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Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058042
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Fatima Fitz, 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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Other: Exercises of the pelvic floor muscle at home Other: Exercises of the pelvic floor muscle in the outpatient Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Outpatient Pelvic Floor Muscle Training Versus Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: Randomized Controlled Trial
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in pad test [ Time Frame: Baseline, after 3 months of treatment ]
    To quantify the severity of SUI and as the tool to estimate objective cure rate


Secondary Outcome Measures :
  1. Change in 7-Day Voiding Diary [ Time Frame: Baseline and after 3 months of treatment ]
    To assess the loss efforts

  2. Change in pelvic floor muscle function (Oxford Grading Scale) [ Time Frame: Baseline and after 3 months of treatment ]
    To assess the function of the pelvic floor muscle

  3. Change in Incontinence Quality-of-Life Questionnaire (I-QoL) [ Time Frame: Baseline and after 3 months of treatment ]
    To quantify the impact of SUI on quality of life

  4. Subjective cure of SUI ("satisfied" or "dissatisfied") [ Time Frame: Baseline and after 3 months of treatment ]
    To evaluate the patient satisfaction with treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058042


Locations
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Brazil
Fátima Faní Fitz
São Paulo, Brazil, 05311030
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Study Director: Rodrigo A Castro Universidade Federal de São Paulo

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Responsible Party: Fatima Fitz, Physiotherapist, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03058042    
Other Study ID Numbers: 001
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatima Fitz, Federal University of São Paulo:
Urinary Incontinence, Stress
Pelvic Floor; Exercise
Physical Therapy Modalities
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders