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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
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 10, 2015
    Last Updated
    July 15, 2015
    Sponsor
    Federal University of São Paulo
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    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

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