Clinical trial NCT03500185: Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence
Official title: Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence: a Randomized Clinical Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Physiotherapy
Pelvic floor
Urinary Incontinence
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 56
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Be female;
* Have urinary incontinence;
* Between 30 and 70 years old;
* Have had sexual intercourse in the last 6 months;
* Participants should understand the instruments used in the research;
* Accept to participate in the study and sign the Term of Free and Informed Consent.

Exclusion Criteria:

* Have allergy to latex;
* Have performed or are undergoing pelvic radiotherapy;
* Be performing chemotherapy treatment;
* Women who delivered during the last 12 months;
* Have participated in individual or group PFMT in the last 6 months;
* Have contraction of the pelvic floor muscles grade zero (0).

Primary outcomes:
measure: Functionality of pelvic floor muscles
timeFrame: Evaluation after 24 weeks
Secondary outcomes:
measure: Sexual function
timeFrame: Evaluation after 24 weeks
measure: Quality of life in urinary incontinence
timeFrame: Evaluation after 24 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: JOSÉ GERALDO LOPES RAMOS
role: PRINCIPAL_INVESTIGATOR
References: