Clinical trial NCT02275728: Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence
Official title: Evaluating the Effectiveness of Pelvic Floor Muscle Training With and Without EMG Biofeedback and Quality of Life in Peri and Postmenopausal Women With Stress Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menopause
Urinary Incontinence, Stress
Keywords: Menopause
Stress Urinary Incontinence
EMG Biofeedback
Pelvic Floor Muscle Training
Quality of life
Physical Therapie
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 45
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of pelvic floor muscle strength with "Oxford Scale"
timeFrame: 1 month
Secondary outcomes:
measure: The myoelectric activity evaluation of the pelvic floor
timeFrame: 1month
Other outcomes:
measure: Measuring quality of life throughInternational Consultation on Incontinence Questionnaire
timeFrame: 1 month
Locations:
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Adriane Bertotto
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.