Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The aim of the study is to compare the efficacy of a protocol, pelvic floor muscle training
      (PFMT), applied in a group and at home for urinary incontinence (UI) in women. Probably, the
      group-applied PFMT protocol is more effective in women with UI than the home protocol.
    

Detailed description: 
      Introduction: One of the female pelvic floor (PF) papers is to control urinary continence.

      Changes in your PF function and structure can cause the dysfunction of the PF. Among these UI
      is more commonly reported and affects one-third of adult women and generates significant
      impact on the quality and life of these, including sexual activity. Among the possibilities
      to treat UI in a conservative manner, the PFMT should be recommended as an intervention of
      first-line treatment for women with such symptoms. Such training can be developed
      individually or in a group, just to be prescribed and performed 6-12 weeks to demonstrate
      such effectiveness. Nevertheless they are still scarce in the literature studies involving
      the PFMT, group and individual in application, that have validated and well-defined protocols
      and, in addition, protocols that are easy to understand and play by the patients.

      Objective: The aim of the study is to compare the efficacy of a protocol of PFMT applied in a
      group and at home for UI in women.

      Methodology: The study presents an experimental design type randomized blind clinical trial.
      The sample is not probabilistic for convenience, which shall contain the minimum number of 28
      women in each group, obtained in the sample calculation. Women will be included from age 30
      to 70 years who have had sexual intercourse in the last 12 months and who are able to
      understand the instruments, and sign the consent form. Women will be excluded with latex
      allergy, who have made treatment of pelvic radiotherapy, or are undergoing chemotherapy,
      women who had childbirth in the last 12 months which have participated in PFMT individually
      or in groups in the past six months. The assessment consists of a medical history form, which
      will include personal data; the evaluation of the function of PF is performed by the muscles
      pressure biofeedback apparatus which measures pressure peak contraction of the pelvic floor
      via a cuff connected to the pressure transducer; to assess the impact of UI on quality of
      life will use the International Consultation on Incontinence Questionnaire (ICIQ-SF); for
      evaluation of sexual function is used Pelvic Organ Prolapse Quiz / Urinary Incontinence
      Sexual Questionnaire (PISQ-12). Statistical analysis will be performed using the Shapiro-Wilk
      test to verify the normality of the data. Descriptive analysis of parametric data will be
      expressed as mean and standard deviation, and the nonparametric median and interquartile
      range. The qualitative variables are expressed as absolute and relative frequency. In the
      inferential analysis will be used for comparison of continuous variables parametric
      intragroup, ANOVA and non-parametric variables the Wilcoxon test. In the analysis of
      categorical variables will be used the McNemar test. As for the inferential analysis will be
      used for comparison of continuous variables parametric intergroup, ANOVA and non-parametric
      variables the Mann-Whitney test. In the analysis of categorical variables will be used
      chi-square test. For all analyzes will be of significance level of 5% (p ≤ 0.05).
    

Intervention name(s): PFMT in group; PFMT at home
Intervention type(s): Other; Other
Intervention description(s): Participants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again.; Randomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiotherapy; Pelvic floor; Urinary Incontinence