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Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment

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ClinicalTrials.gov Identifier: NCT02501317
Recruitment Status : Unknown
Verified July 2015 by Laira Lopes Ramos, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Laira Lopes Ramos, Federal University of São Paulo

Brief Summary:

Introduction: Urinary incontinence is a condition that affects most women in her adult life; it is considered a public health problem and has a high negative impact on the quality of life. Physical therapy is considered as the first treatment option for this disease, these treatments are done with pelvic floor muscles exercises (kinesiotherapy) with or without the use of other resources such as biofeedback, electrical stimulation and vaginal cones. Rationale: The protocols used in the various studies on the treatment of urinary incontinence are made with only one type of therapy and have no change in the intensity of the exercises. The "Active Perineal Rehabilitation" protocol uses kinesiotherapy with biofeedback, electrical stimulation, vaginal cones and home exercises; it consists of 14 individual sessions that gradually evolve the intensity of exercises. Objective: To assess the scientific validity of "Active Perineal Rehabilitation" protocol for the treatment of urinary incontinence. Methodology: A multicenter, prospective clinical trial, controlled and randomized, the sample will be divided into a study group that will be treated with the Active Perineal Rehabilitation protocol, and a control group will be treated with the protocol already widely used.

Keys Words: urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum, conservative treatment


Condition or disease Intervention/treatment Phase
Urinary Incontinence Behavioral: Active Perineal Rehabilitation protocol Behavioral: Kari Bo protocol Not Applicable

Detailed Description:

Urinary incontinence is defined as an involuntary loss of urine, the World Health Organization (WHO) considers it is a public health problem having a negative impact on the quality of life of such patients. Its prevalence ranges from 3% to 55%, it is difficult to have a right number because different definitions used and the range age of the population studied. Its more common type is stress urinary incontinence (SUI), the involuntary loss of urine on exertion, coughing or sneezing.

In the old days, those pathologies were seen as a natural consequence of aging, making people adapt to the changes imposed by them. Modern society and the increase of life expectancy made people care more about their quality of life and well-being, making them search for treatments to those pathologies.

The International Federation of Gynecology and Obstetrics, International Continence Society, as well the most of national societies of gynecology and urology, deliberate that physiotherapy is the first option to urinary incontinence treatment. Perineal rehabilitation aims increase pelvic floor muscle strength, to intensify urethral closure.

Perineal rehabilitation is showing to be an efficient treatment to urinary incontinence, studies show that rate cure is between 28 to 84%, this large interval is because different techniques and different assessments in each study.The treatments used in perineal rehabilitation are kinesiotherapy (pelvic floor muscle exercises), with or without biofeedback, electrical stimulation and vaginal cones.

Although there are several studies about physical therapy to urinary incontinence treatment, there are not studies that use more than one of these techniques. Other problem is the fact that the protocols used in these studies start and finish with the same exercises intensity, there is no evolution in the treatment. It can be observed in the literature review made by Hay-Smith, 2012 and Margarida Ferreira e Paula Santos, 2011.

The "Active Perineal Rehabilitation" (APR) protocol uses perineal kinesiotherapy with biofeedback, electrical stimulation, vaginal cones and home exercises, its intensity increase session by session, like is recommended by American College of Sports Medicine. This protocol is unique and innovative to urinary incontinence treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Perineal Rehabilitation protocol
study group that will be treated with "Active Perineal Rehabilitation" protocol
Behavioral: Active Perineal Rehabilitation protocol
Active Perineal Rehabilitation Protocol available in http://www.perineo.info/wordpress/book-active-perineal-rehabilitation/

Active Comparator: Kari Bo protocol
control group will be treated with the protocol already widely used
Behavioral: Kari Bo protocol
Group exercises to pelvic floor rehabilitation




Primary Outcome Measures :
  1. Urinary loss frequency [ Time Frame: 6 months ]
    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and stress test


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 6 months ]
    Incontinence quality of life questionnaire

  2. Sexual satisfaction [ Time Frame: 6 months ]
    Female sexual function index



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women diagnosticated with stress urinary incontinence, with stress test positive; and age between 20 to 75 years old.

Exclusion Criteria:

  • Pregnancy
  • Metallic intrauterine device
  • Unable to understand physical therapist orientations
  • Urinary infection
  • Virginity
  • Prolapse grade 2 or more
  • Previous pelvic surgery
  • Previous treatment to urinary incontinence in the last 6 months before the study

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): NCT02501317


Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Laira Ramos, master Federal University of Sao Paulo
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Responsible Party: Laira Lopes Ramos, Master, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02501317    
Other Study ID Numbers: 435522
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Keywords provided by Laira Lopes Ramos, Federal University of São Paulo:
urinary incontinence
physical therapy
rehabilitation
pelvic floor
perineum
conservative treatment
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders