Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

Outpatient Pelvic Floor Muscle Training Versus Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Other: Exercises of the pelvic floor muscle at home; Other: Exercises of the pelvic floor muscle in the outpatient

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05311030
    • Fátima Faní Fitz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Exercises of the pelvic floor muscle at home; Patients will perform pelvic floor exercises at home.
Sham Comparator: 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.	Other: Exercises of the pelvic floor muscle in the outpatient; Patients will perform pelvic floor exercises in the outpatient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Study Director: Rodrigo A Castro, Universidade Federal de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Urinary Incontinence, Stress; Physical Therapy Modalities; Pelvic Floor; Exercise
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No