Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

NCT03058042 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Stress

Keywords

Urinary Incontinence, Stress; Pelvic Floor; Exercise; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• Change in pad test

  To quantify the severity of SUI and as the tool to estimate objective cure rate

  Baseline, after 3 months of treatment

Secondary Outcomes (4)

• Change in 7-Day Voiding Diary

  Baseline and after 3 months of treatment

• Change in pelvic floor muscle function (Oxford Grading Scale)

  Baseline and after 3 months of treatment

• Change in Incontinence Quality-of-Life Questionnaire (I-QoL)

  Baseline and after 3 months of treatment

• Subjective cure of SUI ("satisfied" or "dissatisfied")

  Baseline and after 3 months of treatment

Study Arms (2)

Home pelvic floor muscle training

EXPERIMENTAL

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.

Other: Exercises of the pelvic floor muscle at home

Outpatient pelvic floor muscle training

SHAM COMPARATOR

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.

Other: Exercises of the pelvic floor muscle in the outpatient

Interventions

Exercises of the pelvic floor muscle at home OTHER

Patients will perform pelvic floor exercises at home.

Home pelvic floor muscle training

Exercises of the pelvic floor muscle in the outpatient OTHER

Patients will perform pelvic floor exercises in the outpatient.

Outpatient pelvic floor muscle training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Fátima Faní Fitz

São Paulo, 05311030, 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, Stress; Motor Activity

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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; Behavior

Study Officials

• Rodrigo A Castro

  Universidade Federal de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: Protocol of group I (Outpatient training): Patients will perform 24 outpatient sessions of pelvic floor muscle (PFM) strength training and home training. At the end of one month, the patients will perform PFM evaluation and training progression Group II protocol (home training): Patients will perform strength training of the pelvic floor muscles daily at home. At the end of one month, the patients will return for consultation, in which the PFM evaluation and training progression will be performed.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: July 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

BR (1)