Female Genital FistulaMulisaNCT05437939
Adverse Outcomes Following Female Genital Fistula Repair
An observational study of Female Genital Fistula and Incontinence, run by University of California, San Francisco at 1 site in Uganda.
Trial summary
Following genital fistula repair, fistula repair breakdown and recurrence, persistent and incidence incontinence are major adverse outcomes, limiting women's health and wellbeing. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Female Genital Fistula, Incontinence
- How many people
- 802 participants
- Where
- 1 siteUganda
- Study dates
- 20 May 2022to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to n=1000 women with successful (closed) vesicovaginal fistula repair who are 18 and older or 15-17 year old emancipated minors (per Ugandan law) will be eligible to participate from fistula surgery centers and hospitals participating in the study as recruitment sites.
Who may be able to join
- Vesicovaginal fistula
- Completed surgery with confirmed surgical closure
- Age 15 or above, with ages 15-17 meeting criteria for emancipated minor
- Capable of providing informed consent
Who cannot join
- None beyond above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital
Following genital fistula repair, fistula repair breakdown and recurrence, persistent and incidence incontinence are major adverse outcomes, limiting women's health and wellbeing. Using a prospective design, the investigators seek to identify modifiable risk factors to establish key targets for intervention, followed by qualitative work to refine the feasibility and acceptability of potential intervention strategies.
Read the detailed description
Although improved global surgical access has begun to reduce the significant physical, psychosocial, and economic consequences of fistula, women with successful surgery face adverse post-repair risks. Emerging research has identified post-repair fistula recurrence in up to 14% of women following surgery, with many recurrences occurring within the first 12 months. Post-repair incontinence continues in up to 33% of women despite closed fistula, with some women developing incident incontinence after previously successful resolution through fistula surgery. However, the limited evidence base on factors contributing to adverse outcomes limits interventions to improve women's health and quality of life following genital fistula repair.
The investigators hypothesize that important independent predictors of vesicovaginal fistula repair breakdown and recurrence will include indications of fistula severity, strenuous labor, early resumption of sexual intercourse and subsequent pregnancy. Further modifiable characteristics whose potential contribution the investigators seek to establish for these adverse outcomes include other post-repair behaviors and exposures. To test these hypotheses and explore additional contributors to adverse outcomes, the investigators will leverage the research infrastructure the investigators have developed at several fistula repair sites in Uganda to lead a 3-year longitudinal cohort study of up to 1000 women following genital fistula repair. The investigators will collect data on sociodemographic characteristics, fistula and repair-related characteristics at fistula repair, and data on post-repair behaviors and exposures quarterly. If participants report key symptoms (recurrence and incontinence), the investigators will confirm these outcomes by clinical validation through physical examination. The investigators will calculate incidence and establish temporal relationships of a range of exposures with adverse outcomes to identify key targets for intervention. The investigators will then engage key stakeholders in iterative qualitative work framed by key behavioral and implementation science theories to enhance translation of our quantitative findings into intervention strategies that are feasible and acceptable in this context. This mixed-methods work has a strong potential to directly influence programming to reduce adverse outcomes following genital fistula repair.
Aim 1: Identify predictors of post-repair fistula breakdown and recurrence. The investigators will use survival analysis methods to compare baseline and time-varying patient characteristics of women in our longitudinal cohort who develop post-repair fistula breakdown and recurrence compared to those who do not. Assessment will focus on mutable factors fistula repair-related characteristics and post-repair behaviors and exposures, accounting for immutable participant baseline sociodemographic and fistula characteristics.
Aim 2: Identify predictors and characteristics of post-repair incontinence. Specifically, the investigators seek to identify predictors of post-repair incontinence (see Aim 1) in our longitudinal cohort, focusing on: a) persistent incontinence following surgery at multiple time-points; and b) time to incident incontinence among women whose incontinence was initially resolved by surgery; using similar methods to Aim 1.
Aim 3: Identify feasible and acceptable strategies for modifying key risk factors of adverse outcome. To improve the translation of our research findings from Aims 1 and 2 into practice, the investigators will engage in an iterative process with key stakeholders to understand their perspectives on potential strategies for modifying important risk factors influencing post-repair fistula breakdown, recurrence, and incontinence. The investigators will purposively recruit a sub-sample of cohort participants (n=40) and other key stakeholders such as families, community members, and fistula care providers (n=40) for in-depth interview, followed by iterative participatory work with our qualitative sample to refine acceptability and feasibility concerns and ultimately to guide intervention strategy development.
- Conditions
- Female Genital Fistula, Incontinence
- Keywords
- Surgical repair breakdown, Obstetrics fistula, Fistula, Incontinence, Urine incontinence, Fistula repair, Fistula recurrence
- Medical subject headings
- Fistula, Nocturnal Enuresis
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to post-repair fistula breakdown
Proportion of women who experience fistula breakdown (a reopening of the fistula following repair, prior to the complete healing or de novo fistula occurrence as confirmed by a positive methylene blue dye test) and reported as the incidence by the total person-time observed and measured up to 36 months following index fistula repair
Measured: Through 36 months following study enrollment
Time to post-repair urinary incontinence
Proportion of women who experience post-repair incontinence (as measured through urinary incontinence with confirmed negative methylene blue dye test indicated complete fistula closure) measured up to 36 months following index fistula repair
Measured: Through 36 months following study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start20 May 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (92)Papers the sponsor has linked to this study.
- Other trials for Female Genital FistulaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Infectious Diseases Research Collaboration, Uganda, Makerere University
- Responsible party
- Sponsor
- Investigators
- Alison El Ayadi, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437939
- Sponsor's protocol ID
- A137001
- Other IDs
- R01HD101570
- Acronym
- Mulisa
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2022
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Bernis L. Obstetric fistula: guiding principles for clinical management and programme development, a new WHO guideline. Int J Gynaecol Obstet. 2007 Nov;99 Suppl 1:S117-21. doi: 10.1016/j.ijgo.2007.06.032. Epub 2007 Sep 18.
PubMed 17880979Wall LL, Arrowsmith SD, Briggs ND, Browning A, Lassey A. The obstetric vesicovaginal fistula in the developing world. Obstet Gynecol Surv. 2005 Jul;60(7 Suppl 1):S3-S51. doi: 10.1097/00006254-200507001-00002. No abstract available.
PubMed 16034313Hilton P. Vesico-vaginal fistulas in developing countries. Int J Gynaecol Obstet. 2003 Sep;82(3):285-95. doi: 10.1016/s0020-7292(03)00222-4.
PubMed 14499975Hilton P, Ward A. Epidemiological and surgical aspects of urogenital fistulae: a review of 25 years' experience in southeast Nigeria. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9(4):189-94. doi: 10.1007/BF01901602.
PubMed 9795822Arrowsmith S, Hamlin EC, Wall LL. Obstructed labor injury complex: obstetric fistula formation and the multifaceted morbidity of maternal birth trauma in the developing world. Obstet Gynecol Surv. 1996 Sep;51(9):568-74. doi: 10.1097/00006254-199609000-00024.
PubMed 8873157Wall LL, Arrowsmith SD, Briggs ND, Lassey A. Urinary Incontinence in the Developing World: The Obstetric Fistula. In: Abrams P, Cardozo L, Khoury S, Wein A, eds. Incontinence. Plymouth, U.K.: Health Publication Ltd; 2002.
Zeleke BM, Ayele TA, Woldetsadik MA, Bisetegn TA, Adane AA. Depression among women with obstetric fistula, and pelvic organ prolapse in northwest Ethiopia. BMC Psychiatry. 2013 Sep 26;13:236. doi: 10.1186/1471-244X-13-236.
PubMed 24070342Browning A, Fentahun W, Goh JT. The impact of surgical treatment on the mental health of women with obstetric fistula. BJOG. 2007 Nov;114(11):1439-41. doi: 10.1111/j.1471-0528.2007.01419.x. Epub 2007 Sep 27.
PubMed 17903234Goh JT, Sloane KM, Krause HG, Browning A, Akhter S. Mental health screening in women with genital tract fistulae. BJOG. 2005 Sep;112(9):1328-30. doi: 10.1111/j.1471-0528.2005.00712.x.
PubMed 16101616Browning 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 16489933Nielsen HS, Lindberg L, Nygaard U, Aytenfisu H, Johnston OL, Sorensen B, Rudnicki M, Crangle M, Lawson R, Duffy S. A community-based long-term follow up of women undergoing obstetric fistula repair in rural Ethiopia. BJOG. 2009 Aug;116(9):1258-64. doi: 10.1111/j.1471-0528.2009.02200.x. Epub 2009 May 14.
PubMed 19459865Delamou A, Utz B, Delvaux T, Beavogui AH, Shahabuddin A, Koivogui A, Leveque A, Zhang WH, De Brouwere V. Pregnancy and childbirth after repair of obstetric fistula in sub-Saharan Africa: Scoping Review. Trop Med Int Health. 2016 Nov;21(11):1348-1365. doi: 10.1111/tmi.12771. Epub 2016 Sep 6.
PubMed 27596732Delamou A, Delvaux T, El Ayadi AM, Tripathi V, Camara BS, Beavogui AH, Romanzi L, Cole B, Bouedouno P, Diallo M, Barry TH, Camara M, Diallo K, Leveque A, Zhang WH, De Brouwere V. Fistula recurrence, pregnancy, and childbirth following successful closure of female genital fistula in Guinea: a longitudinal study. Lancet Glob Health. 2017 Nov;5(11):e1152-e1160. doi: 10.1016/S2214-109X(17)30366-2. Epub 2017 Sep 21.
PubMed 28941996Frajzyngier V, Ruminjo J, Barone MA. Factors influencing urinary fistula repair outcomes in developing countries: a systematic review. Am J Obstet Gynecol. 2012 Oct;207(4):248-58. doi: 10.1016/j.ajog.2012.02.006. Epub 2012 Feb 20.
PubMed 22475385El Ayadi AM, Barageine J, Korn A, Kakaire O, Turan J, Obore S, Byamugisha J, Lester F, Nalubwama H, Mwanje H, Tripathi V, Miller S. Trajectories of women's physical and psychosocial health following obstetric fistula repair in Uganda: a longitudinal study. Trop Med Int Health. 2019 Jan;24(1):53-64. doi: 10.1111/tmi.13178. Epub 2018 Nov 18.
PubMed 30372572
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital
- ClinicalTrials.gov ID
- NCT05437939
- Acronym / sponsor ID
- Mulisa / A137001
- Conditions
- Female Genital Fistula, Incontinence
- Keywords
- Surgical repair breakdown, Obstetrics fistula, Fistula, Incontinence, Urine incontinence, Fistula repair, Fistula recurrence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 802 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Infectious Diseases Research Collaboration, Uganda, Makerere University
- Study start
- 20 May 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 29 Jun 2022 (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.
Following genital fistula repair, fistula repair breakdown and recurrence, persistent and incidence incontinence are major adverse outcomes, limiting women's health and wellbeing. Using a prospective design, the investigators seek to identify modifiable risk factors to establish key targets for intervention, followed by qualitative work to refine the feasibility and acceptability of potential intervention strategies.
Detailed description
Although improved global surgical access has begun to reduce the significant physical, psychosocial, and economic consequences of fistula, women with successful surgery face adverse post-repair risks. Emerging research has identified post-repair fistula recurrence in up to 14% of women following surgery, with many recurrences occurring within the first 12 months. Post-repair incontinence continues in up to 33% of women despite closed fistula, with some women developing incident incontinence after previously successful resolution through fistula surgery. However, the limited evidence base on factors contributing to adverse outcomes limits interventions to improve women's health and quality of life following genital fistula repair.
The investigators hypothesize that important independent predictors of vesicovaginal fistula repair breakdown and recurrence will include indications of fistula severity, strenuous labor, early resumption of sexual intercourse and subsequent pregnancy. Further modifiable characteristics whose potential contribution the investigators seek to establish for these adverse outcomes include other post-repair behaviors and exposures. To test these hypotheses and explore additional contributors to adverse outcomes, the investigators will leverage the research infrastructure the investigators have developed at several fistula repair sites in Uganda to lead a 3-year longitudinal cohort study of up to 1000 women following genital fistula repair. The investigators will collect data on sociodemographic characteristics, fistula and repair-related characteristics at fistula repair, and data on post-repair behaviors and exposures quarterly. If participants report key symptoms (recurrence and incontinence), the investigators will confirm these outcomes by clinical validation through physical examination. The investigators will calculate incidence and establish temporal relationships of a range of exposures with adverse outcomes to identify key targets for intervention. The investigators will then engage key stakeholders in iterative qualitative work framed by key behavioral and implementation science theories to enhance translation of our quantitative findings into intervention strategies that are feasible and acceptable in this context. This mixed-methods work has a strong potential to directly influence programming to reduce adverse outcomes following genital fistula repair.
Aim 1: Identify predictors of post-repair fistula breakdown and recurrence. The investigators will use survival analysis methods to compare baseline and time-varying patient characteristics of women in our longitudinal cohort who develop post-repair fistula breakdown and recurrence compared to those who do not. Assessment will focus on mutable factors fistula repair-related characteristics and post-repair behaviors and exposures, accounting for immutable participant baseline sociodemographic and fistula characteristics.
Aim 2: Identify predictors and characteristics of post-repair incontinence. Specifically, the investigators seek to identify predictors of post-repair incontinence (see Aim 1) in our longitudinal cohort, focusing on: a) persistent incontinence following surgery at multiple time-points; and b) time to incident incontinence among women whose incontinence was initially resolved by surgery; using similar methods to Aim 1.
Aim 3: Identify feasible and acceptable strategies for modifying key risk factors of adverse outcome. To improve the translation of our research findings from Aims 1 and 2 into practice, the investigators will engage in an iterative process with key stakeholders to understand their perspectives on potential strategies for modifying important risk factors influencing post-repair fistula breakdown, recurrence, and incontinence. The investigators will purposively recruit a sub-sample of cohort participants (n=40) and other key stakeholders such as families, community members, and fistula care providers (n=40) for in-depth interview, followed by iterative participatory work with our qualitative sample to refine acceptability and feasibility concerns and ultimately to guide intervention strategy development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to n=1000 women with successful (closed) vesicovaginal fistula repair who are 18 and older or 15-17 year old emancipated minors (per Ugandan law) will be eligible to participate from fistula surgery centers and hospitals participating in the study as recruitment sites.
Key inclusion criteria (4 listed)
- Vesicovaginal fistula
- Completed surgery with confirmed surgical closure
- Age 15 or above, with ages 15-17 meeting criteria for emancipated minor
- Capable of providing informed consent
Key exclusion criteria (1 listed)
- None beyond above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to post-repair fistula breakdown
Time frame: Through 36 months following study enrollment
Proportion of women who experience fistula breakdown (a reopening of the fistula following repair, prior to the complete healing or de novo fistula occurrence as confirmed by a positive methylene blue dye test) and reported as the incidence by the total person-time observed and measured up to 36 months following index fistula repair
Time to post-repair urinary incontinence
Time frame: Through 36 months following study enrollment
Proportion of women who experience post-repair incontinence (as measured through urinary incontinence with confirmed negative methylene blue dye test indicated complete fistula closure) measured up to 36 months following index fistula repair
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 17880979de Bernis L. Obstetric fistula: guiding principles for clinical management and programme development, a new WHO guideline. Int J Gynaecol Obstet. 2007 Nov;99 Suppl 1:S117-21. doi: 10.1016/j.ijgo.2007.06.032. Epub 2007 Sep 18.
- Background: PubMed 16034313Wall LL, Arrowsmith SD, Briggs ND, Browning A, Lassey A. The obstetric vesicovaginal fistula in the developing world. Obstet Gynecol Surv. 2005 Jul;60(7 Suppl 1):S3-S51. doi: 10.1097/00006254-200507001-00002. No abstract available.
- Background: PubMed 14499975Hilton P. Vesico-vaginal fistulas in developing countries. Int J Gynaecol Obstet. 2003 Sep;82(3):285-95. doi: 10.1016/s0020-7292(03)00222-4.
- Background: PubMed 9795822Hilton P, Ward A. Epidemiological and surgical aspects of urogenital fistulae: a review of 25 years' experience in southeast Nigeria. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9(4):189-94. doi: 10.1007/BF01901602.
- Background: PubMed 8873157Arrowsmith S, Hamlin EC, Wall LL. Obstructed labor injury complex: obstetric fistula formation and the multifaceted morbidity of maternal birth trauma in the developing world. Obstet Gynecol Surv. 1996 Sep;51(9):568-74. doi: 10.1097/00006254-199609000-00024.
- BackgroundWall LL, Arrowsmith SD, Briggs ND, Lassey A. Urinary Incontinence in the Developing World: The Obstetric Fistula. In: Abrams P, Cardozo L, Khoury S, Wein A, eds. Incontinence. Plymouth, U.K.: Health Publication Ltd; 2002.
- Background: PubMed 24070342Zeleke BM, Ayele TA, Woldetsadik MA, Bisetegn TA, Adane AA. Depression among women with obstetric fistula, and pelvic organ prolapse in northwest Ethiopia. BMC Psychiatry. 2013 Sep 26;13:236. doi: 10.1186/1471-244X-13-236.
- Background: PubMed 17903234Browning A, Fentahun W, Goh JT. The impact of surgical treatment on the mental health of women with obstetric fistula. BJOG. 2007 Nov;114(11):1439-41. doi: 10.1111/j.1471-0528.2007.01419.x. Epub 2007 Sep 27.
- Background: PubMed 16101616Goh JT, Sloane KM, Krause HG, Browning A, Akhter S. Mental health screening in women with genital tract fistulae. BJOG. 2005 Sep;112(9):1328-30. doi: 10.1111/j.1471-0528.2005.00712.x.
- Background: 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.
- Background: PubMed 19459865Nielsen HS, Lindberg L, Nygaard U, Aytenfisu H, Johnston OL, Sorensen B, Rudnicki M, Crangle M, Lawson R, Duffy S. A community-based long-term follow up of women undergoing obstetric fistula repair in rural Ethiopia. BJOG. 2009 Aug;116(9):1258-64. doi: 10.1111/j.1471-0528.2009.02200.x. Epub 2009 May 14.
- Background: PubMed 27596732Delamou A, Utz B, Delvaux T, Beavogui AH, Shahabuddin A, Koivogui A, Leveque A, Zhang WH, De Brouwere V. Pregnancy and childbirth after repair of obstetric fistula in sub-Saharan Africa: Scoping Review. Trop Med Int Health. 2016 Nov;21(11):1348-1365. doi: 10.1111/tmi.12771. Epub 2016 Sep 6.
- 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.
Alison El Ayadi, ScD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Genital Fistula and Incontinence, run by University of California, San Francisco at 1 site in Uganda.
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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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 Uganda. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to post-repair fistula breakdown (time frame: Through 36 months following study enrollment). The study lists 2 primary outcomes in all. 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 NCT05437939, which also lists 92 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 14 Jul 2026.