Urinary IncontinenceNCT02501317
Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment
A study testing Active Perineal Rehabilitation protocol and Kari Bo protocol in people with Urinary Incontinence, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Active Perineal Rehabilitation protocol and Kari Bo protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosticated with stress urinary incontinence, with stress test positive; and age between 20 to 75 years old.
Who cannot join
- 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
About this study
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
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Active Perineal Rehabilitation protocol, Kari Bo protocol
- Keywords
- urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum, conservative treatment
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Perineal Rehabilitation protocolBehavioural
Active Perineal Rehabilitation Protocol available in http://www.perineo.info/wordpress/book-active-perineal-rehabilitation/
Kari Bo protocolBehavioural
Group exercises to pelvic floor rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Active Perineal Rehabilitation protocol | Experimental | study group that will be treated with "Active Perineal Rehabilitation" protocol Receives: Behavioral: Active Perineal Rehabilitation protocol |
| Kari Bo protocol | Active comparator | control group will be treated with the protocol already widely used Receives: Behavioral: Kari Bo protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary loss frequency
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and stress test
Measured: 6 months
Secondary outcomes (2)
Quality of life
Incontinence quality of life questionnaire
Measured: 6 months
Sexual satisfaction
Female sexual function index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laira Lopes Ramos, Federal University of São Paulo
- Investigators
- Laira Ramos, master, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501317
- Sponsor's protocol ID
- 435522
- Status last verified
- Jul 2015
- First submitted
- 10 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Validation of the "Active Perineal Rehabilitation" Protocol to Urinary Incontinence Treatment
- ClinicalTrials.gov ID
- NCT02501317
- Acronym / sponsor ID
- 435522
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum, conservative treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Perineal Rehabilitation protocol | Experimental | Behavioral: Active Perineal Rehabilitation protocolstudy group that will be treated with "Active Perineal Rehabilitation" protocol |
| Kari Bo protocol | Active comparator | Behavioral: Kari Bo protocolcontrol group will be treated with the protocol already widely used |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women diagnosticated with stress urinary incontinence, with stress test positive; and age between 20 to 75 years old.
Key exclusion criteria (8 listed)
- Pregnancy
- Metallic intrauterine device
- Unable to understand physical therapist orientations
- Urinary infection
- Virginity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Perineal Rehabilitation protocolActive Perineal Rehabilitation Protocol available in http://www.perineo.info/wordpress/book-active-perineal-rehabilitation/ | Behavioural | Active Perineal Rehabilitation protocol |
| Kari Bo protocolGroup exercises to pelvic floor rehabilitation | Behavioural | Kari Bo protocol |
Primary outcome
Urinary loss frequency
Time frame: 6 months
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and stress test
2 secondary outcomes
Quality of life
Time frame: 6 months
Sexual satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laira Ramos, master principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Active Perineal Rehabilitation protocol and Kari Bo protocol in people with Urinary Incontinence, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary loss frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.