Abstract
BackgroundPost-fistula-repair incontinence (PFRI) is a common complication of vesicovaginal fistula (VVF) surgeries. It entails continuous leakage of urine after successful VVF closure. Pelvic Floor Muscle Training (PFMT) plays a vital role in the management of PFRI, however, an evolving exercise approach is the Paula Exercise Method (PEM) which has shown a promising effect in stopping urinary incontinence, but there is no data on its effect on PFRI. This study therefore, proposes to primarily investigate the effect of PEM on urine leakage and secondarily, pelvic floor strength (PFS), quality of life (QoL), sexual function (SF), and mental health (MH) in women with PFRI.MethodsThis is a study protocol for a randomized controlled trial. A total of 182 participants are expected to participate in the study after satisfying the inclusion criteria. The participants will be randomized into either PEM or PFMT study groups. The demographic data of all the participants will be recorded. Each participant will be assessed for urine leakage, PFS, QoL, SF, and MH at baseline and subsequently, at four, eight and 12 weeks of intervention.Demographic parameters will be summarized using descriptive statistics. Continuous data will be computed for differences using inferential statistic of Analysis of variance, t-test and Man Whitney U as appropriate. All analyses will be performed using SPSS version 22.0 with probability set at 0.05 alpha level.DiscussionIt is hoped that the outcome of this study will determine the effect of the Paula exercise method on urine leakage, pelvic floor strength, quality of life, sexual function, and mental health among women with post-fistula-repair incontinence and also provide evidence for the use of the Paula method in urinary incontinence.Trial registration: Pan African Clinical Trials Registry (www.pactr.org), identifier PACTR201906515532827.
Highlights
Post-fistula-repair incontinence (PFRI) is a common complication of vesicovaginal fistula (VVF) surgeries
It is hoped that the outcome of this study will determine the effect of the Paula exercise method on urine leakage, pelvic floor strength, quality of life, sexual function, and mental health among women with post-fistularepair incontinence and provide evidence for the use of the Paula method in urinary incontinence
This study aims to contribute to filling this gap and is targeted at investigating the effectiveness of the Paula exercise method in women with PFRI
Summary
Post-fistula-repair incontinence (PFRI) is a common complication of vesicovaginal fistula (VVF) surgeries. It entails continuous leakage of urine after successful VVF closure. This study proposes to primarily investigate the effect of PEM on urine leakage and secondarily, pelvic floor strength (PFS), quality of life (QoL), sexual function (SF), and mental health (MH) in women with PFRI. The consequences of VVF can be devastating, as it affects women physically, socially, economically and psychologically [3, 4]. In Nigeria, according to the Federal Ministry of Health [9], there are over 20,000 new cases of VVF yearly, in addition to the approximately 400,000–800,000 existing cases awaiting surgical repair. Over 85% of all cases of VVF are found in the north-western part of Nigeria [7, 10]; high incidences are reported in Kano, Katsina and Bauchi states in this region of the country [7]
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