Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment
Primary Purpose
Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Perineal Rehabilitation protocol
Kari Bo protocol
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum, conservative treatment
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active Perineal Rehabilitation protocol
Kari Bo protocol
Arm Description
study group that will be treated with "Active Perineal Rehabilitation" protocol
control group will be treated with the protocol already widely used
Outcomes
Primary Outcome Measures
Urinary loss frequency
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and stress test
Secondary Outcome Measures
Quality of life
Incontinence quality of life questionnaire
Sexual satisfaction
Female sexual function index
Full Information
NCT ID
NCT02501317
First Posted
July 10, 2015
Last Updated
July 15, 2015
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02501317
Brief Title
Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment
Official Title
Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum, conservative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Perineal Rehabilitation protocol
Arm Type
Experimental
Arm Description
study group that will be treated with "Active Perineal Rehabilitation" protocol
Arm Title
Kari Bo protocol
Arm Type
Active Comparator
Arm Description
control group will be treated with the protocol already widely used
Intervention Type
Behavioral
Intervention Name(s)
Active Perineal Rehabilitation protocol
Intervention Description
Active Perineal Rehabilitation Protocol available in http://www.perineo.info/wordpress/book-active-perineal-rehabilitation/
Intervention Type
Behavioral
Intervention Name(s)
Kari Bo protocol
Intervention Description
Group exercises to pelvic floor rehabilitation
Primary Outcome Measure Information:
Title
Urinary loss frequency
Description
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and stress test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Incontinence quality of life questionnaire
Time Frame
6 months
Title
Sexual satisfaction
Description
Female sexual function index
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laira Ramos, master
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment
We'll reach out to this number within 24 hrs