Development and Pilot Test of a Multi-Component Intervention to Support Women's Recovery from Female Genital Fistula.

INTRODUCTION AND HYPOTHESIS: We evaluated a pilot multi-component reintegration intervention to improve women's physical and psychosocial quality of life after genital fistula surgery. METHODS: Twelve women undergoing fistula repair at Mulago Specialized Women and Neonatal Hospital (Kampala, Uganda) anticipated in a 2-week multi-component intervention including health education, psychosocial therapy, physiotherapy, and economic investment. We assessed feasibility through recruitment, retention, and adherence, acceptability through intervention satisfaction, and preliminary effectiveness through reintegration, mental health, physical health, and economic status. We collected quantitative data at enrollment, 6 weeks, 3 months, and 6 months. We conducted in-depth interviews with six participants. Quantitative data are presented descriptively, and qualitative data analyzed thematically. RESULTS: Participants had a median age of 34.5 years (25.5-38.0), 50% were married/partnered, 42% were separated, 50$ had completed less than primary education, and 67% were unemployed. Mean number of sessions received was 12 for health education (range 5-15), 8 for counseling (range 8-9), and 6 for physiotherapy (range 4-8). Feasibility was demonstrated by study acceptance among all those eligible (100%); comfort with study measures, data collection frequency and approach; and procedural fidelity. Acceptability was high; all participants reported being very satisfied with the intervention and each of the components. Participant narratives echoed quantitative findings and contributed nuanced perspectives to understanding approach and content. CONCLUSIONS: Our results suggest that the intervention and associated research were both feasible and acceptable, and suggested certain modifications to the intervention protocol to reduce participant burden. Further research to determine the effectiveness of the intervention above and beyond surgery alone with regard to the health and well-being of women with fistulas is warranted.

A digital health program for treatment of urinary incontinence: retrospective review of real-world user data.

INTRODUCTION AND HYPOTHESIS: To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users. METHODS: This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020-December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired t-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups. RESULTS: Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22-84, N = 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m2 (range 15.2-46.9, N = 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (p ≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified. CONCLUSIONS: This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.

Use of a motion-based digital therapeutic in women with fecal incontinence: A pilot study.

AIMS: There is limited data addressing the value of vaginal biofeedback (VBF) on fecal incontinence (FI) symptoms. The objective of this pilot study was to evaluate whether use of a motion-based VBF device and app was effective for at-home treatment of women with FI. We hypothesized that VBF would result in improvement in FI symptoms. METHODS: A single-arm 10-week prospective pilot trial in women with FI was conducted using the VBF device. The primary outcome was change in St. Mark's score from baseline to week 10. Secondary outcomes included change in 2-week bowel diary and FI quality of life (FIQoL). Statistical analysis included paired t test and Wilcoxon's signed-rank test. RESULTS: Of 29 enrolled women, 27 had data available for analysis. Mean (±SD) age was 60.9 (±14.4). 63% (17) subjects were White, 33% (9) were Black. Mean St. Mark's score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10-weeks (p = 0.005). Changes in the total FIQol, and three of four subsets of the FIQoL scores were also significantly improved (p < 0.001). Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052). CONCLUSIONS: In this pilot study, there was significant improvement in FI symptom-specific severity and quality of life using a vaginal, motion-based device for biofeedback. A larger study is needed to better understand the value of this device, which may be useful for women who prefer a vaginal device, which can be utilized at home compared with standard anal biofeedback for treatment of FI in the clinical setting.

Adherence to professional society guidelines among women with stress or mixed urinary incontinence.

AIMS: The objective of this analysis was to describe longitudinal adherence with recommended urinary incontinence (UI) evaluation and treatment guidelines over a 2-year period in patients newly diagnosed with stress (SUI) or mixed UI (MUI), and average 2-year cost associated with initial treatment. METHODS: A retrospective claims analysis using the IBM MarketScan database was conducted. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using the International Classification of Diseases (ICD) 9 and 10 codes for SUI or MUI. Newly diagnosed SUI/MUI patients who did not have a UI-related diagnosis for at least 1 year before their index date were assessed. RESULTS: 103 813 patients with newly diagnosed SUI or MUI were identified. Of those, 96.15% (99 821/103 813) received an initial evaluation in accordance with professional guidelines (e.g., patient history, physical examination, urinalysis). Only 6.8% (5086/74 925) and 7.7% (2229/28 888) of patients with SUI and MUI, respectively, received a first-line behavioral treatment (e.g., pelvic floor muscle exercises, bladder training), according to guidelines. The 2-year average UI-related medical costs associated with guideline adherence for SUI were $5770.93 ± $9454.81 and for MUI, $4416.16 ± $7401.53. Nonadherence was observed in 59.2% (44 382/74 925) of SUI and 64.1% (18 530/28 888) of MUI patients. Two-year average UI-related medical costs for the nonadherent group were $8568.00 ± $11 275.52 for SUI and $6986.66 ± $10 765.55 for MUI, significantly more than the adherent group (p < 0.0001). CONCLUSION: The majority of SUI or MUI patients do not receive a documented behavioral intervention as their first-line treatment, which is a recommendation by professional society guidelines. This was found to affect the cost burden for payers; those that were nonadherent had significantly higher costs 2-year postindex.

Retrospective claims analysis of physical therapy utilization among women with stress or mixed urinary incontinence.

OBJECTIVE: To describe the characteristics of women with stress or mixed urinary incontinence (SUI/MUI) receiving physical therapy (PT) services, including referral patterns and PT utilization. METHODS: Female patients with claims associated with an SUI or MUI diagnosis (International Classification of Disease-Clinical Modification [ICD-9-CM]: 625.6, 788.33, or ICD-10-CM: N39.3, N39.46) between July 01, 2014 and June 30, 2016 were identified in International business machines (IBM)'s MarketScan Research Database. Inclusion criteria included the absence of pregnancy claims and ≥80% medical and pharmacy enrollment pre- and postindex. First SUI/MUI diagnosis claim determined index. Patients were followed for 2 years, and associated UI-associated PT encounters were identified. Descriptive statistics were calculated for patients with at least one PT visit during the postindex period. RESULTS: In a cohort of 103,813 women with incident SUI or MUI diagnosis, 2.6% (2792/103,813) had at least one PT visit in the 2 years following their diagnosis. Mean age at index PT encounter was 50.55 years. A total of 52.36% (1462/2792) women had one to four PT visits; 21.2% (592/2792) had >8 PT visits. In subanalysis of the PT cohort (1345/2792), women who received PT only had the lowest average 2-year postindex total medical cost (mean: $12,671; SD: $16,346), compared with PT plus medications (mean: $27,394; SD: $64,481), and PT plus surgery (mean: $33,656; SD: $26,245), respectively. Over 40% had their first PT visit ≥3 months after their index date. CONCLUSIONS: The percentage of women with a PT visit associated with an incident SUI or MUI diagnosis was low (2.6%), and 30% of this group completed three or more PT visits. This suggests poor adherence to clinical guidelines regarding supervised treatment of UI in women. IMPACT STATEMENT: Our study suggests underutilization of PT among insured women with SUI and MUI in the 2 years following diagnosis. Interventions to improve this gap in first-line care may represent an opportunity for an increased role for PTs in the care of women with UI.

Rehabilitative care practices in the management of childbirth-related pelvic fistula: A systematic review.

INTRODUCTION AND HYPOTHESIS: Childbirth-related pelvic fistula (CRF) often requires surgery, yet even with successful repair, mental health conditions, musculoskeletal impairments, urinary and fecal incontinence and sexual dysfunction persist for many women. Postoperative rehabilitation, (i.e., physiotherapy, mental health counseling) may address these concerns and has been reported for this population. This review aims to summarize the literature and level of evidence of rehabilitative care practices in fistula care to inform clinical practice, research and policy recommendations. METHODS: A systematic literature review was conducted using Africa-Wide Information, CINAHL, Cochrane, Embase, Global Health, PAIS Index, PubMed and SCOPUS searching keywords and MeSH terms to identify women with CRF admitted for surgery. Two researchers progressively screened titles, abstracts and full-text articles. Eligible articles were classified primary if intervention details and outcomes were reported or secondary if rehabilitation was described, but no specific outcomes reported. Relevant study details, strengths and limitations, and key findings were extracted. RESULTS: Eighteen articles were included: eight primary, ten secondary. Primary articles reported on urethral plugs for postoperative urinary incontinence (UI) (2/8), menstrual cup to manage UI (1/8), physiotherapy and health education (3/8) and mental health counseling (2/8). Secondary articles describe rehabilitation components in the context of program descriptions, qualitative analyses or reviews. All evidence was low or very low quality. CONCLUSIONS: Research on rehabilitative care is very limited and highlights inconsistencies in practice. This review provides support for the feasibility of rehabilitation and establishes the need for future interventional studies that involve a comparator and reliable outcome measures.

Prevalence of urinary incontinence in pregnant and postpartum women in the Democratic Republic of Congo.

INTRODUCTION AND HYPOTHESIS: The objective was to describe the prevalence of urinary incontinence in pregnant and postpartum women in the Democratic Republic of Congo and to identify factors associated with urinary incontinence (UI) in these populations. METHODS: We interviewed eligible women who sought prenatal or postnatal reproductive health clinic consultations over a 2-year period. Interviews collected information about demographics, obstetric history, and urinary incontinence symptoms, as well as the impact on the quality of life, via a validated questionnaire. Descriptive analyses compared women with and without urinary incontinence and compared characteristics of UI, stratified by pregnancy status. Logistic regression identified factors associated with UI among the entire sample, pregnant women, and postpartum women. RESULTS: Overall, 268 out of 880 women had UI (30.5%); the prevalence was 33.4% (168 out of 503) among pregnant women and 26.5% (100 out of 377) among postpartum women, p = 0.03. Women who were pregnant were significantly more likely to experience stress incontinence (p = 0.01) and less likely to report moderate or large amounts of leakage (p = 0.002). A history of macrosomia and being currently pregnant were associated with UI in the entire sample (p < 0.05). Among pregnant women, the risk of UI decreased with increasing gestational age and increased with a history of macrosomia (p ≤ 0.01). Among postpartum women, a history of macrosomia and prior episiotomy were associated with UI (p < 0.05). CONCLUSIONS: Urinary incontinence is prevalent in pregnant and postpartum women in the Democratic Republic of Congo and is associated with a history of macrosomia. Efforts should focus on screening, evaluation, and treatment.

Development of a wireless accelerometer-based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction.

Urinary incontinence (UI) is experienced by an estimated 51% of women in the U.S. and often results from impaired function or weakening of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a frontline nonsurgical treatment, yet a number of symptomatic individuals cannot accurately perform a pelvic floor muscle contraction with simple verbal or written instruction. Long-term adherence to PFMT regimens is often a barrier to resolution of symptoms. Various biofeedback tools have been utilized to aid correct pelvic floor muscle performance and adherence. One novel device, the leva® Pelvic Digital Health System, utilizes an intravaginal probe embedded with MEMS accelerometer sensors that allow real-time visualization of the shape and motion of the vagina during PFMT. Early positive results with this device prompted design of a wearable version. The purpose of this study was to design a wearable, wireless clinical research device to optimize MEMS accelerometer sensor placement to detect maximal movement during a pelvic floor muscle exercise (PFME) and to test the form factor for retention and user acceptability. The device comprised a ring designed to sit at the fornix with an extension following the length of the vagina. This paper presents design components and results from clinical testing of 10 subjects. It was determined that a ring form factor alone, similar to other vaginal rings (pessaries, estrogen rings) provided less accurate visual information about PFME performance. By contrast, we determined that a ring with an extension allowed for device retention and improved real-time detection of vaginal shape and motion during PFMT.

Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.

BACKGROUND: Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women's access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale. OBJECTIVE: The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success. METHODS: This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis. RESULTS: Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated. CONCLUSIONS: This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.

Violence Against Women - A Global Perspective.

Gender-based violence (GBV) affects more than 700 million women and girls, worldwide, manifesting systemically (eg, human trafficking) and at the interpersonal level (eg, rape, intimate partner violence) and conveying significant negative economic, social, mental, and physical health impacts. It is important for the clinician to be prepared for providing emergency, urgent, and longer-term care to women who are survivors of GBV. Panzi Hospital in the Democratic Republic of the Congo provides an example of person-centered, holistic care for survivors of GBV, including conflict-related and nonconflict-related sexual violence.

Female Urinary Incontinence Evidence-Based Treatment Pathway: An Infographic for Shared Decision-Making.

Objectives: Urinary incontinence (UI) is a highly prevalent burdensome condition among adult females in the United States, yet rates of care-seeking, evaluation, and treatment are nonoptimal. Components of evaluation and treatment are informed by research and professional society guidelines; however, a visual representation of this guidance does not exist. The objectives of this study are to review the literature regarding female UI care and to synthesize this information into a graphical format to facilitate health education, health care delivery, and shared decision-making. Methods: We reviewed published society guidelines, position statements, and associated references from the American College of Obstetrics and Gynecology, the Women's Preventive Services Initiative, American Academy of Family Physicians, American College of Physicians, the Society of Urodynamics and Female Urology, the American Urological Association, and the American Urogynecologic Society, and searched PubMed for related literature. We synthesized these findings into an evidence-based infographic depicting female UI risk factors, influences on care-seeking and provision, screening, evaluation, and a stepwise treatment approach. Results: This study summarizes current evidence and professional guidelines related to female UI into a compelling visual format and accompanying narrative. The infographic is intended as a tool for patient education, clinical practice, and research to facilitate shared decision-making and health care delivery. Conclusions: Female UI is highly prevalent, yet diagnosis and treatment are suboptimal. Use of an evidence-based infographic may positively impact patient knowledge and certainty about UI treatment and support health care provider counseling and decision-making.

Function and disability status among women with fistula using WHODAS2.0: A descriptive study from Rwanda and Democratic Republic of Congo.

OBJECTIVE: To assess function and disability among women in Rwanda and Democratic Republic of Congo living with fistula and identify characteristics associated with higher disability scores. METHODS: Women presenting for fistula care were recruited. Eligible participants underwent a physical examination to classify fistula type and completed the WHO Disability Assessment Schedule 2.0 questionnaire to ascertain the impact of fistula on function across six domains: cognition, mobility, self-care, getting along, life activities, and participation. Disability scores were calculated (where 0 = no disability and 100 = complete disability). Participants were grouped according to no, low, or high disability status; results were examined to determine the domains most affected. RESULTS: Among 69 participants, fistula type included: vesicovaginal (59.4%), ureterovaginal (14.5%), total absence of proximal urethra (11.6%), and rectovaginal (14.5%). Median disability score was 43.0/100 (interquartile range 26.0-67.0); 83% exhibited high disability status. Life activities and participation in society domains were most affected. Women with rectovaginal fistula reported the lowest scores, and those with total absence of proximal urethra reported the highest scores. CONCLUSION: WHO Disability Assessment Schedule 2.0 represents a simple, robust measure of global disability status, aligns with research efforts to estimate maternal disability, and may inform health needs and resource allocation for this population. In this study, disability was common, varied by fistula type, and affected physical, mental, and social domains.

Sports-related injuries in youth athletes: is overscheduling a risk factor?

OBJECTIVE: To examine the association between "overscheduling" and sports-related overuse and acute injuries in young athletes and to identify other potential contributing factors to create a working definition for "overscheduling injury." DESIGN: Survey. SETTING: Six university-based sports medicine clinics in North America. PARTICIPANTS: Athletes aged 6 to 18 years (13.8 ± 2.6) and their parents and pediatric sports medicine-trained physicians. INTERVENTIONS: Questionnaires developed from literature review and expert consensus to investigate overscheduling and sports-related injuries were completed over a 3-month period. MAIN OUTCOME MEASURES: Physician's clinical diagnosis and injury categorization: acute not fatigue related (AI), overuse not fatigue related (OI), acute fatigue related (AFI), or overuse fatigue related (OFI). RESULTS: Overall, 360 questionnaires were completed (84% response rate). Overuse not fatigue-related injuries were encountered most often (44.7%), compared with AI (41.9%) and OFI (9.7%). Number of practices within 48 hours before injury was higher (1.7 ± 1.5) for athletes with OI versus those with AI (1.3 ± 1.4; P = 0.025). Athlete or parent perception of excessive play/training without adequate rest in the days before the injury was related to overuse (P = 0.016) and fatigue-related injuries (P = 0.010). Fatigue-related injuries were related to sleeping ≤6 hours the night before the injury (P = 0.028). CONCLUSIONS: When scheduling youth sporting events, potential activity volume and intensity over any 48-hour period, recovery time between all training and competition bouts, and potential between-day sleep time (≥ 7 hours) should be considered to optimize safety. An overscheduling injury can be defined as an injury related to excessive planned physical activity without adequate time for rest and recovery, including between training sessions/competitions and consecutive days.

Prenatal care counseling and delivery method among women with multiple Cesareans: A cross-sectional study from Democratic Republic of Congo.

Prenatal care (PNC) and counseling about delivery method is an important strategy to prevent delivery complications among women with multiple prior Cesarean sections (CS). In low income countries, an elective CS is recommended for this population. This cross-sectional study examined factors associated with counseling about delivery method and its influence on the likelihood of an elective CS delivery. A total of 422 women with ≥2 prior CS who delivered across five hospitals in Democratic Republic of Congo (DRC) were interviewed about PNC and counseling. Descriptive statistics and multivariate regression were completed to ascertain factors associated with counseling. Only 33.6% delivered via planned CS; 60.7% required an emergency CS. One-quarter completed four PNC visits; 64.5% received counseling. Number of PNC visits and number of prior CS were significant predictors of receipt of counseling. Women who received ≥2 PNC visits were 2.2 times more likely to have received counseling (p = 0.000). Among women who received counseling, 38.6% had a planned CS compared with 24.7% in the non-counseled group. Counseling was associated with mode of delivery; emergency CS and vaginal delivery were more frequent among women who did not receive counseling (p = 0.008). These findings highlight the importance of counseling during PNC visits. This study also highlights the poor coverage and quality of counseling in this high-risk population and the need for improvements in PNC. Less than 40% of counseled women followed provider recommendations for a planned delivery via CS. The majority labored at home and later delivered emergently. The significant number of women who trial labor without medical supervision despite their high-risk status sheds light on the influence of patient perceptions about CS and acceptance of medical intervention during birth.

The mobile surgical outreach program for management of patients with genital fistula in the Democratic Republic of Congo.

OBJECTIVE: To describe components of the mobile surgical outreach (MSO) program as a model of care delivery for women with genital fistula; present program results; and discuss operational strengths and challenges. METHODS: A retrospective observational study of routinely collected health data from women treated via the MSO program (2013-2018). The program was developed at Panzi Hospital in the Democratic Republic of Congo to meet the needs of women with fistula living in remote provinces, where travel is prohibited. It includes healthcare delivery, medico-surgical training, and community sensitization components. RESULTS: The MSO team cared for 1517 women at 41 clinic sites across 18 provinces over the study period. Average age at presentation was 31 years (range, 1-81 years). Most women (n=1359, 89.6%) presented with vesicovaginal fistula. Most surgeries were successful, and few women reported residual incontinence postoperatively. Local teams were receptive and engaged in clinical skills training and public health education efforts. CONCLUSION: The MSO program addresses the backlog of patients awaiting fistula surgery and provides a template for a national strategic plan to treat and ultimately end fistula in DRC. It offers a patient-centered approach that brings medico-surgical care and psychosocial support to women with fistula in their own communities.

Analysis of a pilot program to implement physical therapy for women with gynecologic fistula in the Democratic Republic of Congo.

OBJECTIVE: To describe components of a physical therapy pilot program for women with gynecologic fistula, and to report prospective data from the first 2 years of program implementation. METHODS: A single-cohort observational study with repeated measures was conducted at HEAL Africa Hospital, Goma, Democratic Republic of Congo. Hospital staff received training in pelvic floor physical therapy. Guidelines for exercise, functional training, and reproductive health education were integrated into the existing program. Demographics, clinical findings, and functional outcomes were recorded. Key stakeholders were interviewed to understand the perceived strengths and limitations of the program. RESULTS: A total of 205 women were followed up; 161 participated in physical therapy, with an average of 9.45 sessions. Of 161 women examined postoperatively, 102 (63.4%) reported no incontinence; they remained continent at discharge. Of 21 who indicated a change in level of incontinence during postoperative physical therapy, 15 (71.4%) improved. The program was feasible and well received by staff and patients. CONCLUSION: Pelvic floor physical therapy could have significant results in women with gynecologic fistula, may be an important adjunctive treatment in comprehensive fistula care, and warrants further investigation.