Introduction

Poor access to timely and quality obstetric care puts women in low-resource countries at a high risk for obstetric complications such as prolonged obstructed labor. Obstructed labor can lead to ischemic injury of the bladder and/or bowel, leading to fistula formation. Obstetric fistula is estimated to range from 1.2 per 1000 live births in South Asia to 1.60 per 1000 live births in sub-Saharan Africa. Within sub-Saharan Africa, Uganda has a high lifetime prevalence of women reporting symptoms consistent with the presence of a fistula (14 per 1000 women of reproductive age).

Obstetric vesicovaginal fistula repair has a generally favorable surgical outcome in the hands of skilled surgeons, with successful closure of the fistula in 87% to 93% of cases. The rate of closure is lower for less-experienced surgeons, and it is also influenced by other clinical risk factors such as previous unsuccessful fistula surgery or more extensive injuries. ^, In women who have had successful fistula closure, between 16% and 55% of them ^, may still experience chronic persistent urinary incontinence that severely impacts their quality of life. ^, This has been termed by some as “the continence gap.” Few studies have highlighted the prevalence of persistent post-fistula incontinence, and even fewer have investigated the type and severity of incontinence or its impact on women. In a large prospective cohort study of obstetrical fistula patients (N=401) from Malawi, researchers reported that Although 93% of women had successful closure of their fistula, 23% had persistent urinary incontinence. The risk factors for persistent incontinence included age, number of years living with fistula, number of previous attempts at fistula repair, and clinical characteristics of the fistula itself. In our own study in Ethiopia where we compared women with and without persistent urinary incontinence after successful fistula closure, women with incontinence tended to be younger and had developed their fistula with their first pregnancy. They reported both stress (98%) and urgency (94%) incontinence, and nearly half reported constant urinary leakage with significant impact on their quality of life. We hypothesized that these observations would be similar in other populations suffering from obstetric fistula.

This article draws from a mixed-method, community-led project run by TERREWODE, a Ugandan nongovernmental organization (NGO) that has been providing clinical and social reintegration services for fistula victims since 2001. This study aimed to better understand the type, severity, and impact of persistent incontinence following successful fistula closure in Ugandan women. An additional aim of this project was to test two novel low-technology tools created for use with low-literacy populations suffering from urinary incontinence.

Materials and Methods

This was a cross-sectional study conducted in central and eastern Uganda between October 2017 and May 2019. Ethical approval was obtained from the institutional review boards at Makerere University School of Public Health (Kampala, Uganda), Uganda National Council of Science and Technology, and Oregon Health & Sciences University (Portland, OR). The study participants were screened and recruited by staff from TERREWODE. Translators, who are also trained fistula counselors, obtained consent using documents that had been translated into three local languages (Ateso, Kumam, and Lugandan). The study questionnaires were administered by the last author (B.R.) with the assistance of the female TERREWODE translators. The inclusion criteria involved women having a history of previous obstetric fistula repair who were between the ages of 18 and 80 years old. The exclusion criteria included women with clinically-proven obstetric fistulas who were younger than 18 years or older than 80 years, were currently pregnant, had a current urinary tract infection, or who had a history of urinary diversion surgery. Women who qualified for the study were divided into cases (women with successfully closed fistula who report persistent urinary incontinence) and controls (women with successfully closed fistula who did not report persistent urinary incontinence).

The cases were clinically evaluated by a fistula surgeon to confirm the absence of a current fistula. This was done using a standard clinical technique, in which the bladder was filled through a small transurethral catheter with 200 to 300 mL of sterile saline colored with methylene blue dye. The catheter was then clamped, and the vagina was examined with the patient in the lithotomy position. Patients with a documented unclosed fistula were excluded from the study and were directed to a fistula surgeon for further care. Following the dye test, the catheter was removed, and a cough stress test was performed with a full bladder with the patient in a standing position.

All the participants completed a semistructured demographic and psychosocial questionnaire. The cases also participated in an in-depth interview; an analysis of the qualitative findings are forthcoming. The cases completed a series of urinary incontinence- specific questionnaires, including the validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) to assesses the frequency, volume of loss, and impact of urinary incontinence. The severity of incontinence, as captured by the ICIQ-SF, was categorized into grades: slight (scores ranging from 1–5), moderate (6–12), severe (13–18), and very severe (19–21). The cases also completed the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life questionnaire (ICIQ-LUTSqol) to assess the impact of urinary incontinence on their quality of life. ^,

In addition, the cases completed two novel low-technology tools designed for use with low-literacy populations having incontinence. The first tool—the Post-Fistula Incontinence Severity Scale (PFISS) —is designed to assess the perceived severity of a patient’s incontinence after successful surgical fistula closure using a pictorial questionnaire. The cases were shown culturally-appropriate pictures of a woman experiencing varying levels of incontinence and were asked to choose the picture that matched their experience. They also completed a 24-hour-voiding diary modified for use in low-literacy populations. The women recorded their voiding and incontinence episodes over 24 hours using a paper-strip method. They were provided with a large envelope containing strips of white and pink colored paper affixed to the envelope (∼2×40 cm). They were instructed to tear off a small piece of white paper every time they voided and to tear off a small piece of pink paper every time they leaked urine. The strips of paper were then placed into the envelope. The envelopes were collected 24 hours later, and the strips of paper were categorized and counted to document the frequency of voids and urinary incontinence.

The data were analyzed using Stata (version 15; StataCorp, College Station, TX). Cases and controls were compared using independent two-sample t tests (continuous data) and the Chi-square test or Fisher exact test (categorical data). Continuous data are presented as mean±standard deviation (SD) after checking for normality; the categorical data are presented as frequency and percentage. We reported the average (SD) for International Consultation on Incontinence Modular Questionnaire-Quality of Life (ICIQ-QoL) and PFISS and frequency (percentage) for categories of ICIQ-SF. The Spearman rank correlation coefficients were calculated between ICIQ-SF & ICIQ-QoL, between ICIQ-SF and PFISS, and between ICIQ-QoL & PFISS. Values between 0.4 and 0.6 were considered as moderate correlation.

We utilized three multivariable logistic regression models. First, we assessed the predictors of post-fistula incontinence. Our primary outcome was post-fistula incontinence as evaluated using the ICIQ-SF questionnaire. We utilized binary variables (moderate to severe incontinence [8–18 scores] and very severe incontinence [19–21 scores]). Confounders were chosen on the basis of clinical knowledge as to which predictors are likely to affect incontinence. We used the total number of surgeries to close the fistula (categorized into ≤2 and >2), number of days in labor (continuous variable), age at development of fistula (continuous variable), and number of deliveries before fistula (continuous variable) as confounders. Second, we used a multivariable logistic regression model to assess the association of “very severe” incontinence with social discrimination and used the current age and age at marriage as confounders. Third, we evaluated the association of “very severe” incontinence with physical abuse (kicked, slapped, or beaten), controlling for current age, age at marriage, and total number of surgeries. A P value of <.05 was considered to be significant.

Results

A total of 110 women were screened for this study, and 88 women were enrolled after meeting the inclusion criteria. Of these 88 women, 36 had persistent incontinence (cases) and 52 did not (controls). Cases were slightly older than controls at the time of this study (34.7±11.8 [range: 18–78; cases] vs 30.3±9.9 [range: 17–59; controls]; P =.06). Only 11% of cases and 12% controls had education above primary school. There was no significant difference between these two groups in the age at first marriage or at first childbirth, educational status, marital status, occupation, and source of income ( Table 1 ).

Cases tended to have acquired their fistula at a younger age than the controls (20.3±5.8 vs 24.8±7.5 years; P =.003). Most of the cases developed a fistula during their first delivery (63% vs 37%; P =.02), and they had more than two surgeries (67% vs 2%; P <.001) compared with the controls ( Table 2 ). They also reported a greater negative impact of their condition on their day-to-day life and on their physical and mental wellbeing. Both cases and controls reported high rates of suicidal ideation at any point since developing a fistula (36% vs 31%, P =.67). Cases reported a much higher rate of planned home births for their index pregnancy than the controls (44% vs 11%), yet ultimately, 75% of both groups delivered in the hospital; only 14% of cases and 12% of controls actually delivered at home. The rest delivered at health centers. The cases reported higher rates of pain with intercourse (36% vs 18%, P =.05), but recent sexual activity status (intercourse within the previous 6 months) was not significantly different between the groups (47% vs 62%, P =.18) ( Table 3 ). The cases also reported greater food insecurity than the controls (81% vs 46%; P =.002).

Table 2

Clinical history and circumstances surrounding childbirth (N=88)

Fistula history	Controls (n=52)	Cases (36)	P value
Developed fistula at their first birth, n (%)	19 (37)	22 (63)	.02 a
At least 1 delivery since fistula, n (%)	9 (17)	9 (25)	.38 a
Planned location of delivery, n (%)
Home	6 (11)	16 (44)	.002 a
Health Center	30 (58)	13 (36)
Hospital	16 (31)	7 (19)
Actual place of delivery, n (%)
Home	6 (12)	5 (14)	.91 a
Health Center	7 (13)	4 (11)
Hospital	39 (75)	27 (75)
Time with fistula before seeking treatment (y), n (%)
<1	32 (63)	12 (38)	.07 a
1–5	8 (16)	10 (31)
>5	11 (21)	10 (31)
Number of fistula surgeries, n (%)
1–2	50 (98)	12 (33)	<.001 a
>2	2 (2)	24 (67)
Number of deliveries before fistula
Mean±SD	2.5±2.5	1.2±2.0	.01 b
None, n (%)	19 (37)	22 (63)	.02 a
≥1	33 (63)	13 (37)
Number of deliveries since fistula, n (%)
None	43 (83)	27 (75)	.38 a
≥1	9 (17)	9 (25)
Days in labor at index delivery, (mean±SD)
	2.5±1.9	3.0±1.4	.21 b

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