Vesicovaginal FistulaNCT03236922
Autologous Slings With Vesico-Vaginal Fistula Repair
A study testing Pubococcygeus sling and Rectus fascia sling in people with Vesicovaginal Fistula, run by Baylor College of Medicine at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vesicovaginal Fistula
- What is being tested?
- Pubococcygeus sling and Rectus fascia sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteMalawi
- Study dates
- Jun 2016to Aug 2019
- 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 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pubococcygeus Versus Rectus Sheath Sling for Goh Class 3 and 4 Vesico-vaginal Fistulas: a Randomized Controlled Trial
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.
- Conditions
- Vesicovaginal Fistula
- Being tested
- Pubococcygeus sling, Rectus fascia sling
- Keywords
- obstetric fistula, anti-incontinence techniques
- Medical subject headings
- Vesicovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pubococcygeus slingProcedure or surgery
Also called pubococcygeal sling, pubococcygeus graft
The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.
Rectus fascia slingProcedure or surgery
Also called rectus fascia graft
Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.
| Study group | Role | What they receive |
|---|---|---|
| Pubococcygeus Sling | Active comparator | This is one anti-incontinence technique commonly used at the time of fistula surgery. Receives: Procedure: Pubococcygeus sling |
| Rectus Fascia Sling | Active comparator | This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus. Receives: Procedure: Rectus fascia sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months after surgery
Secondary outcomes (1)
Vesico-vaginal fistula repaired
To ensure the VVF is still closed and was not compromised due to the sling
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study startJun 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vesicovaginal FistulaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Wilkinson, Baylor College of Medicine
- Investigators
- Rachel Pope, MD, MPH, Study director, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236922
- Sponsor's protocol ID
- H-38672
- Status last verified
- Jul 2017
- First submitted
- 21 Aug 2016
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: No.
Publications
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.
PubMed 20556597Browning 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.
PubMed 16489933Browning 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.
PubMed 15008773Carey 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.
PubMed 12015520Pope 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.
PubMed 31145227
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pubococcygeus Versus Rectus Sheath Sling for Goh Class 3 and 4 Vesico-vaginal Fistulas: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03236922
- Acronym / sponsor ID
- H-38672
- Conditions
- Vesicovaginal Fistula
- Keywords
- obstetric fistula, anti-incontinence techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 2 Aug 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pubococcygeus Sling | Active comparator | Procedure: Pubococcygeus slingThis is one anti-incontinence technique commonly used at the time of fistula surgery. |
| Rectus Fascia Sling | Active comparator | Procedure: Rectus fascia slingThis is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Pubococcygeus slingAlso: pubococcygeal sling, pubococcygeus graftThe pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra. | Procedure or surgery | Pubococcygeus Sling |
| Rectus fascia slingAlso: rectus fascia graftRectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra. | Procedure or surgery | Rectus Fascia Sling |
Primary outcome
Long-term Continence Status
Time frame: Six months after surgery
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.
1 secondary outcome
Vesico-vaginal fistula repaired
Time frame: One month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Background: PubMed 20556597Ascher-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 publication: PubMed 16489933Browning 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 publication: PubMed 15008773Browning 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 publication: PubMed 12015520Carey 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.
- Derived from this study: PubMed 31145227Pope 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.
- Individual participant dataSharing planned: Yes. No.
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.
Rachel Pope, MD, MPH study director
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pubococcygeus sling and Rectus fascia sling in people with Vesicovaginal Fistula, run by Baylor College of Medicine at 1 site in Malawi.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Long-term Continence Status (time frame: Six months after surgery). 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 NCT03236922, which also lists 5 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 2 Aug 2017.