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Clinical Trials/NCT02275728
NCT02275728
Unknown
Not Applicable

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.

Federal University of Rio Grande do Sul0 sites45 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Menopause
Sponsor
Federal University of Rio Grande do Sul
Enrollment
45
Primary Endpoint
Evaluation of pelvic floor muscle strength with "Oxford Scale"
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Federal University of Rio Grande do Sul
Responsible Party
Principal Investigator
Principal Investigator

Adriane Bertotto

Maria Celeste Osório Wender

Federal University of Rio Grande do Sul

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.

Outcomes

Primary Outcomes

Evaluation of pelvic floor muscle strength with "Oxford Scale"

Time Frame: 1 month

The evaluation consists in bidigital intravaginal test which evaluates the pelvic floor muscle strength using the following 0-5 scale, where 0 = no contraction and 5 = maximal contraction with support against gravity The graduates range from 0 - 5 = 0 has no muscle contraction, 1 = outline of muscle contraction, 2 = contracts without support against gravity, 3 = contracts and holds little against gravity, 4 = contracts and holds up to 6 seconds against gravity and 5 = contracts and holds more than 6 seconds against gravity ntravaginal bidigital test that evaluates scale of pelvic floor muscle strength. The graduates range from 0 - 5 = 0 has no muscle contraction, 1 = outline of muscle contraction, 2 = contracts without support against gravity, 3 = contracts and holds little against gravity, 4 = contracts and holds up to 6 seconds against gravity and 5 = contracts and holds more than 6 seconds against gravity

Secondary Outcomes

  • The myoelectric activity evaluation of the pelvic floor(1month)

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