search
Back to results

Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

Primary Purpose

Urinary Incontinence, Stress

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercises of the pelvic floor muscle at home
Exercises of the pelvic floor muscle in the outpatient
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring Urinary Incontinence, Stress, Pelvic Floor; Exercise, Physical Therapy Modalities

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fátima Faní Fitz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Home pelvic floor muscle training

Outpatient pelvic floor muscle training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in pad test
To quantify the severity of SUI and as the tool to estimate objective cure rate

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2017
Last Updated
February 6, 2018
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT03058042
Brief Title
Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence
Official Title
Outpatient Pelvic Floor Muscle Training Versus Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
Urinary Incontinence, Stress, Pelvic Floor; Exercise, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home pelvic floor muscle training
Arm Type
Experimental
Arm Description
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.
Arm Title
Outpatient pelvic floor muscle training
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercises of the pelvic floor muscle at home
Intervention Description
Patients will perform pelvic floor exercises at home.
Intervention Type
Other
Intervention Name(s)
Exercises of the pelvic floor muscle in the outpatient
Intervention Description
Patients will perform pelvic floor exercises in the outpatient.
Primary Outcome Measure Information:
Title
Change in pad test
Description
To quantify the severity of SUI and as the tool to estimate objective cure rate
Time Frame
Baseline, after 3 months of treatment
Secondary Outcome Measure Information:
Title
Change in 7-Day Voiding Diary
Description
To assess the loss efforts
Time Frame
Baseline and after 3 months of treatment
Title
Change in pelvic floor muscle function (Oxford Grading Scale)
Description
To assess the function of the pelvic floor muscle
Time Frame
Baseline and after 3 months of treatment
Title
Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
Description
To quantify the impact of SUI on quality of life
Time Frame
Baseline and after 3 months of treatment
Title
Subjective cure of SUI ("satisfied" or "dissatisfied")
Description
To evaluate the patient satisfaction with treatment
Time Frame
Baseline and after 3 months of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo A Castro
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Fátima Faní Fitz
City
São Paulo
ZIP/Postal Code
05311030
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

We'll reach out to this number within 24 hrs