Adverse Outcomes Following Female Genital Fistula Repair

NCT05437939 | Active Not Recruiting DMC

• 2 other identifiers: A137001R01HD101570
• Study Type: observational
• Target: 802
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Female Genital Fistula; Incontinence

Keywords

Surgical repair breakdown; Obstetrics fistula; Fistula; Incontinence; Urine incontinence; Fistula repair; Fistula recurrence

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Through 36 months following study enrollment

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• None beyond above

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Makerere University: collaborator

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Related Publications (91)

• 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.

  PMID: 17880979 BACKGROUND

• Wall 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.

  PMID: 16034313 BACKGROUND

• Hilton 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.

  PMID: 14499975 BACKGROUND

• Hilton 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.

  PMID: 9795822 BACKGROUND

• Arrowsmith 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.

  PMID: 8873157 BACKGROUND

• Wall 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

• 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.

  PMID: 24070342 BACKGROUND

• Browning 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.

  PMID: 17903234 BACKGROUND

• Goh 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.

  PMID: 16101616 BACKGROUND

• 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.

  PMID: 16489933 BACKGROUND

• Nielsen 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.

  PMID: 19459865 BACKGROUND

• Delamou 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.

  PMID: 27596732 BACKGROUND

• Delamou 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.

  PMID: 28941996 BACKGROUND

• Frajzyngier 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.

  PMID: 22475385 BACKGROUND

• El 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.

  PMID: 30372572 BACKGROUND

• Bengtson AM, Kopp D, Tang JH, Chipungu E, Moyo M, Wilkinson J. Identifying Patients With Vesicovaginal Fistula at High Risk of Urinary Incontinence After Surgery. Obstet Gynecol. 2016 Nov;128(5):945-953. doi: 10.1097/AOG.0000000000001687.

  PMID: 27741181 BACKGROUND

• Evoh NJ, Akinla O. Reproductive performance after the repair of obstetric vesico-vaginal fistulae. Ann Clin Res. 1978 Dec;10(6):303-6.

  PMID: 742828 BACKGROUND

• Browning A, Menber B. Women with obstetric fistula in Ethiopia: a 6-month follow up after surgical treatment. BJOG. 2008 Nov;115(12):1564-9. doi: 10.1111/j.1471-0528.2008.01900.x.

  PMID: 19035992 BACKGROUND

• Kayondo M, Wasswa S, Kabakyenga J, Mukiibi N, Senkungu J, Stenson A, Mukasa P. Predictors and outcome of surgical repair of obstetric fistula at a regional referral hospital, Mbarara, western Uganda. BMC Urol. 2011 Dec 7;11:23. doi: 10.1186/1471-2490-11-23.

  PMID: 22151960 BACKGROUND

• Muleta M. Socio-demographic profile and obstetric experience of fistula patients managed at the Addis Ababa Fistula Hospital. Ethiop Med J. 2004 Jan;42(1):9-16.

  PMID: 15884272 BACKGROUND

• 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.

  PMID: 17011947 BACKGROUND

• Khisa AM, Nyamongo IK. Still living with fistula: an exploratory study of the experience of women with obstetric fistula following corrective surgery in West Pokot, Kenya. Reprod Health Matters. 2012 Dec;20(40):59-66. doi: 10.1016/S0968-8080(12)40661-9.

  PMID: 23245409 BACKGROUND

• El Ayadi AM, Barageine JK, Miller S, Byamugisha J, Nalubwama H, Obore S, Korn A, Sukumar S, Kakaire O, Mwanje H, Lester F, Turan JM. Women's experiences of fistula-related stigma in Uganda: a conceptual framework to inform stigma-reduction interventions. Cult Health Sex. 2020 Mar;22(3):352-367. doi: 10.1080/13691058.2019.1600721. Epub 2019 Apr 30.

  PMID: 31035913 BACKGROUND

• 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.

  PMID: 28510988 BACKGROUND

• 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.

  PMID: 26359255 BACKGROUND

• Mwini-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.

  PMID: 23641897 BACKGROUND

• Mselle LT, Moland KM, Evjen-Olsen B, Mvungi A, Kohi TW. "I am nothing": experiences of loss among women suffering from severe birth injuries in Tanzania. BMC Womens Health. 2011 Nov 15;11:49. doi: 10.1186/1472-6874-11-49.

  PMID: 22082132 BACKGROUND

• Wilson AL, Chipeta E, Kalilani-Phiri L, Taulo F, Tsui AO. Fertility and pregnancy outcomes among women with obstetric fistula in rural Malawi. Int J Gynaecol Obstet. 2011 Jun;113(3):196-8. doi: 10.1016/j.ijgo.2011.01.006. Epub 2011 Apr 1.

  PMID: 21457981 BACKGROUND

• Azhar RA, Bochner B, Catto J, Goh AC, Kelly J, Patel HD, Pruthi RS, Thalmann GN, Desai M. Enhanced Recovery after Urological Surgery: A Contemporary Systematic Review of Outcomes, Key Elements, and Research Needs. Eur Urol. 2016 Jul;70(1):176-187. doi: 10.1016/j.eururo.2016.02.051. Epub 2016 Mar 9.

  PMID: 26970912 BACKGROUND

• Korol E, Johnston K, Waser N, Sifakis F, Jafri HS, Lo M, Kyaw MH. A systematic review of risk factors associated with surgical site infections among surgical patients. PLoS One. 2013 Dec 18;8(12):e83743. doi: 10.1371/journal.pone.0083743. eCollection 2013.

  PMID: 24367612 BACKGROUND

• 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.

  PMID: 12015520 BACKGROUND

• Murray C, Goh JT, Fynes M, Carey MP. Urinary and faecal incontinence following delayed primary repair of obstetric genital fistula. BJOG. 2002 Jul;109(7):828-32. doi: 10.1111/j.1471-0528.2002.00124.x.

  PMID: 12135221 BACKGROUND

• Goh JT, Krause H, Tessema AB, Abraha G. Urinary symptoms and urodynamics following obstetric genitourinary fistula repair. Int Urogynecol J. 2013 Jun;24(6):947-51. doi: 10.1007/s00192-012-1948-z. Epub 2012 Oct 25.

  PMID: 23096530 BACKGROUND

• Boaz A, Hanney S, Borst R, O'Shea A, Kok M. How to engage stakeholders in research: design principles to support improvement. Health Res Policy Syst. 2018 Jul 11;16(1):60. doi: 10.1186/s12961-018-0337-6.

  PMID: 29996848 BACKGROUND

• Jull JE, Davidson L, Dungan R, Nguyen T, Woodward KP, Graham ID. A review and synthesis of frameworks for engagement in health research to identify concepts of knowledge user engagement. BMC Med Res Methodol. 2019 Nov 21;19(1):211. doi: 10.1186/s12874-019-0838-1.

  PMID: 31752691 BACKGROUND

• Shelef DQ, Rand C, Streisand R, Horn IB, Yadav K, Stewart L, Foushee N, Waters D, Teach SJ. Using stakeholder engagement to develop a patient-centered pediatric asthma intervention. J Allergy Clin Immunol. 2016 Dec;138(6):1512-1517. doi: 10.1016/j.jaci.2016.10.001. Epub 2016 Oct 12.

  PMID: 27744029 BACKGROUND

• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

  PMID: 21513547 BACKGROUND

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 BACKGROUND

• Birken SA, Powell BJ, Presseau J, Kirk MA, Lorencatto F, Gould NJ, Shea CM, Weiner BJ, Francis JJ, Yu Y, Haines E, Damschroder LJ. Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review. Implement Sci. 2017 Jan 5;12(1):2. doi: 10.1186/s13012-016-0534-z.

  PMID: 28057049 BACKGROUND

• Bentley MR, Mitchell N, Sutton L, Backhouse SH. Sports nutritionists' perspectives on enablers and barriers to nutritional adherence in high performance sport: A qualitative analysis informed by the COM-B model and theoretical domains framework. J Sports Sci. 2019 Sep;37(18):2075-2085. doi: 10.1080/02640414.2019.1620989. Epub 2019 May 24.

  PMID: 31124393 BACKGROUND

• Chater AM, Williams J, Courtenay M. The prescribing needs of community practitioner nurse prescribers: A qualitative investigation using the theoretical domains framework and COM-B. J Adv Nurs. 2019 Nov;75(11):2952-2968. doi: 10.1111/jan.14170. Epub 2019 Sep 3.

  PMID: 31423627 BACKGROUND

• Courtenay M, Rowbotham S, Lim R, Peters S, Yates K, Chater A. Examining influences on antibiotic prescribing by nurse and pharmacist prescribers: a qualitative study using the Theoretical Domains Framework and COM-B. BMJ Open. 2019 Jun 19;9(6):e029177. doi: 10.1136/bmjopen-2019-029177.

  PMID: 31221892 BACKGROUND

• Thompson LM, Diaz-Artiga A, Weinstein JR, Handley MA. Designing a behavioral intervention using the COM-B model and the theoretical domains framework to promote gas stove use in rural Guatemala: a formative research study. BMC Public Health. 2018 Feb 14;18(1):253. doi: 10.1186/s12889-018-5138-x.

  PMID: 29444650 BACKGROUND

• Flannery C, McHugh S, Anaba AE, Clifford E, O'Riordan M, Kenny LC, McAuliffe FM, Kearney PM, Byrne M. Enablers and barriers to physical activity in overweight and obese pregnant women: an analysis informed by the theoretical domains framework and COM-B model. BMC Pregnancy Childbirth. 2018 May 21;18(1):178. doi: 10.1186/s12884-018-1816-z.

  PMID: 29783933 BACKGROUND

• Browning A, Patel TL. FIGO initiative for the prevention and treatment of vaginal fistula. Int J Gynaecol Obstet. 2004 Aug;86(2):317-22. doi: 10.1016/j.ijgo.2004.05.003. No abstract available.

  PMID: 15289120 BACKGROUND

• Uganda Bureau of Statistics, ICF. Uganda Demographic and Health Survey 2016. Kampala, Uganda: UBOS and ICF, 2018.

  BACKGROUND

• Uganda Ministry of Health. National Obstetric Fistula Strategy 2011/2012-2015/2016. Kampala: Uganda Ministry of Health; 2011.

  BACKGROUND

• Direct Relief. Global Fistula Map. 2013. http://www.globalfistulamap.org/ (accessed Nov 1 2015).

  BACKGROUND

• McCurdie FK, Moffatt J, Jones K. Vesicovaginal fistula in Uganda. J Obstet Gynaecol. 2018 Aug;38(6):822-827. doi: 10.1080/01443615.2017.1407301. Epub 2018 Mar 9.

  PMID: 29523027 BACKGROUND

• Direct Relief, Fistula Foundation. Global Fistula Hub. 2019. https://www.globalfistulahub.org/ (accessed December 1 2020).

  BACKGROUND

• El Ayadi A, Nalubwama H, Barageine J, Neilands TB, Obore S, Byamugisha J, Kakaire O, Mwanje H, Korn A, Lester F, Miller S. Development and preliminary validation of a post-fistula repair reintegration instrument among Ugandan women. Reprod Health. 2017 Sep 2;14(1):109. doi: 10.1186/s12978-017-0372-8.

  PMID: 28865473 BACKGROUND

• DataReportal 2021. Digital 2021 Uganda, 2021.

  BACKGROUND

• Uganda Communications Commission. Market Performance Report: 1Q21. Kampala, Uganda: Uganda Communications Commission, 2021.

  BACKGROUND

• Stamatakos M, Sargedi C, Stasinou T, Kontzoglou K. Vesicovaginal fistula: diagnosis and management. Indian J Surg. 2014 Apr;76(2):131-6. doi: 10.1007/s12262-012-0787-y. Epub 2012 Dec 14.

  PMID: 24891778 BACKGROUND

• FIGO, Partners. Global Competency-Based Fistula Surgery Trainining Manual; 2011.

  BACKGROUND

• Hancock B. First Steps In Vesico-Vaginal Fistula Repair. London: The Royal Society of Medicine Press Ltd; 2005.

  BACKGROUND

• Hancock B, Browning A. A text book of practical obstetric fistula surgery. London: Royal Society of Medicine Press Ltd; 2009.

  BACKGROUND

• Kees Waaldijk. Step by step surgery of vesico vaginal fistulae. Edinburgh (UK): Campion Press; 1998.

  BACKGROUND

• Waaldijk K. Obstetrics fistula surgery art and science. Edinburgh, UK: Campion Press; 2008.

  BACKGROUND

• Wall LL. Preventing obstetric fistulas in low-resource countries: insights from a Haddon matrix. Obstet Gynecol Surv. 2012 Feb;67(2):111-21. doi: 10.1097/OGX.0b013e3182438788.

  PMID: 22325301 BACKGROUND

• Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996 Jun;77(6):805-12. doi: 10.1046/j.1464-410x.1996.00186.x.

  PMID: 8705212 BACKGROUND

• Martin F, Russell S, Seeley J. The WHOQOL BREF questionnaire in Luganda: Validation with a sample including people living with HIV in Uganda. Working Paper 46. Norwich, United Kingdom: School of International Development, University of East Anglia, 2013.

  BACKGROUND

• Webster J, Nicholas C, Velacott C, Cridland N, Fawcett L. Validation of the WHOQOL-BREF among women following childbirth. Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):132-7. doi: 10.1111/j.1479-828X.2009.01131.x.

  PMID: 20522068 BACKGROUND

• Lundberg P, Rukundo G, Ashaba S, Thorson A, Allebeck P, Ostergren PO, Cantor-Graae E. Poor mental health and sexual risk behaviours in Uganda: a cross-sectional population-based study. BMC Public Health. 2011 Feb 21;11:125. doi: 10.1186/1471-2458-11-125.

  PMID: 21338500 BACKGROUND

• Lundberg P, Cantor-Graae E, Rukundo G, Ashaba S, Ostergren PO. Urbanicity of place of birth and symptoms of psychosis, depression and anxiety in Uganda. Br J Psychiatry. 2009 Aug;195(2):156-62. doi: 10.1192/bjp.bp.108.051953.

  PMID: 19648549 BACKGROUND

• Hatcher AM, Tsai AC, Kumbakumba E, Dworkin SL, Hunt PW, Martin JN, Clark G, Bangsberg DR, Weiser SD. Sexual relationship power and depression among HIV-infected women in Rural Uganda. PLoS One. 2012;7(12):e49821. doi: 10.1371/journal.pone.0049821. Epub 2012 Dec 26.

  PMID: 23300519 BACKGROUND

• Bolton P, Wilk CM, Ndogoni L. Assessment of depression prevalence in rural Uganda using symptom and function criteria. Soc Psychiatry Psychiatr Epidemiol. 2004 Jun;39(6):442-7. doi: 10.1007/s00127-004-0763-3.

  PMID: 15205728 BACKGROUND

• Martin F, Russell S, Seeley J. Toward an understanding of the impact of HIV medication on quality of life in Uganda. 2013 Division of Health Psychology Annual Conference. Brighton, UK; 2013.

  BACKGROUND

• Rosenberg M. Society and the adolescent self-image. Princeton, NJ: Princeton University Press; 1965.

  BACKGROUND

• Holzemer WL, Human S, Arudo J, Rosa ME, Hamilton MJ, Corless I, Robinson L, Nicholas PK, Wantland DJ, Moezzi S, Willard S, Kirksey K, Portillo C, Sefcik E, Rivero-Mendez M, Maryland M. Exploring HIV stigma and quality of life for persons living with HIV infection. J Assoc Nurses AIDS Care. 2009 May-Jun;20(3):161-8. doi: 10.1016/j.jana.2009.02.002.

  PMID: 19427593 BACKGROUND

• Holzemer WL, Uys L, Makoae L, Stewart A, Phetlhu R, Dlamini PS, Greeff M, Kohi TW, Chirwa M, Cuca Y, Naidoo J. A conceptual model of HIV/AIDS stigma from five African countries. J Adv Nurs. 2007 Jun;58(6):541-51. doi: 10.1111/j.1365-2648.2007.04244.x. Epub 2007 May 1.

  PMID: 17484748 BACKGROUND

• Nakigudde J, Musisi S, Ehnvall A, Airaksinen E, Agren H. Adaptation of the multidimensional scale of perceived social support in a Ugandan setting. Afr Health Sci. 2009 Aug 1;9 Suppl 1(Suppl 1):S35-41.

  PMID: 20589159 BACKGROUND

• Osman A, Lamis DA, Freedenthal S, Gutierrez PM, McNaughton-Cassill M. The multidimensional scale of perceived social support: analyses of internal reliability, measurement invariance, and correlates across gender. J Pers Assess. 2014;96(1):103-12. doi: 10.1080/00223891.2013.838170. Epub 2013 Oct 3.

  PMID: 24090236 BACKGROUND

• Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.

  PMID: 2280326 BACKGROUND

• Cox CM, Hindin MJ, Otupiri E, Larsen-Reindorf R. Understanding couples' relationship quality and contraceptive use in Kumasi, Ghana. Int Perspect Sex Reprod Health. 2013 Dec;39(4):185-94. doi: 10.1363/3918513.

  PMID: 24393724 BACKGROUND

• Flynn KE, Lin L, Cyranowski JM, Reeve BB, Reese JB, Jeffery DD, Smith AW, Porter LS, Dombeck CB, Bruner DW, Keefe FJ, Weinfurt KP. Development of the NIH PROMIS (R) Sexual Function and Satisfaction measures in patients with cancer. J Sex Med. 2013 Feb;10 Suppl 1(0 1):43-52. doi: 10.1111/j.1743-6109.2012.02995.x.

  PMID: 23387911 BACKGROUND

• LP S. Stata 16 Base Reference Manual. College Station, TX: Stata Press, 2019.

  BACKGROUND

• Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. 2nd ed. New York: Wiley; 2002.

  BACKGROUND

• Gutierrez R. Parametric frailty and shared frailty survival models. Stata Journal 2002; 2: 22-44

  BACKGROUND

• Hernan MA, Robins JM. Estimating causal effects from epidemiological data. J Epidemiol Community Health. 2006 Jul;60(7):578-86. doi: 10.1136/jech.2004.029496.

  PMID: 16790829 BACKGROUND

• Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015 Dec 10;34(28):3661-79. doi: 10.1002/sim.6607. Epub 2015 Aug 3.

  PMID: 26238958 BACKGROUND

• Rosenbaum PR. Model-Based Direct Adjustment. Journal of the American Statistical Association 1987; 82(398): 387-94

  BACKGROUND

• Hirano K, Imbens GW. The propensity score with continuous treatments. In: Gelman A, Meng XL, eds. Applied Bayesian Modeling and Causal Inference from Incomplete-Data Perspectives. West Sussex, England: Wiley; 2004.

  BACKGROUND

• Strobl C, Malley J, Tutz G. An introduction to recursive partitioning: rationale, application, and characteristics of classification and regression trees, bagging, and random forests. Psychol Methods. 2009 Dec;14(4):323-48. doi: 10.1037/a0016973.

  PMID: 19968396 BACKGROUND

• StataCorp LP. Stata Survey Data Reference Manua, Release 14. College Station, Texas, 2015.

  BACKGROUND

• Keith RE, Crosson JC, O'Malley AS, Cromp D, Taylor EF. Using the Consolidated Framework for Implementation Research (CFIR) to produce actionable findings: a rapid-cycle evaluation approach to improving implementation. Implement Sci. 2017 Feb 10;12(1):15. doi: 10.1186/s13012-017-0550-7.

  PMID: 28187747 BACKGROUND

• Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, Burroughs H, Jinks C. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi: 10.1007/s11135-017-0574-8. Epub 2017 Sep 14.

  PMID: 29937585 BACKGROUND

• Bernard HR, Ryan GW. Analyzing Qualitative Data: Systematic Approaches. Thousand Oaks, CA: SAGE Publication, Inc. ; 2010.

  BACKGROUND

• Slinger G, Trautvetter L, Browning A, Rane A. Out of the shadows and 6000 reasons to celebrate: An update from FIGO's fistula surgery training initiative. Int J Gynaecol Obstet. 2018 Jun;141(3):280-283. doi: 10.1002/ijgo.12482. Epub 2018 Apr 10.

  PMID: 29634084 BACKGROUND

• El Ayadi AM, Obore S, Kirya F, Miller S, Korn A, Nalubwama H, Neuhaus J, Getahun M, Eyul P, Twine R, Andrew EVW, Barageine JK. Identifying opportunities for prevention of adverse outcomes following female genital fistula repair: protocol for a mixed-methods study in Uganda. Reprod Health. 2024 Jan 4;21(1):2. doi: 10.1186/s12978-023-01732-7.

  PMID: 38178156 DERIVED

• El Ayadi AM, Obore S, Kirya F, Miller S, Korn A, Nalubwama H, Neuhaus J, Getahun M, Eyul P, Twine R, Andrew EVW, Barageine JK. Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair: Protocol for a Mixed-Methods Study in Uganda. Res Sq [Preprint]. 2023 May 5:rs.3.rs-2879899. doi: 10.21203/rs.3.rs-2879899/v1.

  PMID: 37205399 DERIVED

MeSH Terms

Conditions

Fistula; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Alison El Ayadi, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: May 20, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)