Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

NCT ID: NCT03058042

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2017-12-30

Brief Summary

The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. The hypothesis of this study is that home pelvic floor muscle training is as effective as outpatient pelvic floor muscle training for the treatment of stress urinary incontinence.

Detailed Description

Success with the pelvic floor muscle training (PFMT) is hampered by non-adherence, which is related to factors such as inability to contract the pelvic floor muscles and lack of motivation. Thus under supervision by a physiotherapist (outpatient training), PFMT has the potential of improving adherence to training and has been demonstrated to be more effective when compared to unsupervised PFMT (home training). The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. This is a randomized controlled trial and which will be conducted at the Division of Urogynecology and Reconstructive Pelvic Surgery at the Federal University of Sao Paulo, Brazil. As a primary endpoint, the standardized volume test pad (250 mL) will be used. To assert that one of the groups (home PFMT or outpatient PFMT) is superior to the other, it will be necessary to find 38.5% more patients cured when the groups are compared. Secondary outcome measures will be used, assessment of the pelvic floor muscles function, urinary symptoms, quality of life and subjective cure.

Conditions

Urinary Incontinence, Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home pelvic floor muscle training

Patients will perform strength training of the pelvic floor muscles daily at home. The training protocol consists of three sets of 30 slow contractions (type I muscle fibers), with maintenance contraction according to the initial evaluation, followed by three rapid contractions (type II muscle fibers) after each slow contraction. The protocol will account for 90 contractions of the pelvic floor muscles per day. At the end of one month, the patients will return for consultation, in which the MAP evaluation and training progression will be performed.

Group Type: EXPERIMENTAL

Exercises of the pelvic floor muscle at home

Intervention Type: OTHER

Patients will perform pelvic floor exercises at home.

Outpatient pelvic floor muscle training

The patients will perform 24 outpatient sessions of pelvic floor muscle strength training and home training. The training protocol consists of three sets of 30 slow contractions (type I muscle fibers), with maintenance contraction according to the initial evaluation, followed by three rapid contractions (type II muscle fibers) after each slow contraction. The protocol will account for 90 contractions of the pelvic floor muscles per day. At the end of one month, the patients will perform the evaluation of the MAP and progression of the training.

Group Type: SHAM_COMPARATOR

Exercises of the pelvic floor muscle in the outpatient

Intervention Type: OTHER

Patients will perform pelvic floor exercises in the outpatient.

Interventions

Exercises of the pelvic floor muscle at home

Patients will perform pelvic floor exercises at home.

Intervention Type: OTHER

Exercises of the pelvic floor muscle in the outpatient

Patients will perform pelvic floor exercises in the outpatient.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test

Exclusion Criteria

younger than 18 years old chronic degenerative diseases pelvic organ prolapse greater than stage I by POP-Q neurologic or psychiatric diseases inability to contract PFMs previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fatima Fitz

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo A Castro

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo

Locations

Fátima Faní Fitz

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39704322 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id