Study setting and study population
We conducted this prospective cohort study at the Urogynecology unit of Mbarara Regional Referral Hospital (MRRH) from December 1, 2018 to December 31, 2020, among women diagnosed with symptomatic pelvic organ prolapse (POP) destined for surgery. MRRH is a tertiary Hospital located in Mbarara district in Southwestern Uganda about 250 kilometers from the capital city of Kampala. MRRH is the main referral hospital of the entire southwestern Uganda serving over 10 districts and also gets patients from the neighboring countries of Tanzania, Rwanda, Burundi and the Eastern Democratic Republic of Congo (DRC).
Data collection and study variables
We conducted a cohort study among women diagnosed with symptomatic POP and were scheduled for surgery at the Urogynecology unit of Mbarara Regional Referral Hospital (MRRH) between December 1, 2018 and December 31, 2020. The diagnosis, staging and decision to do surgery was made by the urogynecology surgical team. Participants were considered to have POP if they had any one of the following clinical diagnoses: cystocele, urethrocele, cystourethrocele, uterine prolapse, vault prolapse, enterocele or rectocele. Categorization and staging of POP was done using the Pelvic Organ Prolapse Quantification (POP-Q) system of 2011 into stages I, II, III and IV (29). The participants had their quality of life (QOL) determined at enrolment prior to surgery. The QOL before surgery was determined using the King’s Health Questionnaire (30). This questionnaire was validated to assess the QOL among women with urinary incontinence but we used it to assess QOL among women with POP in our study as a number of women with POP have been shown to have urinary incontinence (31-33). This interviewer-based questionnaire assesses 7 QOL domains that include physical/ daily roles performance, social interraction, sexual function, emotional/ psychological state, personal hygiene, sleep quality and bladder function. A score (%) for each of the domains was calculated. Each life domain had a score ranging from 0 to 100%. The overall QOL for each participant was obtained as an average of the total scores in the 7 domains. The higher the scores the poorer the QOL. The participants underwent surgery for the management of POP and were followed up for a period of 12 months. Participants were contacted by a phone call one week prior to their scheduled visit. The participants who could not be reached on phone were traced using the contact of their next of kin. This was to minimize loss to follow-up. Surgery was done for those who had symptomatic POP stage II, III and IV and was dependent on the type of prolapse. The different types of surgeries that were performed included anterior colporrhapy for cystocele, posterior colporrhapy for rectocele, vaginal hysterectomy with vaginal vault suspension (sacrospinous ligament or uterosacral vault suspension) for uterine prolapse in those who had completed child bearing and did not want uterine sparing surgery. Cervicopexy was done for those with uterine prolapse that hadn’t completed child bearing or wanted uterine sparing surgery. The QOL at 1 year post-surgery was determined using the King’s Health Questionnaire (30).
Trained research assistants who included counsellors and nurses who were not part of the surgical team conducted the interviews and completed the King’s Heath Questionnaire. An interviewer guided data capture tool was administered to collect information on the baseline characteristics of the study participants. These included: age, parity, education level, marital status, occupation, smoking, alcohol use, type and severity of the prolapse. Age in years was categorized according to reproductive age groups: 18-34 (early reproductive age group), 35-49 (late reproductive), 50-59 (peri-menopausal) and ≥60 (post-menopausal).
We assumed a sample size of 120, mean QOL score before surgery of 44.5 with a standard deviation of 20.9 and a mean QOL score after surgery of 8.0 with a standard deviation of 11.6. We therefore obtained a power of 100% to detect a difference in means.
Data were entered into Redcap and exported to Stata 13 (StataCorp, LLP, College Station, TX, USA) for analysis. Categorical data were presented as frequencies (%). The mean QOL score and the 95% confidence intervals for each of the seven domains and the overall mean QOL at baseline and at 1 year after surgery were calculated. The overall mean QOL score before and at 1 year after surgery was compared as well as the mean scores in each of the domains. A paired t-test was used to determine if there was a significant difference in the means. A p value of < 0.05 was considered significant.
Ethical approvals were obtained from the Mbarara University of Science and Technology (MUST) Research Ethics Committee and the Uganda National Council for Science and Technology (UNCST) number HS368ES. We informed the participants of the study objectives and only those that gave written consent were recruited. Confidentiality was observed during all the interviews. Personal identifiers such as name and in-patient number were not collected. The study participants were assigned study ID numbers.