Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence

NCT03500185 | Completed

• 1 other identifier: 15-0316
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Physiotherapy; Pelvic floor; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Functionality of pelvic floor muscles

  Capacity of voluntary contraction that reduces light and vaginal length, generating intravaginal pressure, in the case of this study evaluated by PERFECT Scale.

  Evaluation after 24 weeks

Secondary Outcomes (2)

• Sexual function

  Evaluation after 24 weeks

• Quality of life in urinary incontinence

  Evaluation after 24 weeks

Study Arms (2)

PFMT in group

EXPERIMENTAL

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.

Other: PFMT in group

PFMT at home

ACTIVE COMPARATOR

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.

Other: PFMT at home

Interventions

PFMT in group OTHER

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.

PFMT in group

PFMT at home OTHER

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.

PFMT at home

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

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

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: April 18, 2018
• Study Start: April 17, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

BR (1)