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

NCT03514147 | Completed

• 1 other identifier: 15-0271
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Incontinence; Quality of Life

Keywords

Women; Pelvic Floor Muscles

Outcome Measures

Primary Outcomes (1)

• Quality of life in women with urinary incontinence

  International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.

  12 weeks

Study Arms (2)

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.

Other: Experimental

Control

ACTIVE COMPARATOR

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.

Other: Control

Interventions

Experimental OTHER

1. Profile of participants: an anamnesis file was used to collect personal data; 2. To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention; 3. To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;

Also known as: Pelvic Floor Muscle Training in group

Experimental

Control OTHER

1. Profile of participants: an anamnesis file was used to collect personal data; 2. To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention; 3. To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;

Also known as: Pelvic Floor at Home

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Related Publications (1)

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• José Geraldo Lopes Ramos

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-04