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

Primary Purpose

Menopause, Urinary Incontinence, Stress

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic floor muscle training
Eletromyography Biofeedback
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring Menopause, Stress Urinary Incontinence, EMG Biofeedback, Pelvic Floor Muscle Training, Quality of life, Physical Therapie

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Pelvic Floor Muscle Training(PFMT)

    EMG Biofeedback treatment

    no treatment

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    October 21, 2014
    Last Updated
    October 24, 2014
    Sponsor
    Federal University of Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02275728
    Brief Title
    Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    November 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Rio Grande do Sul

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menopause, Urinary Incontinence, Stress
    Keywords
    Menopause, Stress Urinary Incontinence, EMG Biofeedback, Pelvic Floor Muscle Training, Quality of life, Physical Therapie

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pelvic Floor Muscle Training(PFMT)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    EMG Biofeedback treatment
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    no treatment
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Pelvic floor muscle training
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Eletromyography Biofeedback
    Primary Outcome Measure Information:
    Title
    Evaluation of pelvic floor muscle strength with "Oxford Scale"
    Description
    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
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    The myoelectric activity evaluation of the pelvic floor
    Description
    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
    Time Frame
    1month
    Other Pre-specified Outcome Measures:
    Title
    Measuring quality of life throughInternational Consultation on Incontinence Questionnaire
    Description
    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)
    Time Frame
    1 month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adriane Bertotto
    Organizational Affiliation
    Federal University of Rio Grande do Sul
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25266357
    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. Epub 2014 Sep 30.
    Results Reference
    result
    PubMed Identifier
    24259154
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    16001201
    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. doi: 10.1007/s00404-005-0011-4. Epub 2005 Jul 6.
    Results Reference
    result

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

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