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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pubococcygeus Sling | Active Comparator | This is one anti-incontinence technique commonly used at the time of fistula surgery. |
|
| Rectus Fascia Sling | Active Comparator | This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pubococcygeus sling | Procedure | The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Vesico-vaginal fistula repaired | To ensure the VVF is still closed and was not compromised due to the sling | One month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Pope, MD, MPH | Baylor College of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fistula Care Center | Lilongwe | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20556597 | Background | 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. | |
| 16489933 | Result | 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. |
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No.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2020 | |
| Reset | Mar 18, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2020 | Mar 18, 2020 |
| ID | Term |
|---|---|
| D014719 | Vesicovaginal Fistula |
| ID | Term |
|---|---|
| D014624 | Vaginal Fistula |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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|
| Rectus fascia sling | Procedure | Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra. |
|
|
| 15008773 | Result | 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. |
| 12015520 | Result | 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. |
| 31145227 | Derived | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001747 | Urinary Bladder Fistula |
| D014548 | Urinary Fistula |
| D014564 | Urogenital Abnormalities |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D000091662 | Genital Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |