Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Incontinence, Stress
• Interventions: Other: Exercises of the pelvic floor muscle at home; Other: Exercises of the pelvic floor muscle in the outpatient

• Registration Number: NCT03058042
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Study Start: 2017-07-01
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home pelvic floor muscle training	Exercises of the pelvic floor muscle at home	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.
Outpatient pelvic floor muscle training	Exercises of the pelvic floor muscle in the outpatient	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.

Primary Outcome Measures

Name	Time	Method
Change in pad test	Baseline, after 3 months of treatment	To quantify the severity of SUI and as the tool to estimate objective cure rate

Secondary Outcome Measures

Name	Time	Method
Change in 7-Day Voiding Diary	Baseline and after 3 months of treatment	To assess the loss efforts
Change in pelvic floor muscle function (Oxford Grading Scale)	Baseline and after 3 months of treatment	To assess the function of the pelvic floor muscle
Change in Incontinence Quality-of-Life Questionnaire (I-QoL)	Baseline and after 3 months of treatment	To quantify the impact of SUI on quality of life
Subjective cure of SUI ("satisfied" or "dissatisfied")	Baseline and after 3 months of treatment	To evaluate the patient satisfaction with treatment

Trial Locations

Locations (1)

Fátima Faní Fitz; 🇧🇷 São Paulo, Brazil