Paula Method (Circular Muscle Exercise) for Urinary Incontinence Symptoms of Women with Multiple Sclerosis: A Pilot Study

Methods

A pilot clinical trial with pre–postdesign included a cohort of women diagnosed with MS currently suffering from UI. Main inclusion criteria were 18 years and older, complained of UI 4 weeks before recruitment, and diagnosed with an Expanded Disability Status Scale (EDSS) ⁵ of ≤7.5. Exclusion criteria were pregnant women, those within 12 weeks of delivery; 6 weeks postabortion; symptomatic signs of urinary tract infection; problem of genital prolapse; and those who had a permanent catheter for urination. Main tools used were the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-SF) ⁶ and the Questionnaire for Urinary Incontinence Diagnosis. ⁷ Other tools were validated questionnaires for QOL, sexual function, EDSS, and a demographic health questionnaire. This study was approved by the institutional review board, and a signed informed consent was obtained (ClinicalTrials.gov Identification code: NCT01871337). Throughout the training course, subjects received a weekly 45-min group training session for 12 weeks. Sample size calculation included 34 women. The distributions for continuous variables were described by means and standard deviations (M ± SD) or by median and interquartile range whenever the Wilcoxon test was performed. Changes between pre- and postintervention were assessed by paired Wilcoxon for related samples. Statistical tests included a two-sided p-value <0.05 that was considered significant.

Results

Twelve participants enrolled in this study, and one dropped out after three sessions due to personal reasons. The median age was 56 years old (ranged 47–75). Ten of the 12 women (83.3%) were diagnosed with MS for >10 years. All of the participants had completed secondary school, and most of them were unemployed during the study period. Seven (58.4%) of the women urinated more than seven times a day, and nine (75%) of the women used absorbing pads.

Ten women completed the ICIQ-SF before and after the intervention, and a significant reduction in UI was noted (from 5 before the intervention and decreased to a score of 1 postintervention; z = −2.395 p = 0.017). The median ICIQ-SF score was 13 before the intervention and 9.5 after the intervention (the significant difference between the pre- and postintervention yielded a moderate Cohen-d effect size of 0.43). There were no significant differences between pre- and postintervention regarding the other questionnaires (Table 1).

Discussion

The Paula method is an effective treatment procedure for women with MS who suffer from UI and other correlating LUTDs.

The main limitations of this pilot study pertained to recruitment failures. People with MS demonstrate a lower level of physical activity than healthy people ⁸ and find physical activity to be too taxing, ⁹ which contributed to refraining from a study located far from home.

In conclusion, the innovation of this study is grounded in the implementation and efficacy displayed by incorporating the Paula methods as a treatment tool for patients with MS who experience UI.