Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence
NCT ID: NCT02275728
Last Updated: 2014-10-27
Study Results
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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UNKNOWN
NA
45 participants
INTERVENTIONAL
2014-05-31
2014-11-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
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.
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.
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.
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.
Eletromyography Biofeedback
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.
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.
Eletromyography Biofeedback
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
65 Years
FEMALE
No
Sponsors
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Federal University of Rio Grande do Sul
OTHER
Responsible Party
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Adriane Bertotto
Maria Celeste Osório Wender
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.
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.
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.
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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