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.

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.

Study Overview

• Status: Unknown
• Conditions: Menopause; Urinary Incontinence, Stress
• Intervention / Treatment: Other: Pelvic floor muscle training; Other: Eletromyography Biofeedback

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic Floor Muscle Training(PFMT); 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; 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: EMG Biofeedback treatment; 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; 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.; Other: Eletromyography Biofeedback
No Intervention: no treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The myoelectric activity evaluation of the pelvic floor	The 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	1month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring quality of life throughInternational Consultation on Incontinence Questionnaire	Is 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)	1 month

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Adriane Bertotto, Federal University of Rio Grande do Sul

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Quality of life; Menopause; Stress Urinary Incontinence; Pelvic Floor Muscle Training; EMG Biofeedback; Physical Therapie
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 02605013.9.0000.5327; 14-0233 (Other Identifier: Comitê de Ética Hospital de Clínicas)