Development and evaluation of a new pelvic floor muscle training Patient reported Outcome Measures (PROM) (PFMT-P).

OBJECTIVE: There are several Patient reported Outcome Measures (PROM) of knowledge, source of knowledge and practice of pelvic floor muscle training (PFMT), in different combinations but few integrating all three in one instrument. The objective of this study was the initial psychometric testing of a new PFMT PROM (PFMT-P), which aims to describe the knowledge, source of knowledge, and practices of PFMT for use by general female population, in order to contribute to preliminary validity and reliability. STUDY DESIGN: This study offered psychometric testing (validity and reliability) of a new assessment tool concerning PFMT (PFMT-P). The sample included 323 non-pregnant women, aged 20-50, who were heath care professionals and ancillary staff in one medical center in northern Israel. The PFMT-P was developed in Hebrew and composed of 3 sections: knowledge (score range 0-3), source of knowledge (initially scored), and practice (score range 3-35). A demographic and general health questionnaire was included. RESULTS: The face and content validity of the PFMT-P were evaluated by five experts with a factor analysis done on the practice component. Test-retest scores for internal consistency were reported for a group of 20 women, to whom the tool was administered 2 weeks apart. The results of the questionnaire components were knowledge, r= 0.538, p=0.014, and practice r=0.878, p<0.001. The component, source of knowledge on practice, showed non-significant results (p=0.796). Cronbach's alpha for the PFMT-P was 0.921 for the practice component. CONCLUSION: The PFMT-P was employed for the first time in a descriptive, correlational study, where its validity and reliability was tested and shows promise. The questionnaire is brief and easy to use. Continued research using this new PROM needs to be done to establish it as an assessment tool for PFMT programs.

Long-term efficacy of Paula method as compared with pelvic floor muscle training for stress urinary incontinence in women: a 6-month follow-up.

PURPOSE: The purpose of this study was to examine the long-term efficacy of an exercise regimen based on circular muscle strengthening (Paula method) as opposed to pelvic floor muscle training (PFMT) on stress urinary incontinence symptoms at 6 months postintervention. SUBJECTS AND SETTING: Of 240 women who had initially participated in a randomized clinical trial, 143 women suffering from stress urinary incontinence participated in this follow-up study. METHODS: Subjects participated in a randomized controlled clinical trial comparing 2 exercise programs (12 private Paula lessons vs 6 group PFMT lessons) over a 12-week period. Of these, 143 women took part in the follow-up study: 64 from the Paula group and 79 from the PFMT group. Six-month follow-up data were gathered via telephone interviews. RESULTS: No significant deterioration in stress urinary incontinence symptoms occurred 6 months after completion of the interventions in either group. We found a statistically significant difference between the groups with regard to reported frequency of urinary leakage; 25 of subjects (39.7%) allocated to the Paula method reported a low frequency rate of incontinence episodes upon completion of the study as compared to 18 (22.8%) in the PFMT group (P = .03). Forty-nine of the 64 women in the Paula group (76.6%) and 62 of the 79 women in the PFMT group (78.5%) reported that they continued exercising 6 months after completion of the trial (P = .8). CONCLUSIONS: Both intervention methods reduced frequency of urinary incontinence over a 6-month period. Long-term adherence was similar in both groups. Pelvic floor muscle training was associated with fewer sessions and decreased cost and fewer lessons needed as compared with the Paula method. Nevertheless, results also suggest that the Paula method achieves a lower frequency of urinary leakage than PFMT.

Concordance between one-hour pad test and subjective assessment of stress incontinence.

OBJECTIVES: To examine the concordance among the 1-hour pad test results, subjective questions regarding incontinence, and a quality-of-life questionnaire to assess the role of the pad test as a noninvasive measurement tool in clinical trials. The 1-hour nonstandard pad test is one of several quantitative tools used to measure urinary incontinence; however, its utility has been questioned. METHODS: The study subjects were women participating in 2 clinical trials evaluating noninvasive interventions: circular muscle exercises versus pelvic floor muscle training for urinary incontinence. The quantity of urinary leakage according to the pad test and questions regarding subjective urinary leakage from the quality-of-life questionnaire were evaluated for all study subjects combined and in subgroups. RESULTS: A total of 731 clinical pad tests were evaluated from the 2 trials. Significant associations were found between several questions regarding subjective leakage and the pad test results in the study subgroups. A significant correlation was seen between the pad test results and the quality-of-life questionnaire scores (r = 0.14 before intervention and r = 0.42 after intervention in the combined studies; P < .05). CONCLUSIONS: The 1-hour pad test demonstrated concordance with subjective assessment tools for urinary incontinence and should be considered a part of the armamentarium for assessing the severity of this condition.

Randomized trial of circular muscle versus pelvic floor training for stress urinary incontinence in women.

BACKGROUND: Conservative management, such as pelvic floor muscle training (PMFT), is commonly recommended as first-line therapy for women with stress urinary incontinence (SUI). METHODS: We randomly assigned 245 women with SUI to 12 weeks of circular muscle exercises (Paula method) or PMFT in order to assess whether these approaches are equivalent. End points after 12 weeks included urinary leak as measured by a 1-hour pad test, subjective assessment of incontinence, and quality of life (QOL). Cure was defined as urinary leakage of <1 g. RESULTS: The mean decrease in urinary leakage was 7.9 g (SD 12.1) among women in the Paula group and 8.9 g (SD 18.2) in the PFMT group (90% confidence interval [CI] of between-group difference was -4.68 g to 3.0 g). This did not meet the prespecified criterion for equivalence. There were 15.2% (p = 0.04) more cures in those randomized to the Paula method. Improvement in subjective urinary complaints and QOL was observed in both groups. The study was limited by a dropout rate of 26.6%. CONCLUSIONS: Both methods are efficacious in women with SUI. The results suggest superiority of the Paula method in terms of cure rate.

Paula method of circular muscle exercises for urinary stress incontinence--a clinical trial.

The aim of this study was to determine the efficacy of the Paula method of circular muscle training in the management of stress incontinence (SI). The theory behind this method states that activity of distant sphincters affects other muscles. In a pilot study, 59 women, mainly hospital employees, were randomly assigned to participate in exercises according to the Paula method or pelvic floor training. Efficacy was measured by reports of incontinence, quality of life (I-QOL), pad test, and pelvic floor muscle strength (assessed by perineometer and digital examination). Both the Paula exercises and pelvic floor training produced significant changes in urinary leakage compared to baseline as measured by the pad test [mean decrease of 5.4 g (p=0.002) and 9.5 g (p=0.003), respectively]. Women randomized to the Paula method reported improvement in I-QOL scores. The Paula method was found to be efficacious for SI in a population of Israeli women. Larger community-based studies will be required to confirm these results and enable evaluation of between-group differences.