Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence

NCT ID: NCT02275728

Last Updated: 2014-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-11-30

Brief Summary

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This study evaluates the action of the pelvic floor muscle training with and without EMG Biofeddback in the treatment of stress urinary incontinence in menopausal, peri and post menopausal women and their quality of life before and after the interventions.

Detailed Description

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The Pelvic floor muscle training has been the first line of choice in the treatment of Stress Urinary Incontinence. The goal of this technique is increasing the strength and function of the pelvic floor which aims to support the pelvic viscera, as well as part of their duties, such as locks sphincter muscles.

Risk factors such as advanced age, obesity, multiple pregnancy, can cause a woman to present urinary incontinence (SUI), where the main cause is the dysfunction of the pelvic floor muscles and the lack of awareness of these muscles as well as biomechanical problems.

Some studies describe the use of EMG biofeedback to assess and improve the function of the pelvic floor muscles, however, the studies are not yet conclusive about the action of adding this equipment in the treatment of SUI.

In this regard, the EMG Biofeedback has the ability to physiologically evaluate these disorders and perform a faster treatment for these patients, improving their quality of life. The EMG has the ability to monitor and measure the progression of activation of the pelvic floor muscles, giving feedback to the patient and therapist about the actual condition of muscle function.

Conditions

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Menopause Urinary Incontinence, Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pelvic Floor Muscle Training(PFMT)

The conducted training by two groups, consisting of phasic contractions (3 sets of 10 repetitions of maximal contraction for two seconds to double or triple rest), endurance (two sets of six repetitions of sustained contractions of 6-10 seconds with the same rest time) and training effort, requesting the anticipated contraction of the abdominal pelvic floor coughing effort. We used the same protocol in the supine position, sitting and standing, as evolution of the patient. Both were treated 2 times per week, 20 minutes, totaling 8 sessions.

Group Type EXPERIMENTAL

Pelvic floor muscle training

Intervention Type OTHER

assessment and intervention group with a training of the pelvic floor muscles, another group with training of the pelvic floor muscles and electromyographic biofeedback and a control group will be held. All groups respond to a questionnaire of quality of life. At the end, all groups will be reassessed and compare the effectiveness of interventions between groups.

EMG Biofeedback treatment

In this group, the same protocol of the TMAP will be held, however, emg biofeedback is used during training for 20 minutes, 2 times a week, 8 sessions.

Group Type ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type OTHER

assessment and intervention group with a training of the pelvic floor muscles, another group with training of the pelvic floor muscles and electromyographic biofeedback and a control group will be held. All groups respond to a questionnaire of quality of life. At the end, all groups will be reassessed and compare the effectiveness of interventions between groups.

Eletromyography Biofeedback

Intervention Type OTHER

no treatment

In this group, will be held only the initial assessment, you will not receive treatment for a month and will be reevaluated after being serviced this period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic floor muscle training

assessment and intervention group with a training of the pelvic floor muscles, another group with training of the pelvic floor muscles and electromyographic biofeedback and a control group will be held. All groups respond to a questionnaire of quality of life. At the end, all groups will be reassessed and compare the effectiveness of interventions between groups.

Intervention Type OTHER

Eletromyography Biofeedback

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Will be included in this study:

* all women,
* spontaneous free will,
* have knowledge of research and sign the Instrument of Consent -TCLE.
* Menopausal women,
* pre and post-menopause,
* urinary incontinence with the effort

Exclusion Criteria

Will be excluded from the study:

* patients with neurological, cardiovascular, rheumatologic diseases,
* diabetes mellitus,
* chronic lung disease,
* rheumatoid arthritis,
* Enhlers-danlos,
* Sexually Transmitted Diseases (STDs),
* do not submit annual gynecological exams.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Adriane Bertotto

Maria Celeste Osório Wender

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriane Bertotto

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

References

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Kaya S, Akbayrak T, Gursen C, Beksac S. Short-term effect of adding pelvic floor muscle training to bladder training for female urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2015 Feb;26(2):285-93. doi: 10.1007/s00192-014-2517-4. Epub 2014 Sep 30.

Reference Type RESULT
PMID: 25266357 (View on PubMed)

Ayeleke RO, Hay-Smith EJ, Omar MI. Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Database Syst Rev. 2013 Nov 20;(11):CD010551. doi: 10.1002/14651858.CD010551.pub2.

Reference Type RESULT
PMID: 24259154 (View on PubMed)

Dannecker C, Wolf V, Raab R, Hepp H, Anthuber C. EMG-biofeedback assisted pelvic floor muscle training is an effective therapy of stress urinary or mixed incontinence: a 7-year experience with 390 patients. Arch Gynecol Obstet. 2005 Dec;273(2):93-7. doi: 10.1007/s00404-005-0011-4. Epub 2005 Jul 6.

Reference Type RESULT
PMID: 16001201 (View on PubMed)

Other Identifiers

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14-0233

Identifier Type: OTHER

Identifier Source: secondary_id

02605013.9.0000.5327

Identifier Type: -

Identifier Source: org_study_id

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