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. 2021 Mar 9;21(1):101.
doi: 10.1186/s12905-021-01249-w.

Effect of Paula exercise method on functional outcomes of women with post fistula repair incontinence: a protocol for randomized controlled trial

Saratu Umar Aliyu  1   2 , Shmaila M Hanif  3 , Isa Usman Lawal  4
Affiliations

Effect of Paula exercise method on functional outcomes of women with post fistula repair incontinence: a protocol for randomized controlled trial

Saratu Umar Aliyu et al. BMC Womens Health. .

Abstract

Background: Post-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.

Methods: This 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.

Discussion: 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-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.

Keywords: Paula exercise method; Pelvic floor muscle training; Post repair incontinence; Urinary incontinence; Vesicovaginal fistula.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Study flow diagram
See this image and copyright information in PMC

References

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