Pelvic Floor Muscle Training on the Quality of Life in Women With Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Incontinence; Quality of Life
• Interventions: Other: Experimental; Other: Control

• Registration Number: NCT03514147
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

Aim: To assess the influence of pelvic floor muscles group training in the quality of life and functionality of these muscles in women with UI.

Study design: This is a randomized controlled trial.

Detailed Description

Search location: Urogynecology Ambulatory Care of Porto Alegre Clinical Hospital (HCPA)

Patients or participants: Women will be included in aged 35-70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, besides signing an informed consent form. Women will be excluded with latex allergy, who have made pelvic radiotherapy, or be undergoing chemotherapy, puerperal a year, or who use antidepressants and / or anxiolytics.

Intervention and measures: The evaluation consists of a medical history form, which will include personal data; the assessment of the MAP function is performed by the pressure biofeedback; for assessment of quality of life will use the questionnaire ICQI-SF and sexual function the PISQ-12 before and after Pelvic Floor Muscle Training.

Expected results: To estimate effectiveness of Pelvic Floor Muscle Training in the quality of life and functionality of these muscles in women with urinary incontinence.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-04
• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-05-01
• Last Update Submitted: 2018-05-01
• Study First Posted: 2018-05-02
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Female;
• Have urinary incontinence;
• Age between 35 and 70 years;
• Have 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

• Latex allergy;
• 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 MAP training in the last 6 months;
• Have contraction of the pelvic floor muscles grade zero (0).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Experimental	Pelvic Floor Muscle Training in group. Exercise Protocol: The exercise group was supervised and met for 1 hour, one time per week, for 12 weeks. Participants were instructed to perform their respective daily exercises.
Control	Control	Pelvic Floor Muscle Training in home Exercise Protocol:The same exercise were performed at home for 12 weeks, without supervision. Participants were instructed to perform their respective daily exercises.

Primary Outcome Measures

Name	Time	Method
Quality of life in women with urinary incontinence	12 weeks	International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.