Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment
|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: 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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- Urinary loss frequency [ Time Frame: 6 months ]International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and stress test
- Quality of life [ Time Frame: 6 months ]Incontinence quality of life questionnaire
- Sexual satisfaction [ Time Frame: 6 months ]Female sexual function index
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
|Principal Investigator:||Laira Ramos, master||Federal University of Sao Paulo|