Strengthening validity in studies of pelvic floor disorders through qualitative research: an example from Ethiopia.

INTRODUCTION AND HYPOTHESIS: This formative qualitative follow-up study addresses validity concerns in the Dabat Incontinence and Prolapse (DABINCOP) study, which aimed to determine the prevalence of pelvic floor disorders in north-west Ethiopia. A pilot study using a questionnaire validated by pelvic exam showed severe underreporting of clinically relevant pelvic organ prolapse (POP). The objective of the follow-up study was to explore the reasons behind the underreporting and to gather information to strengthen the sensitivity and local relevance of the questionnaire to be employed in the main study. METHODS: A qualitative formative study nested within the DABINCOP study was carried out in rural and semiurban communities using an interpretive approach and in-depth qualitative interviews. Women (5) who had not self-reported POP in the pilot but were diagnosed with severe prolapse after pelvic examination, and health-care workers in the research team (7) were interviewed individually within 1 year of the pilot. Systematic text condensation was used in the analysis. RESULTS: The women explained that shame and fear of social exclusion, lack of trust in the study and data collectors, and lack of hope for cure prevented them from disclosing. The health-care workers reported weaknesses in the questionnaire and the research approach. Time pressure and competition among data collectors may have compromised women's motivation to disclose. CONCLUSIONS: The study indicates that qualitative research may fruitfully be employed in the formative phase of an epidemiological study on sensitive reproductive health problems to enhance local relevance of the tool and overall validity of the study.

Living with pelvic organ prolapse: voices of women from Amhara region, Ethiopia.

INTRODUCTION: The objective of the study was to explore how women with symptomatic pelvic organ prolapse in a low-income setting explain, experience, and handle the potential practical and social consequences of the condition. METHODS: An explorative qualitative design was employed using in-depth interviews in the data collection. A total of 24 women with different degrees of symptomatic pelvic organ prolapse were included; 18 were recruited at the hospital and 6 from the community. Fieldwork was carried out in the Amhara region of northwest Ethiopia in 2011 and 2015. RESULTS: The informants held that the pelvic organ prolapse was caused by physical strain on their body, such as childbirth, food scarcity or hard physical work, particularly during pregnancy and shortly after delivery. Severe difficulties and pain while carrying out daily chores were common among the women. The informants used a variety of strategies to manage their work while striving to avoid disclosure of their condition. Disclosure was related to embarrassment and fear of discrimination from people living close to them, including the fear of being expelled from the household. Most of the informants, however, experienced substantial support from relatives, friends, and at times also from their husband, after disclosing their condition. CONCLUSIONS: The study highlights how symptomatic pelvic organ prolapse may severely affect women's lives in a low-income setting. The condition is perceived to be both caused by and aggravated by the heavy physical burdens of daily work.

Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial.

BACKGROUND: Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula. METHODS: In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fistula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fistula. A research assistant at each site randomly allocated participants 1:1 (randomly varying block sizes of 4-6; stratified by country) to 7 day or 14 day bladder catheterisation (via a random allocation sequence computer generated centrally by WHO). Outcome assessors were not masked to treatment assignment. The primary outcome was fistula repair breakdown, on the basis of dye test results, any time between 8 days after catheter removal and 3 months after surgery. The non-inferiority margin was 10%, assessed in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT01428830. FINDINGS: We randomly allocated 524 participants between March 7, 2012, and May 6, 2013; 261 in the 7 day group and 263 in the 14 day group. In the per-protocol analysis, ten (4%) of 250 patients had repair breakdown in the 7 day group (95% CI 2-8) compared with eight (3%) of 251 (2-6) in the 14 day group (risk difference 0·8% [95% CI -2·8 to 4·5]), meeting the criteria for non-inferiority. INTERPRETATION: 7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown, urinary retention, or residual incontinence up to 3 months after surgery. FUNDING: US Agency for International Development.

Musculoskeletal sequelae in patients with obstetric fistula - a case-control study.

BACKGROUND: Obstetric fistula is essentially a result of pelvic injury caused by prolonged obstructed labour. Foot drop and walking difficulties in some of these women signify that the injury may extend beyond the loss of tissue that led to the fistula. However, these aspects of the pelvic injury are scarcely addressed in the literature. Here we specifically aimed at assessing musculoskeletal function in women with obstetric fistula to appreciate the extent of the sequelae of their pelvic injury. METHODS: This case-control study compared 70 patients with obstetric fistula with 100 controls matched for age and years since delivery. The following was recorded: height, weight, past and present walking difficulties, pain, muscle strength and joint range of motion, circumference and reflexes. Differences between groups were analysed using independent sample t-test and chi-square test for independence. RESULTS: A history of leg pain was more common among cases compared to controls, 20% versus 7% (p = 0.02), and 29% of the cases had difficulties walking following the injuring delivery compared to none of the controls (p ≤ 0.001). Of these, four women reported spontaneous recovery. Cases had 7° less range of motion in ankle dorsal flexion (95%CI: -8.1, -4.8), 8° less ankle plantar flexion (95%CI: -10.6, -6.5), 12° less knee flexion (95%CI: -14.1, -8.9), and 4° less knee extension (95%CI: 2.9, 5.0) compared to controls. Twelve % of the cases had lower ankle dorsal flexion strength (p = 0.009). Foot drop was present in three (4.3%) compared with none among controls. Women with fistula had 4° greater movement in hip extension (95%CI: -5.9, -3.1), 2° greater hip lateral rotation (95%CI: 0.7, 3.3) and 9° greater hip abduction (95%CI: 6.4, 10.7). Twelve % of the cases had stronger medial rotation in the hip (p = 0.04), 20% had stronger hip lateral rotation (p ≤ 0.001), 29% had stronger hip extension (p ≤ 0.001), and 15% had stronger hip abduction (p = 0.04) than controls. CONCLUSIONS: Women with obstetric fistula commonly experienced walking difficulties after the delivery, had often leg pain and reduced function in the ankle and knee joints that may have been compensated by increased motion and strength in the hip.

Silently waiting to heal: experiences among women living with urinary incontinence in northwest Ethiopia.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to gain in-depth knowledge of women suffering from urinary incontinence (UI) in rural and semiurban settings in Ethiopia. METHODS: A qualitative study based on semistructured in-depth interviews with 26 informants, 18 of whom were women experiencing the symptom of urinary leakage. The study was conducted in the Amhara Region of northwest Ethiopia and was part of the Dabat Incontinence and Prolapse (DABINCOP) study. RESULTS: Limited access to water, soap, pads, and spare clothes characterized daily management of the symptom. The consequences for marital relationships and social life were of great concern to the informants. Shame, embarrassment, and fear of being discriminated against led to huge efforts to hide the leakage. Among informants who were not able to hide it, humiliating comments and discriminatory behavior were commonly experienced, sometimes leading to divorce and self-isolation. Women who disclosed their symptom usually had a person who supported them. Women with UI regarded it as unnatural and uncommon. Most took no action to improve the situation, as they saw no options for help. CONCLUSIONS: Several circumstances limited the opportunities available to women to keep themselves clean, disclose the problem to others, and access health information and health-care facilities. In order to understand how women in this setting practically handled, perceived, and experienced living with UI, it was essential to address contextualized and sociocultural dimensions related to the symptom.

Pelvic floor disorders among women in Dabat district, northwest Ethiopia: a pilot study.

INTRODUCTION AND HYPOTHESIS: Pelvic floor disorders affect many women in high-income countries. Since little is known about such disorders in Africa, this study aimed at assessing the prevalence and risk factors in an Ethiopian community. We also assessed the validity of a prolapse questionnaire. METHODS: A community-based cross-sectional study was conducted among 395 women, recruited by a systematic random sampling technique. Women were interviewed about symptoms of urinary incontinence, faecal incontinence and pelvic organ prolapse by female nurses. Additionally, pelvic examinations were performed in 294 (74.2%) participants to assess anatomical prolapse using the simplified Pelvic Organ Prolapse Quantification staging system. Descriptive statistics and logistic regression analyses were employed. RESULTS: The median age of participants was 35.0 years. Thirty-one women reported urinary incontinence (7.8%), 25 (6.3%) symptomatic pelvic organ prolapse and 2 (0.5%) faecal incontinence. Anatomical pelvic organ prolapse stage II-IV was detected in 162 (55.1%) of women who underwent pelvic examination. The questionnaire for prolapse assessment had poor validity (38.3% sensitivity and 95.4% specificity) even in cases of clinically relevant prolapse (stage III or IV). After adjustment, carrying heavy objects for 5 or more hours a day, history of prolonged labour and highland rural residence were associated with anatomical pelvic organ prolapse. CONCLUSIONS: Self-reported incontinence seems low in northwest Ethiopia. The prevalence of symptomatic prolapse was low despite a high prevalence of prolapse signs. Notably, heavy carrying and prolonged labour increased the risk of anatomical prolapse stage II-IV. The methods of assessing pelvic floor disorders in a low-income context need further development.

Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial.

BACKGROUND: A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. METHODS/DESIGN: This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site. DISCUSSION: If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01428830.

Development and Pilot Test of a Group Cognitive Behavioral Intervention for Women Recovering From Fistula Repair Surgery in Ethiopia.

Obstetric fistula is a serious complication that affects thousands of women in low-income countries. Women who suffer from obstetric fistulae are at risk of developing mental health problems, but to date most interventions have focused on repairing the physical consequences of fistulae through surgery. The goal of the current study is to develop an evidence-based intervention targeting symptoms of depression, anxiety, and trauma in women recovering from fistula repair surgery. First, hospital staff and patients awaiting surgery at a fistula hospital in Ethiopia participated in qualitative interviews to provide information on the mental health needs of women with fistulae, how the hospital tends to these women's psychological needs, and the training needs of staff members. Data from these interviews were used to develop the COFFEE intervention (CBT with Obstetric Fistula for Education and Empowerment). COFFEE is a modular, group intervention that teaches psycho-education, behavioral activation, relaxation, problem solving, cognitive restructuring, and includes a trauma narrative. Patients then participated in an open trial of the COFFEE intervention at the University of Gondar Hospital. Five separate groups were conducted with 24 women who were enrolled post-fistula repair surgery. Women completed pre-treatment self-report questionnaires, participated in group sessions conducted by nurses (with 8 sessions delivered across 10-14 days), and were assessed post-treatment and at 3-month follow-up. Results indicate a significant reduction on depression and anxiety symptoms scores across the three time points [F(2, 40) = 68.45, p < 0.001 partial η2 = 0.774]. Additionally, there was a significant decrease in traumatic stress scores from baseline to post-treatment [F(1.10, 21.98) = 100.51, p < 0.001 partial η2 = 0.834]. Feedback forms completed by nurses and patients suggest the intervention was well-received. Results of this open-trial suggest the COFFEE intervention is feasible, acceptable, and clinically beneficial to treat symptoms of depression, anxiety, and traumatic stress in women post-fistula repair surgery in a hospital setting.

Obstetric fistula in 14,928 Ethiopian women.

OBJECTIVES: Obstetric fistulas are severe sequelae of prolonged obstructed labor, a widespread but incompletely documented problem of low-income countries. Here, we characterize women with obstetric fistula, test the hypothesis that primi- and multipara represent different profiles and that fetal size is an important factor in developing fistula. DESIGN: Hospital registry statistics and questionnaire. POPULATION: A total of 14,928 Ethiopian women with obstetric fistula in 1974-2006 and 434 admitted in 2007-8. METHODS: Self-reported age, marital status, education, distance from home to health facility, parity, duration of labor, neonatal outcome and sex, lag time to treatment; measurement of weight, stature, extent of lesion and clinical assessment of continence before hospital discharge. OUTCOME MEASURES: Duration of labor, extent of pelvic injury and neonatal survival, cure rate. RESULTS: Primi- were more common than multiparous cases (56.8 vs. 43.2%). They were of similar age at marriage (17 years) and stature at hospital admission, but shorter than the population average (152.7 vs. 156.5 cm). Primipara had longer labor than multipara (50.5% > 3 days vs. 27%), larger uro-vaginal fistula, more stillbirths (95 vs. 88%), recto-vaginal fistula, vaginal scarring, persistent incontinence after repair and were more commonly divorced. Male fetuses were involved in 76.7% of obstructed deliveries but in only 44.6% of a previous uneventful delivery in multipara. Educational attainment positively influenced outcomes. CONCLUSIONS: Obstetric fistula is more commonly associated with primiparous than subsequent pregnancies. Primipara have a longer and more damaging labor. A causative role for cephalo-pelvic disproportion is supported by the observation that male fetuses are more commonly involved in obstructed labor.

Antibiotic use in obstetric fistula repair: single blinded randomized clinical trial.

INTRODUCTION: The beneficial effect of extended use over single dose of antibiotics in obstetric fistula repair is unknown, however, is practiced widely. METHODS: From September 2006 to February 2008, a total of 722 eligible women with obstetric fistula were randomly assigned to receive either of 80 mg Gentamycin IV (immediately after spinal anesthesia), or extended use of Amoxicillin, Chloramphenicol or Cotrimexazole (postoperatively) and followed post operatively. Post surgery progresses, interventions andfinal results were recorded on the standard format prepared. RESULTS: A total of 722 study participants were followed, the mean age was 25.1 years (24.6, 25.6), 90.4% were illiterate, 33.2% were divorced and 53.2% were injured during their first delivery. About 81% of women had bladder injury without rectal and anal sphincter involvement, and over 70% had prolonged labor (labour lasted over 24 hours). Proportion of women with the above mentioned parameters was similar among the two groups. Additional procedures (Martius fat graft and minilaparatomy); the amount of blood loss; and the length ureteric catheters and vaginal pack stayed were not different among the two groups. The proportion of women with successfild fistula closure was similar among the two groups; 94.5% (92.1, 96.9) for single dose of Gentamycin vs. 89.4% (86.2, 92.6) for extended dose of other antibiotics. Hospital stay; proportion of women with fever, post repair infection; post operation stress incontinence and other residual incontinences were not different among the two groups. CONCLUSIONS: Single dose of Gentamycin (80 mg IV) given preoperatively at the administration of spinal anesthesia appears to be equally effective as the extended use of either of or combination of Amoxicillin, Chloramphenicol and Cotrimexazole.

Health and social problems encountered by treated and untreated obstetric fistula patients in rural Ethiopia.

OBJECTIVE: To assess health, social, and psychological problems encountered by women with treated and untreated obstetric fistula (OF). METHODS: A cross-sectional study consisting of quantitative and qualitative components was conducted in seven administrative regions of rural Ethiopia. Fifty-two women with OF were interviewed on the subjects of their socioeconomic status and history of the development of OF. Qualitative in-depth interviews were conducted with 27 of the untreated women and seven of the treated women. RESULTS: A total of 19 153 houses were surveyed, and 55 women with fistulae were identified, of whom 52 were interviewed. Thirty-six of the interviewed women (69.2%) were divorced, 10 (19.2%) were not allowed to eat with family members, and 23 (44.2%) were not members of any community associations. Of the 48 women with feelings of depression, 28 (54.2%) had suicidal ideation. Twenty-four women attributed their development of a fistula to evil spirits, to a curse, or to sin. The in-depth interviews revealed that treatment improved family and social life; however, some health, social, and sexual problems remained. CONCLUSION: Women with OF encounter health, psychological, and social consequences that are not completely resolved by repairing the fistula. The care of women with OF should go beyond surgical treatment and should include support for their reintegration into the community with proper follow-up.

Obstetric fistula in developing countries: a review article.

Obstetric fistula, one of the most devastating consequences of prolonged obstructed labour, is a historical issue in the developed world. However, it is still prevalent in resource poor countries like Ethiopia. The objective of this review article is to describe the epidemiology of obstetric fistula and its management, with specific emphasis on the experience of the Addis Ababa Fistula Hospital. Published and unpublished literature on obstetric fistula was reviewed, and expert opinions are used in augmentation. Most obstetric fistulas result from neglected obstructed labour, often affecting very poor, young, illiterate, rural women and girls. The women are often in labour for days, helped by unskilled family members. They deliver a stillborn child, become incontinent of urine and/or feces, and become outcast and divorced as a result. Surgical repair mends the lives of thousands of women, although not all injured cases have access to treatment. Although prevention should be the ultimate goal, the need for curative care services for the sufferers is shown to be significant.

Socio-demographic profile and obstetric experience of fistula patients managed at the Addis Ababa Fistula Hospital.

Obstetric experience, clinical and socio-economic characteristics, and reasons for preference of place of delivery of 639 fistula patients admitted to the Addis Ababa Fistula Hospital between May 1999 and February 2000 are described About 94% of fistula patients were married and 83.6% had been through with the delivery caused the fistula before the age of 20. The mean ages at the first marriage and at the causative delivery were 14.7 (sd=2.6) and 17.8 (sd=3.2) years respectively. Mean height of fistula patients studied was 149 cms (sd=8). About 64% were primiparous, 44% (279) delivered at home, and labor lasted for 3.8 days on average. Majority of fistula patients mentioned distance as a main problem for the delays. Lack of money, poor knowledge and delay in referral were the other frequently mentioned reasons for the delays. About 62%(399) of fistula patients owned nothing valuable. Of 279 patients delivered at home 186 were those who owned nothing. Out of 180-fistula patients mentioned distance as the major problem, 103 (57%) stayed at home for delivery. About 54% of fistula patients were already divorced on arrival to the hospital and this figure varied among women with different parity and among those owning different property. Teenage and short stature are observed features of fistula patients. The study also showed the huge problems faced by fistula patients in accessing emergency obstetric care services. Analytic study is recommended to compare the magnitude of these problems among other mothers with different obstetric outcome. Meanwhile, community education about problems following teenage pregnancy, sign and symptoms of obstructed labor and the advantage of institutional delivery might reduce the occurrence rate of obstetric fistula. Community organized fund and maternity waiting areas for young and short expecting mothers are among other recommendations to be considered.

Septic shock.

Septic shock remains an important cause of death and serious morbidity in medical, surgical and obstetric illness. Many patients with septic shock succumb despite aggressive therapy. Any microorganism can initiate septic shock; the pathophysiology of the disease is not clear; the clinical manifestation is not specific; and there is no reliable laboratory result to diagnose septic shock before it is late. Moreover, despite increasingly complex modes of mechanical ventilation, sophisticated respiratory and hemodynamic monitoring, and a continually expanding array of potent antibiotics, the overall mortality from septic shock remained constant. Better outcome is more likely when recognition is early and treatment is much more aggressive. Therefore, where there is suspicion of septic shock: commence fluid resuscitation, administer oxygen, take blood, urine, and other fluids for culture, commence intravenous broad-spectrum antibiotics, pass a urethral catheter, determine the cause of sepsis and remove if possible, consult for expert medical advice and possible patient transfer to intensive care units, and provide supportive care to involved organ systems.