Obstetric FistulaCOPENCT05444504
Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
A study testing Cup and Cup+ in people with Obstetric Fistula and Fistula, run by University of California, San Francisco at 3 sites in 2 countries.
Trial summary
The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Obstetric Fistula, Fistula, Fistula, Urinary
- What is being tested?
- Cup and Cup+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician)
- Willing to insert and remove cup/cup+
- Clear understanding of the study procedures
- Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery
- If previous fistula repair, ≥3mo post-delivery
- If recent birth, age 18+ or emancipated minor
- Speak English or local language
Who cannot join
- Any rectovaginal fistula
- Urinary leakage <6ml over 6 hours
- Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Ghana2 sites, 2 recruiting
- Recruiting
Mercy Women's Catholic Hospital
Mankessim
Dr. Gabriel Ganyaglo, MBChB, +233 244 807426, gganyaglo@hotmail.com
Gabriel Ganyaglo, MBChB
- Recruiting
Tamale Fistula Center
Tamale
Gabriel Ganyaglo, MBChB, +233 244 807426, gganyaglo@hotmail.com
Gabriel Ganyaglo, MBChB
Kenya1 site, 1 recruiting
- Enrolling by invitation
Gynocare Women's and fistula hospital
Eldoret
About this study
Official title: Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial
The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.
Read the detailed description
Obstetric fistula is a traumatic maternal morbidity resulting in severe urinary incontinence that increases stigma and reduces quality of life. The estimated two million women with fistula, most in sub-Saharan Africa, face substantial multi-level barriers to surgical repair. Women need an acceptable non-surgical option for therapeutic management of fistula-related urinary incontinence, yet no non-surgical standard of care exists. Use of an insertable silicone vaginal cup has great potential for fistula management; it is effective for menstrual management and efficacious at reducing short-term fistula urinary leakage.
The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity. Using a cross-over design for efficiency, 100 participants will be randomized to one of two sequences of leaking freely, cup, and cup+ at fistula centers in Ghana, Kenya, and Uganda and observed for four days (total observations=400). Each treatment (cup, cup+ or leaking freely) is used for 24h for day and night use, then crossover. Data are captured through self-report and clinical checklist. On day 4, participants are re-randomized to use cup or cup+ at home for 3 months. Acceptability assessment is informed by implementation and health behavior theory.
Aim 1. To quantify the effectiveness and comparative effectiveness of the cup and cup+. The trial will compare objective and patient-reported measures of effectiveness of the cup and cup+ to leaking freely and of the cup to the cup+. Short-term assessment will be objective (urinary leakage; 8, 24hrs), long-term assessment will be patient-reported (QoL; 1-3 months).
Aim 2. To examine acceptability of cup and cup+. User and implementer acceptability will be assessed using a sequential explanatory mixed-methods design. Acceptability among trial participants will be measured longitudinally (1-3 months). User and implementer acceptability will be examined within in-depth interviews of selected trial participants (n~30) at 3 months and potential implementers (ob/gyns, midwives/nurses, community health workers, n~20).
Aim 3. To explore the material and opportunity costs to non-surgical fistula management. Surveys and time motion study among trial participants at facility and community will estimate direct and indirect costs of fistula management from a patient perspective. The long-term goal of the proposed work is to overcome barriers to comprehensive fistula care and increase quality of life through an acceptable, non-surgical option for therapeutic management of fistula.
- Conditions
- Obstetric Fistula, Fistula, Fistula, Urinary, Fistula, Vaginal
- Being tested
- Cup, Cup+
- Keywords
- Menstrual cup, Urinary incontinence, Fistula, Obstetric Fistula, Fistula, Vaginal, Fistula, Urinary, Women's health, Quality of LIfe
- Medical subject headings
- Fistula, Urinary Fistula, Vaginal Fistula, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CupDevice
an insertable vaginal cup ('cup')
Cup+Device
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | 24 hours of use each of leaking freely, leaking freely, cup, and then cup+ Receives: Device: Cup; Device: Cup+ |
| Group 2 | Other | 24 hours of use each of leaking freely, cup, cup+, and then cup Receives: Device: Cup; Device: Cup+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in volume of observed urine leakage
Urine leakage will be measured in mL using pad weight
Measured: baseline to 6 hours
Secondary outcomes (10)
Mean change in volume of perceived urine leakage
Perceived urine leakage will be measured by the International Consultation on Incontinence Questionnaire SF (ICIQ-SF). This score ranges from 0-21 with higher scores indicating greater incontinence.
Measured: baseline vs. 6 hours, 24 hours,1 month, 2 months and 3 months
Mean change in WHO Quality of Life BREF (WHOQOL-BREF) score
Quality of life will be measured using the WHOQOL-BREF. The score ranges from 0-100 with higher scores indicating higher quality of life.
Measured: baseline vs. 24 hours, 1 month, 2 months and 3 months
Mean change in fistula-related stigma scale
Stigma will be measured using the fistula-related stigma scale, and enacted and internalized subscales. This score ranges from 0-100 with higher scores indicating higher stigma.
Measured: baseline vs. 1 month, 2 months and 3 months
Mean change in fistula management costs over time
Fistula management costs will be calculated by combining the total material costs and lost wages in Ghanaian Cedi (local currency) over time. Time in minutes will inform calculations of lost wages using prevailing wage rates for the study population. The mean change in cost will be from baseline to 3 months.
Measured: baseline vs. 1 month, 2 months, and 3 months
Mean change in sleep satisfaction using the WHO sleep index
Sleep satisfaction using the adapted WHO sleep index. The score ranges from 1-5 where 1 is least satisfied and 5 is very satisfied.
Measured: baseline vs. 1 month, 2 months, and 3 months
Mean change in Coping Orientation to Problems Experienced Inventory (BRIEF) Coping scale
Coping will be measured using the modified BRIEF Coping scale. The score ranges from 0-100 with higher scores indicating better coping.
Measured: baseline vs. 1 month, 2 months, and 3 months
Mean change in perceived empowerment over time
Empowerment change in the proportion of users across physical mobility, participation in income-generating activities, bodily autonomy, household decision making, reproductive autonomy, and social participation. Individual measures will be captured using a scale of 1-5, with 1 indicating lower empowerment and 5 higher.
Measured: baseline vs. 1 month, 2 months, and 3 months
Changes in perceived safety over time
change in the proportion of users who report any adverse events with use of the intervention model at 1, 2, and 3-month follow up
Measured: baseline vs. 6 hours, 24 hours, 1 month, 2 months, and 3 months
Changes in user acceptability of the intervention over time
Proportion of users who report the intervention as acceptable measured across domains including easy to insert, remove, clean, comfortable to wear, interference with activities, perceived efficacy, self-efficacy, intent to use, and reported using a mean acceptability scale (based on composite score of acceptability items) regarding the intervention model. Standardized range will be 0-100, with higher values meaning greater acceptability and lower values lower acceptability.
Measured: 6 hours vs. 24 hours, 1 month, 2 months, and 3 months
Changes in post-fistula repair reintegration scale
Reintegration will be measured using the post-fistula repair reintegration scale and subdomains comfort with relatives, relationship, general life satisfaction, family needs, and social engagement. The score ranges from 0-100 with higher scores indicating higher reintegration/functional status.
Measured: baseline vs. 1 month, 2 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start15 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Obstetric 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will compare two intervention models among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity (Table 1). Using a crossover design for efficiency, the investigators will randomize 100 participants to one of two sequences of leaking freely, cup, and cup+ at fistula centers in Ghana, Kenya, and Uganda, then re-randomize to continue using the cup or cup+ at home for up to 3 months. This design includes repeated measures of leakage (4 per participant, total obs=400), uses participants as their own controls, reduces the risk of confounding due to intervention order, and captures usual leaking variability through multiple measures.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Korle-Bu Teaching Hospital, Accra, Ghana, Restore Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gynocare Women's and Fistula Hospital, Eldorat, Kenya
- Responsible party
- Sponsor
- Investigators
- Alison El Ayadi, ScD, Principal investigator, University of California, San FranciscoNessa Ryan, PhD, Study director, Restore Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444504
- Sponsor's protocol ID
- P0555006
- Other IDs
- R01HD108236
- Acronym
- COPE
- 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
- Yes: Quantitative data will be deidentified and made available after all study publications have been completed without cost to researchers and analysts. Qualitative data and associated documentation will be available to users under a data-sharing agreement.
Publications
Wall LL. Obstetric vesicovaginal fistula as an international public-health problem. Lancet. 2006 Sep 30;368(9542):1201-9. doi: 10.1016/S0140-6736(06)69476-2.
PubMed 17011947De Ridder D. Vesicovaginal fistula: a major healthcare problem. Curr Opin Urol. 2009 Jul;19(4):358-61. doi: 10.1097/MOU.0b013e32832ae1b7.
PubMed 19440154Adler AJ, Ronsmans C, Calvert C, Filippi V. Estimating the prevalence of obstetric fistula: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2013 Dec 30;13:246. doi: 10.1186/1471-2393-13-246.
PubMed 24373152Tebeu PM, Fomulu JN, Khaddaj S, de Bernis L, Delvaux T, Rochat CH. Risk factors for obstetric fistula: a clinical review. Int Urogynecol J. 2012 Apr;23(4):387-94. doi: 10.1007/s00192-011-1622-x. Epub 2011 Dec 6.
PubMed 22143450GHS. Report on Fistula Burden in Ghana. 2015.
Barageine JK, Beyeza-Kashesya J, Byamugisha JK, Tumwesigye NM, Almroth L, Faxelid E. "I am alone and isolated": a qualitative study of experiences of women living with genital fistula in Uganda. BMC Womens Health. 2015 Sep 10;15:73. doi: 10.1186/s12905-015-0232-z.
PubMed 26359255Mwini-Nyaledzigbor PP, Agana AA, Pilkington FB. Lived experiences of Ghanaian women with obstetric fistula. Health Care Women Int. 2013;34(6):440-60. doi: 10.1080/07399332.2012.755981.
PubMed 23641897Tellier S, Hyttel M. Menstrual Health Management in East and Southern Africa: a Review Paper. United Nations Population Fund and WoMena; 2018.
Baker Z, Bellows B, Bach R, Warren C. Barriers to obstetric fistula treatment in low-income countries: a systematic review. Trop Med Int Health. 2017 Aug;22(8):938-959. doi: 10.1111/tmi.12893. Epub 2017 Jul 20.
PubMed 28510988Banke-Thomas AO, Wilton-Waddell OE, Kouraogo SF, Mueller E. Current evidence supporting obstetric fistula prevention strategies in sub Saharan Africa: a systematic review of the literature. Afr J Reprod Health. 2014 Sep;18(3):118-27.
PubMed 25438516Fernandez-Romero JA, Deal C, Herold BC, Schiller J, Patton D, Zydowsky T, Romano J, Petro CD, Narasimhan M. Multipurpose prevention technologies: the future of HIV and STI protection. Trends Microbiol. 2015 Jul;23(7):429-436. doi: 10.1016/j.tim.2015.02.006. Epub 2015 Mar 7.
PubMed 25759332North BB, Oldham MJ. Preclinical, clinical, and over-the-counter postmarketing experience with a new vaginal cup: menstrual collection. J Womens Health (Larchmt). 2011 Feb;20(2):303-11. doi: 10.1089/jwh.2009.1929. Epub 2011 Jan 1.
PubMed 21194348Beksinska ME, Smit J, Greener R, Todd CS, Lee ML, Maphumulo V, Hoffmann V. Acceptability and performance of the menstrual cup in South Africa: a randomized crossover trial comparing the menstrual cup to tampons or sanitary pads. J Womens Health (Larchmt). 2015 Feb;24(2):151-8. doi: 10.1089/jwh.2014.5021.
PubMed 25682816Hyttel M, Thomsen CF, Luff B, Tellier M, Storrusten H, Nyakato VN. Drivers and challenges to use of menstrual cups among schoolgirls in rural Uganda: A qualitative study. Waterlines. 2017;36(2):109-24.
Russell KW, Robinson RE, Mone MC, Scaife CL. Enterovaginal or Vesicovaginal Fistula Control Using a Silicone Cup. Obstet Gynecol. 2016 Dec;128(6):1365-1368. doi: 10.1097/AOG.0000000000001745.
PubMed 27824744
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
- Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05444504
- Acronym / sponsor ID
- COPE / P0555006
- Conditions
- Obstetric Fistula, Fistula, Fistula, Urinary, Fistula, Vaginal
- Keywords
- Menstrual cup, Urinary incontinence, Fistula, Obstetric Fistula, Fistula, Vaginal, Fistula, Urinary, Women's health, Quality of LIfe
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Korle-Bu Teaching Hospital, Accra, Ghana, Restore Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gynocare Women's and Fistula Hospital, Eldorat, Kenya
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jul 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.
The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.
Detailed description
Obstetric fistula is a traumatic maternal morbidity resulting in severe urinary incontinence that increases stigma and reduces quality of life. The estimated two million women with fistula, most in sub-Saharan Africa, face substantial multi-level barriers to surgical repair. Women need an acceptable non-surgical option for therapeutic management of fistula-related urinary incontinence, yet no non-surgical standard of care exists. Use of an insertable silicone vaginal cup has great potential for fistula management; it is effective for menstrual management and efficacious at reducing short-term fistula urinary leakage.
The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity. Using a cross-over design for efficiency, 100 participants will be randomized to one of two sequences of leaking freely, cup, and cup+ at fistula centers in Ghana, Kenya, and Uganda and observed for four days (total observations=400). Each treatment (cup, cup+ or leaking freely) is used for 24h for day and night use, then crossover. Data are captured through self-report and clinical checklist. On day 4, participants are re-randomized to use cup or cup+ at home for 3 months. Acceptability assessment is informed by implementation and health behavior theory.
Aim 1. To quantify the effectiveness and comparative effectiveness of the cup and cup+. The trial will compare objective and patient-reported measures of effectiveness of the cup and cup+ to leaking freely and of the cup to the cup+. Short-term assessment will be objective (urinary leakage; 8, 24hrs), long-term assessment will be patient-reported (QoL; 1-3 months).
Aim 2. To examine acceptability of cup and cup+. User and implementer acceptability will be assessed using a sequential explanatory mixed-methods design. Acceptability among trial participants will be measured longitudinally (1-3 months). User and implementer acceptability will be examined within in-depth interviews of selected trial participants (n~30) at 3 months and potential implementers (ob/gyns, midwives/nurses, community health workers, n~20).
Aim 3. To explore the material and opportunity costs to non-surgical fistula management. Surveys and time motion study among trial participants at facility and community will estimate direct and indirect costs of fistula management from a patient perspective. The long-term goal of the proposed work is to overcome barriers to comprehensive fistula care and increase quality of life through an acceptable, non-surgical option for therapeutic management of fistula.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will compare two intervention models among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity (Table 1). Using a crossover design for efficiency, the investigators will randomize 100 participants to one of two sequences of leaking freely, cup, and cup+ at fistula centers in Ghana, Kenya, and Uganda, then re-randomize to continue using the cup or cup+ at home for up to 3 months. This design includes repeated measures of leakage (4 per participant, total obs=400), uses participants as their own controls, reduces the risk of confounding due to intervention order, and captures usual leaking variability through multiple measures.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Device: Cup, Device: Cup+24 hours of use each of leaking freely, leaking freely, cup, and then cup+ |
| Group 2 | Other | Device: Cup, Device: Cup+24 hours of use each of leaking freely, cup, cup+, and then cup |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician)
- Willing to insert and remove cup/cup+
- Clear understanding of the study procedures
- Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery
- If previous fistula repair, ≥3mo post-delivery
Key exclusion criteria (3 listed)
- Any rectovaginal fistula
- Urinary leakage <6ml over 6 hours
- Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.
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 |
|---|---|---|
| Cupan insertable vaginal cup ('cup') | Device | Group 1, Group 2 |
| Cup+the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity | Device | Group 1, Group 2 |
Primary outcome
Mean change in volume of observed urine leakage
Time frame: baseline to 6 hours
Urine leakage will be measured in mL using pad weight
10 secondary outcomes
Mean change in volume of perceived urine leakage
Time frame: baseline vs. 6 hours, 24 hours,1 month, 2 months and 3 months
Mean change in WHO Quality of Life BREF (WHOQOL-BREF) score
Time frame: baseline vs. 24 hours, 1 month, 2 months and 3 months
Mean change in fistula-related stigma scale
Time frame: baseline vs. 1 month, 2 months and 3 months
Mean change in fistula management costs over time
Time frame: baseline vs. 1 month, 2 months, and 3 months
Mean change in sleep satisfaction using the WHO sleep index
Time frame: baseline vs. 1 month, 2 months, and 3 months
Mean change in Coping Orientation to Problems Experienced Inventory (BRIEF) Coping scale
Time frame: baseline vs. 1 month, 2 months, and 3 months
Mean change in perceived empowerment over time
Time frame: baseline vs. 1 month, 2 months, and 3 months
Changes in perceived safety over time
Time frame: baseline vs. 6 hours, 24 hours, 1 month, 2 months, and 3 months
Changes in user acceptability of the intervention over time
Time frame: 6 hours vs. 24 hours, 1 month, 2 months, and 3 months
Changes in post-fistula repair reintegration scale
Time frame: baseline vs. 1 month, 2 months, and 3 months
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 17011947Wall LL. Obstetric vesicovaginal fistula as an international public-health problem. Lancet. 2006 Sep 30;368(9542):1201-9. doi: 10.1016/S0140-6736(06)69476-2.
- Background: PubMed 19440154De Ridder D. Vesicovaginal fistula: a major healthcare problem. Curr Opin Urol. 2009 Jul;19(4):358-61. doi: 10.1097/MOU.0b013e32832ae1b7.
- Background: PubMed 24373152Adler AJ, Ronsmans C, Calvert C, Filippi V. Estimating the prevalence of obstetric fistula: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2013 Dec 30;13:246. doi: 10.1186/1471-2393-13-246.
- Background: PubMed 22143450Tebeu PM, Fomulu JN, Khaddaj S, de Bernis L, Delvaux T, Rochat CH. Risk factors for obstetric fistula: a clinical review. Int Urogynecol J. 2012 Apr;23(4):387-94. doi: 10.1007/s00192-011-1622-x. Epub 2011 Dec 6.
- BackgroundGHS. Report on Fistula Burden in Ghana. 2015.
- Background: PubMed 26359255Barageine JK, Beyeza-Kashesya J, Byamugisha JK, Tumwesigye NM, Almroth L, Faxelid E. "I am alone and isolated": a qualitative study of experiences of women living with genital fistula in Uganda. BMC Womens Health. 2015 Sep 10;15:73. doi: 10.1186/s12905-015-0232-z.
- Background: PubMed 23641897Mwini-Nyaledzigbor PP, Agana AA, Pilkington FB. Lived experiences of Ghanaian women with obstetric fistula. Health Care Women Int. 2013;34(6):440-60. doi: 10.1080/07399332.2012.755981.
- BackgroundTellier S, Hyttel M. Menstrual Health Management in East and Southern Africa: a Review Paper. United Nations Population Fund and WoMena; 2018.
- Background: PubMed 28510988Baker Z, Bellows B, Bach R, Warren C. Barriers to obstetric fistula treatment in low-income countries: a systematic review. Trop Med Int Health. 2017 Aug;22(8):938-959. doi: 10.1111/tmi.12893. Epub 2017 Jul 20.
- Background: PubMed 25438516Banke-Thomas AO, Wilton-Waddell OE, Kouraogo SF, Mueller E. Current evidence supporting obstetric fistula prevention strategies in sub Saharan Africa: a systematic review of the literature. Afr J Reprod Health. 2014 Sep;18(3):118-27.
- Background: PubMed 25759332Fernandez-Romero JA, Deal C, Herold BC, Schiller J, Patton D, Zydowsky T, Romano J, Petro CD, Narasimhan M. Multipurpose prevention technologies: the future of HIV and STI protection. Trends Microbiol. 2015 Jul;23(7):429-436. doi: 10.1016/j.tim.2015.02.006. Epub 2015 Mar 7.
- Background: PubMed 21194348North BB, Oldham MJ. Preclinical, clinical, and over-the-counter postmarketing experience with a new vaginal cup: menstrual collection. J Womens Health (Larchmt). 2011 Feb;20(2):303-11. doi: 10.1089/jwh.2009.1929. Epub 2011 Jan 1.
- Individual participant dataSharing planned: Yes. Quantitative data will be deidentified and made available after all study publications have been completed without cost to researchers and analysts. Qualitative data and associated documentation will be available to users under a data-sharing agreement.
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.
Alison El Ayadi, ScD principal investigator
University of California, San Francisco
Nessa Ryan, PhD study director
Restore Health
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cup and Cup+ in people with Obstetric Fistula and Fistula, run by University of California, San Francisco at 3 sites in 2 countries.
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 7 inclusion and 3 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: looking for participants now, 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 3 sites in Ghana, Kenya. 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?
Contact Nessa E Ryan, PhD (17048062062, ryann01@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in volume of observed urine leakage (time frame: baseline to 6 hours). 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 NCT05444504, which also lists 52 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.