Overview

This trial is active, not recruiting.

Conditions menopause, urinary incontinence, stress
Treatments pelvic floor muscle training, eletromyography biofeedback
Sponsor Federal University of Rio Grande do Sul
Start date May 2014
End date September 2014
Trial size 45 participants
Trial identifier NCT02275728, 02605013.9.0000.5327, 14-0233

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
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.
(Active Comparator)
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 Intervention)
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.

Primary Outcomes

Measure
Evaluation of pelvic floor muscle strength with "Oxford Scale"
time frame: 1 month

Secondary Outcomes

Measure
The myoelectric activity evaluation of the pelvic floor
time frame: 1month

Eligibility Criteria

Female participants from 50 years up to 65 years old.

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.

Additional Information

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.
Principal investigator Adriane Bertotto
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Federal University of Rio Grande do Sul.