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

NCT02275728 | Unknown

• 2 other identifiers: 02605013.9.0000.532714-0233
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopause; Urinary Incontinence, Stress

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of pelvic floor muscle strength with "Oxford Scale"

  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

  1 month

Secondary Outcomes (1)

• The myoelectric activity evaluation of the pelvic floor

  1month

Other Outcomes (1)

• Measuring quality of life throughInternational Consultation on Incontinence Questionnaire

  1 month

Study Arms (3)

Pelvic Floor Muscle Training(PFMT)

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.

Other: Pelvic floor muscle training

EMG Biofeedback treatment

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.

Other: Pelvic floor muscle training; Other: Eletromyography Biofeedback

no treatment

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.

Interventions

Pelvic floor muscle training OTHER

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; Pelvic Floor Muscle Training(PFMT)

Eletromyography Biofeedback OTHER

EMG Biofeedback treatment

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Related Publications (3)

• 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.

  PMID: 25266357 RESULT

• 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.

  PMID: 24259154 RESULT

• 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.

  PMID: 16001201 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adriane Bertotto

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maria Celeste Osório Wender

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 27, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 27, 2014

Record last verified: 2014-10