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

Menopause Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02275728
• Other study ID #: 02605013.9.0000.5327
• Secondary ID: 14-0233
• Status: Active, not recruiting
• Phase: N/A
• First received: October 21, 2014
• Last updated: October 24, 2014
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.
• Eletromyography Biofeedback

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

References & Publications (3)

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 — View Citation

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. Epub — View Citation

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No