- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04339010
Effect of Hypopressive Gymnastics Associated or Not With Pelvic Floor Muscle Training in Women With Urinary Incontinence
Study Overview
Status
Intervention / Treatment
Detailed Description
This was a single-blind randomized controlled trial comparing the effect of AHT versus AHT associated with PFM contraction in incontinent women. The study was approved by the Research Ethics of Santa Catarina State University (number 3.712.850) and each participating provided the written informed consent signed. Women were randomly assigned to either an AHT group or the AHT associated with PFM contraction (AHT + PFMC) group. The first group underwent a hypopressive exercise program that does not stimulate the PFM contraction, while the other group receives the AHT associated with PFM contraction stimulated by the physiotherapist during the sessions. Following eligibility screening by the research, the women were allocated in an of the two groups. Group allocation results were concealed by opaque, sealed envelopes with serial numbers, and the participants were assigned at the second visit by opening envelops in a sequential manner, after their eligibility was assessed at the first visit. Study investigators were blinded to treatment allocation. Participants underwent a five weeks intervention after the first evaluation, and the final evaluation occurred one week later on a date according to the participant availability.
The first three sessions were designated to learn how to perform the exercises and your variations correctly were part of the five weeks intervention. The intervention was performed in a forty-minute training session in two-week meetings during five consecutive weeks. All women included in this trial, independently of the group, received standardized lifestyle advice including, when appropriate, instructions about weight loss, constipation, hydration and the avoidance of heavy lifting. It is very important to emphasize that the time dedicated to performing the daily exercises was similar. The therapist applying the protocol was appropriately trained especially for the trial and it was not the same professional who conducted the evaluations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Santa Catarina
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Florianópolis, Santa Catarina, Brazil, 88080-350
- Center for Health and Sport Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:18 years old and older, and having a complaint or diagnosis of urinary incontinence.
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Exclusion Criteria: women will be excluded if they had diseases affecting the muscular and nerve tissues, chronic degenerative and/or cerebrovascular disease, or neurological conditions, or had previously undergone pelvic floor re-education programs. Besides that, only women with the ability to correctly contract their PFM proceeded to intervention.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypopressive
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The hypopressive exercise is performed mainly via transversus abdominis (Tra) activation.
The exercise relaxes the diaphragm, decreases intra-abdominal pressure and may activate the abdominal and PFM simultaneously.
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Active Comparator: Hypopressive + PFMC
This group receives the same protocol than the Hypopressive group, but with a verbal command to realize the PFM contraction during the activation of the deep abdominal muscle.
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The hypopressive exercise is performed mainly via transversus abdominis (Tra) activation.
The exercise relaxes the diaphragm, decreases intra-abdominal pressure and may activate the abdominal and PFM simultaneously.
Pelvic floor muscle contraction (PFMC) is performed through a sequence of contraction and relax the PFM.
It will improve PFM strength and is effective for treating urinary incontinence.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary incontinence symptoms
Time Frame: Pre intervention and 1 week post intervention
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Will be assessed by evaluating the ICIQ-SF questionnaire that assesses the frequency, severity, and impact on the quality of life of urinary incontinence (UI).
The three scored items of the ICIQ-UI SF are: [1] ''How often do you leak urine?''
(0 ''Never" 1 ''About once a week or less often,'' 2 ''Two or three times a week,'' 3 ''About once a day,'' 4 ''Several times a day,'' 5 ''All the time''), [2] ''How much urine do you usually leak?''
(0 ''None,'' 2 ''A small amount,'' 4 ''A moderate amount,'' and 6 ''A large amount''), and [3] ''Overall, how much does leaking urine interfere with your everyday life?''
(Visual analog scale ranging from 0 ''Not at all'' to 10 ''A great deal'').
The answers result in a sum, with a minimum score of 0, and a maximum score of 21.
Preliminary cut-off scores were set to 0 as ''continent status'' and 1 or more as ''incontinence status".
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Pre intervention and 1 week post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal voluntary contraction
Time Frame: Pre intervention and 1 week post intervention
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Peritron 9300® manometer will be used to assess the maximum voluntary contraction (MVC).
An MVC of PFM will be asked to the participant and the peak value was recorded, this process was repeated 3 times.
The mean value of these three pressure peaks corresponded to MVC of the PFM.
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Pre intervention and 1 week post intervention
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Vaginal resting pressure
Time Frame: Pre intervention and 1 week post intervention
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The Peritron manometer will be inserted into the vaginal canal and a rest period was given to control the influence of possible voluntary and involuntary contractions, in order to obtain the vaginal resting pressure measurement .
The vaginal resting pressure value will be determined by the lowest pressure value during rest.
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Pre intervention and 1 week post intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypopressive gymnastics
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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