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. 2020 Jan 13;148(Suppl 1):42–58. doi: 10.1002/ijgo.13039

Table 2.

Study details, published literature

Study (author/year) Article type Study objective Country Study design Study dates Participants Intervention description (summary, location, duration, mechanism, structure, comparison) Study outcomes and measures Results Recommendations (authors’ recommendations based on findings/experiences)
Castille et al.38, 39 (2014 and 2015) Empirical research To measure the impact of a physiotherapy and health education intervention on surgical repair outcomes Benin Quasi‐experimental (nonrandomized control and pre/post)

Control: Nov. 2009–Jan. 2011

Intervention: Mar. 2011–Mar. 2012

1‐yr follow‐up: Mar 2012–Mar 2013

14 d: 211 women with VVF (112 intervention, 99 control) 1 yr: 84 women in intervention group, not lost to follow‐up Summary of components: Health education and physiotherapy Location: Fistula repair camp Implementer: physiotherapists, nurses (follow‐up) Duration: Preoperative through 14 d postsurgery Mechanism: Maintain low abdominal pressure through activity modification Structure: Preoperative: 2–3 physiotherapist‐led didactic sessions to learn techniques to reduce abdominal pressure during daily activities including perineal contractions, hypopressive exercises, and behavioral instruction. Postoperative: Further physiotherapy sessions. Activity prohibitions for 3 mo: sitting up from back lie, twisting body, bending at abdomen, lifting with bend in back, sexual intercourse. Socially isolated women offered vocational training and/or microcredit (no additional detail). Follow‐up at 3, 6, and 12 mo (unclear if any additional instruction offered). Comparison: standard of care (no follow‐up) 14 d: Repair success (fistula repaired with or without incontinence vs failed repair or urinary diversion) 1 yr: Quality of life (QOL; Ditrovie scale, range 10–50) Repair success (14 d): Repair success was significantly higher in intervention group (68.8% vs 57.6%; OR 2.72, 95% CI, 1.30–5.93, P=0.005). Number of prior surgeries also significant predictor of surgical repair success. Among women with closed fistula, urinary stress incontinence was lower in intervention group (52.6% vs 22.1%, P<0.001) Repair success (1 yr): Among women with failed repair, 3/29 were healed after 1 yr. Among women with successful repair and USI, 6/17 had no USI at 1 yr. Among women with successful repair and no USI, 2/60 had fistula recurrence and 4/60 developed USI Quality of life (1 yr): Mean QOL at surgery through 1 yr decreased from 36.3 to 13.0 among women with successful surgery and no USI, from 34.3 to 17.0 among women with successful surgery and USI, and from 38.7 to 29.4 among women with failed repair (including 10.3% who had achieved repair by 1 yr) Health education and simple physiotherapy including pelvic floor training and abdominal wall management can reduce surgical failures and improve surgical repair outcomes for women with VVF. Positive impact was maintained for 1 yr following surgery, with substantial improvements in QOL. Overall care of women with be improved by adequate nursing and support by a trained physiotherapist
Johnson et al.25 (2010) Empirical research To assess the impact of a health education and psychosocial counseling program on fistula knowledge, self‐esteem, and behavioral intentions following surgery Eritrea Quasi‐experimental (pre/post) Feb.–Mar. 2006 43 women seeking fistula repair Summary of components: Health education and psychosocial counseling Location: Health facility Implementer: Nurses and public health workers Duration: 4 d (1 d preoperative through 3 d postoperative) Mechanism: Educating clients about fistula and prevention, building their self‐esteem and helping to prepare them for social reintegration will increase awareness about women's bodies, prevent postsurgical complications, and contribute to fistula prevention Structure: 2 individual counseling sessions (1 preop, 1 postop). Preoperative: counseling on fistula causes and prevention, stories of other women with fistula, client's specific fistula type and surgery, treatment scope and anticipated outcomes, postoperative recovery expectations, operative and postoperative complications, encouragement to consider life and health goals following repair. Postoperative: counseling on patient postop condition management, options if repair is unsuccessful, reproductive health and rights, family planning, personal hygiene, nutrition, medical follow‐up, community and familial reintegration, encouragement to share information with women in home community on fistula and safe motherhood, ideas about how to share information with others on fistula and fistula prevention Comparison: Not applicable Fistula knowledge, self‐esteem (range 0–30), and behavioral intentions for health maintenance and social reintegration Focus groups (2, with 19 total clients) to explore patient experiences with surgical care and counseling Fistula knowledge: significant increases in knowledge of what fistula is (45.7% to 79.1%), what causes fistula (fistula caused by lack of SBA 34.8%to 88.4%), whether fistula is preventable (strongly agreed preventable 37.0% to 90.7%, agreement with 4 + ways to prevent fistula 52.2% to 90.7%), and knowledge about surgical risks (19.6% to 51.2) Self‐esteem: significant increase in mean self‐esteem score (13.6 to 27.9) Behavioral intentions after surgery: significant increases in intent to use family planning (0.0%to 33.3%), intent to improve hygiene (13.0% to 44.2%), intent to improve nutrition (17.4% to 58.1%), plan to talk to family members about fistula (26.1% to 90.7%), and plan to talk to community members about fistula (34.8% to 76.7%) Qualitative findings: women felt prepared for what to expect for surgery after preoperative counseling, and shared that they felt better about themselves and their futures following treatment and counseling. Several women felt their family members should be counseled on fistula and fistula prevention A formal counseling program can have significant positive short‐term impact on fistula patients through increasing knowledge about fistula and improving self‐esteem. Counseling programs should involve family members and provide information on and access to family planning methods
Keyser et al.,40 Keyser et al.41 (2014) Empirical research To describe components of a physical therapy for women with fistula and report on outcomes Democratic Republic of Congo Quasi‐experimental (pre/post) May 2010–April 2012 205 total, 142 with discharge evaluation Summary of components: Health education and physiotherapy Location: Health facility Implementer: Physical therapists and nurses Duration: 7–14 d of physical therapy, average of 9.45 sessions Mechanism: Educating clients about fistula and prevention, building their self‐esteem and helping to prepare them for social reintegration will increase awareness about women's bodies, prevent postsurgical complications, and contribute to fistula prevention Structure: Physical therapy sessions started at day 14 postoperatively Comparison: Postsurgery compared with hospital discharge Pelvic floor muscle strength (range 0–5), contraction endurance (contraction time), contraction repetitions, fast contractions, level of continence (self‐report, Addis Ababa Fistula Hospital Incontinence Scale; range 1–5). Pelvic floor muscle strength: mean 2.45 postop to 2.54 at discharge, with 17.6% improving in grade Contraction endurance: mean 1.83 postop to 2.25 at discharge, with endurance improving among 45.5% and worsening among 5.6% Contraction repetitions: mean 5.40 postop to 8.75 at discharge Fast contractions: 24.6% had change in number of fast contractions, with 21.8% improving and 2.8% worsening Incontinence: 63.4% had no incontinence at discharge. 21 women had change in reported continence level postop to hospital discharge; of these, 71.4% improved and 28.6% worsened (all those who worsened had repair failure) Preliminary results suggest that integrated physical therapy for women undergoing fistula repair is feasible and may be an important adjunct treatment given observed improvements in pelvic floor functional capacity with limited exposure to physical therapy. Challenges to implementation included need for more support and continuing education in pelvic floor physical therapy, difficulty in following patients long term, high staff turnover, and limited funding for program continuation
Ojengbede et al.24 (2014) Empirical research To determine the impact of group psychological therapy on the mental health of obstetric fistula patients South Sudan Quasi‐experimental (pre/post) Oct.–Nov. 2008 60 women Summary of components: Health education and psychosocial counseling Location: Fistula camp Implementer: Trained nurse psychologist or clinical counselor Duration: 1 session Mechanism: Group interpersonal therapy among patients with similar mental health conditions helps patients to understand their health problems through sharing of information, experiences, and coping strategies Structure: Group sessions had 9–12 participants and lasted 45–60 min. Discussion topics included the cause of their health challenge, initial reaction of their family members and community to incontinence, how they have been able to live and interact with their community, and the emotional impact. Counselors guided participants to think of ways to solve problems. Sessions concluded with fistula education and dispelling myths Comparison: Presurgery compared with hospital discharge (14–21 d postoperative) Depression, self‐esteem, and suicidal ideation Depression: Depression significantly decreased from 71.7% to 43.4% Self‐esteem: Very low self‐esteem significantly decreased from 65.0% to 18.3% Suicidal ideation: Severe suicidal ideation significantly decreased form 15% to 0%, and no suicidal ideation significantly increased from 43.3% to 73.3% Given the systematic reductions in all mental health measures after group psychological therapy, psychological counseling is recommended as an adjunct to surgical repair. Group psychotherapy offers the opportunity for individuals to share experience and coping strategies and is cost‐efficient in countries with limited human resources
Pollaczek et al.45 (2017) To describe holistic fistula outreach, treatment and reintegration program content Kenya Program report and postparticipation mixed‐methods evaluation Ongoing program; evaluation March 2012 40 support group members, with mean time since fistula surgery 2 y Summary of components: Psychosocial counseling, social support, and economic empowerment Location: Hospital and community Implementer: Psychologists/social workers (counseling) and community representatives Duration: Not specified. Mechanism: Economic empowerment will help women resume activities in community life and have greater agency and access to resources through: (1) challenging ideologies that justify social inequality; (2) changing prevailing patterns of access over resources; and (3) transforming institutions and structures that reinforce and sustain existing power structures Structure: Three‐pronged approach: (1) outreach/identification of women with fistula and referral to care; (2) surgical repair and psychosocial counseling; and (3) reintegration assistance. At repair hospitalization, women undergo 2–3 individual or group psychosocial counseling to help women work through anxieties. Women are then escorted home by program staff and linked to peer support groups. Groups provide psychosocial support, teaches income generating skills and women participate in group‐led income generation activities. Group participation increases access to bank accounts and microloans. Women and their families are enrolled in the Kenya National Hospital Insurance Fund Comparison: None Emotional well‐being, fistula knowledge, and economic status Well‐being: 90% reported support groups helped them a lot to make new friends, communicate with family members, and feel happy in lives Fistula cause: 85% indicated support groups helped them a lot to understand causes of fistula. Women in FGDs were able to articulate fistula causes and how to prevent recurrence after repair Economic status: 9% reported that they had been helped a lot with their basic needs, 64% said helped somewhat, and 23% said helped not very much. FGD participants reported success in developing income generating projects, getting larger loans out from the bank and respect in the community Fistula survivors trained to serve as community‐based representatives can effectively improve community awareness, increase identification of women with fistula and refer to surgical and psychological treatment, and provide meaningful reintegration assistance. A holistic integrated model of outreach, treatment, and reintegration can have a large impact on women's lives, physically and emotionally. In time, it may also help women financially. Such a group model may be most effective in areas where fistula is concentrated.
Trombley and McKay36 (2010) Program also reported on in Diallo37 (2009) Program report To describe fistula‐related programming in Guinea funded by USAID Guinea Program report Report on programming 2008–2010 Women with genital fistula attending Kissidougou repair hospital; no details provided Summary of components: Health education and social support Location: Community Implementer: Waiting home coordinator, host families Duration: Not specified Mechanism: Social immersion in nonjudgmental environments supports women's recovery and reintegration. Health education and communication skills will help women become agents of change in their communities Structure: Women stay in a waiting home for 2 wk prior to their surgery for testing and intake processes, and return to this waiting home after hospital discharge (14 d after surgery) until they have recovered. The coordinator supports patient morale and helps to create a sense of community at the waiting home. At the waiting home, women receive health education, orientation to publicly speaking, and interpersonal communication training. For women who have a longer recovery period or who would have difficulty returning for a 3‐mo postoperative check‐up, a host family initiative has been developed. Staying with a host family helps facilitate the transition between the waiting home and return to home villages, as women are able to participate in normal family activities to the extent to which they are comfortable Comparison: None Participant engagement in community educational sessions Participant community engagement: 53% of women who stayed at the waiting home had conducted at least 1 awareness session in communities Diallo: anecdotally, women experienced increased confidence, self‐esteem, and emotional health Waiting home model provides physical and social support to women. Greater attention is needed to address the psychosocial needs of patients and improve knowledge of host families. Other skills‐building or income‐generation activities would further facilitate patients’ reintegration; however, no funding is currently available for this
Watt et al. 42, 43 (2015), Watt et al.44 (2017) Empirical research To develop a mental health intervention for obstetric fistula patients, and pilot test for feasibility and acceptability Tanzania Intervention development and pilot study Feasibility/acceptability pilot: 2014 (not further specified) Pilot RCT: Mar 2014–June 2016 Feasibility/acceptability pilot: 6 fistula patients Pilot RCT: 60 women, 30 intervention, 30 control Summary of components: Psychosocial counseling and health education Location: Hospital Implementer: Trained community health nurse Duration: 6 individual psychotherapy sessions over a 2‐wk period (2 presurgery, 4 postsurgery) Mechanism: An intervention based on CBT and coping skills will lead to effective coping and improved mental health, further resulting in social well‐being and general functioning, and improving ability to reintegrate Structure: Session 1: Normalize patient's experience, acknowledge fistula impact, explore fistula influence on self‐perception, generate therapy goals, and learn relaxation exercise (to practice daily). Session 2: Practice relaxation exercise, review any other assignments, cognitively reframe fistula experience through education, counsel on fistula surgery, discuss treatment hopes/anxieties/questions. Patients assigned relaxation practice and asking healthcare provider questions. Session 3: Introduce to cognitive model, begin teaching how to reframe negative/unhelpful thoughts, teach ‘serenity prayer’ and relate to individual coping. Patient assigned relaxation practice and practice reframing negative thought. Session 4: Help patient recognize and respond to stressors using appropriate and effective coping skills, create behavioral plan for coping with negative stressors. Patient assigned coping strategy practice. Session 5: Examine the effect of social relationships on patient's life, generate specific strategies to strengthen social relationships, role play potential discussions about fistula, facilitate call between patient and support person to facilitate return home. Patient assigned consideration of thoughts and feelings about going home. Session 6: Prepare the patient to return home, discuss patient thoughts/emotions, problem solve how to handle circumstances and cope with potential stressors, develop a detailed action plan, facilitate second phone call with support person to share reintegration plans and solidify support, share summary of postsurgery medical recommendations (e.g. 3 mo of sexual abstinence, no heavy work), review goals, achievements, and plan Comparison: None (feasibility/acceptability pilot), standard of care (pilot RCT) Feasibility/acceptability pilot: Patient satisfaction with intervention, counselor, number of sessions, and time spent per session Pilot RCT: Patient satisfaction with intervention, counselor, number of sessions, and time spent per session, depression, anxiety, PTSD, self‐esteem

Feasibility/acceptability pilot: Satisfaction with intervention: 5/6 very satisfied; 1/6 satisfied Satisfaction with counselor: 6/6 very satisfied Satisfaction with number of sessions: 4/6 right amount, 2/6 too much Satisfaction with time spent per session: 4/6 right amount, 2/6 too much

Pilot RCT: Depression: Mean symptoms dropped from 25.9 to 12.4 in control and 22.1 to 9.9 in intervention from baseline to post‐treatment (n/s), and to 6.6 in control and 6.4 in intervention at 3 mo (n/s) Anxiety: Mean symptoms dropped from 10.8 to 2.6 in control and from 10.6 to 2.4 in intervention from baseline to post‐treatment (n/s), and to 1.0 in control and 2.1 in intervention at 3 mo (n/s) PTSD: Mean symptoms dropped from 38.8 to 31.1 in control and from 37.1 to 28.6 in intervention (n/s) from baseline to post‐treatment, and to 23.8 in control and 26.2 in intervention at 3 mo (n/s) Self‐esteem: Mean self‐esteem increased from 12.4 to 21.9 in control and 13.9 to 23.6 in control from baseline to post‐treatment, and to 24.0 in control and 25.0 in intervention at 3 mo (n/s) Satisfaction with intervention: 30/30 would take part again Satisfied with intervention: 96.7% Satisfied with intervention facilitator: 100% Satisfied with number of sessions: 80% (20% said too many) Satisfied with time spent at sessions: 76.7% (23.3 said too long)

Formative work to tailor and adapt psych theory was critical. Integration into clinical flow, and feasibility for using a nonspecialist mental health person. If this intervention should prove efficacious in a future randomized control trial, then scale up within fistula repair programs should be considered Women presenting for obstetric fistula surgery have high levels of distress. A nurse‐led mental health intervention is feasible and acceptable, with high rates of fidelity and was rated positively by participants. Successful surgical repair has a big outcome on postrepair mental health outcomes. The study potentially suggests that women with unsuccessful surgeries may particularly benefit from an intervention focused on cognitive reappraisal and coping behaviors, including the potential for home‐based follow‐up. Addressing the accumulated psychological and social effects provides holistic care

Abbreviations: VVF, vesicaovaginal fistula; USI, urinary stress incontinence; SBA, skilled birth attendant; FGD, focus group discussion; RCT, randomized controlled trial; CBT, cognitive behavioural therapy; PTSD, post‐traumatic stress disorder.