough test to determine any incontinence will be performed.
Time Frame
Six months after surgery
Secondary Outcome Measure Information:
Title
Vesico-vaginal fistula repaired
Description
To ensure the VVF is still closed and was not compromised due to the sling
Time Frame
One month after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women with vesico-vaginal fistulas classified as Goh 3 or 4 at the time of surgery
Patients who have consented for an autologous sling
Patients who have not previously undergone repair attempt
Exclusion Criteria:
Patients who require an abdominal approach to the VVF repair
Patients found at surgery not to have a Goh 3 or 4 class VVF
Patients requiring a complete urethral reconstruction
Patients who have undergone previous attempt at repair
Patients who require an alternative tissue grafting other than the rectus fascia or pubbococcygeus decided by the surgeon at the time of surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Pope, MD, MPH
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Fistula Care Center
City
Lilongwe
Country
Malawi
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
No.
Citations:
PubMed Identifier
20556597
Citation
Ascher-Walsh CJ, Capes TL, Lo Y, Idrissa A, Wilkinson J, Echols K, Crawford B, Genadry R. Sling procedures after repair of obstetric vesicovaginal fistula in Niamey, Niger. Int Urogynecol J. 2010 Nov;21(11):1385-90. doi: 10.1007/s00192-010-1202-5. Epub 2010 Jun 17.
Results Reference
background
PubMed Identifier
16489933
Citation
Browning A. Risk factors for developing residual urinary incontinence after obstetric fistula repair. BJOG. 2006 Apr;113(4):482-5. doi: 10.1111/j.1471-0528.2006.00875.x. Epub 2006 Feb 20.
Results Reference
result
PubMed Identifier
15008773
Citation
Browning A. Prevention of residual urinary incontinence following successful repair of obstetric vesico-vaginal fistula using a fibro-muscular sling. BJOG. 2004 Apr;111(4):357-61. doi: 10.1111/j.1471-0528.2004.00080.x.
Results Reference
result
PubMed Identifier
12015520
Citation
Carey MP, Goh JT, Fynes MM, Murray CJ. Stress urinary incontinence after delayed primary closure of genitourinary fistula: a technique for surgical management. Am J Obstet Gynecol. 2002 May;186(5):948-53. doi: 10.1067/mob.2002.122247.
Results Reference
result
PubMed Identifier
31145227
Citation
Pope R, Browning A, Chipungu E, George JOM, Tamimu M, Wilkinson J. Prophylactic Autologous Slings at the Time of Obstetric Fistula Repair: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):78-84. doi: 10.1097/SPV.0000000000000745.
Results Reference
derived
Learn more about this trial
Autologous Slings With Vesico-Vaginal Fistula Repair
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