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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02275728
Enrollment
45
Registered
2014-10-27
Start date
2014-05-31
Completion date
2014-11-30
Last updated
2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Urinary Incontinence, Stress

Keywords

Menopause, Stress Urinary Incontinence, EMG Biofeedback, Pelvic Floor Muscle Training, Quality of life, Physical Therapie

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.

Interventions

OTHERPelvic 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.

OTHEREletromyography Biofeedback

Sponsors

Federal University of Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of pelvic floor muscle strength with Oxford Scale1 monthThe 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

MeasureTime frameDescription
The myoelectric activity evaluation of the pelvic floor1monthThe myoelectric activity evaluation of the pelvic floor \[Time Frame: 1month\] \[Safety Issue: No\] assessment of myoelectric record by EMG biofeedback through an intra-cavity disposable electrode which evaluates the initial and final rest in 60 seconds, the average of three maximal voluntary contractions, time of sustained contraction, number of peaks of contraction in 10 seconds and the test effort requesting cough

Other

MeasureTime frameDescription
Measuring quality of life throughInternational Consultation on Incontinence Questionnaire1 monthIs a brief instrument, translated into Portuguese, presents its psychometric properties such as validity, reliability and responsiveness previously tested, consists of three questions related to frequency, severity of urinary loss and its impact on QoL. Presents a range of eight items assess the possible causes or situations of urinary loss. The ICIQ score (ICIQ E) is the sum of scores for questions three, four and five and ranges from 0 to 21 The impact on QoL is defined according to the score of question 5: (0)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026