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Status unknownNCT02275728Updated Oct 27, 2014

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

An interventional study of Pelvic floor muscle training and Eletromyography Biofeedback in Menopause and Urinary Incontinence, Stress, sponsored by Federal University of Rio Grande do Sul. Status unknown. Open to female participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-27.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Menopause
  • Urinary Incontinence, Stress

Keywords

  • Menopause
  • Stress Urinary Incontinence
  • EMG Biofeedback
  • Pelvic Floor Muscle Training
  • Quality of life
  • Physical Therapie
03

In context

Urinary Incontinence, Stress

670 studies on the registry are indexed under Urinary Incontinence, Stress; 122 are open to participants now.

This study's enrollment of 45 is below the median of 69 across 520 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Federal University of Rio Grande do Sul is the lead sponsor of 121 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
45 participants (actual)

Study arms

  • 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

  • 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 · 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.

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
06

What researchers measure

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

    Time frame: 1 month

Secondary outcomes

  1. 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

    Time frame: 1month

Other outcomes

  1. 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)

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 25266357 ↗
  • 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. PubMed 24259154 ↗
  • 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. PubMed 16001201 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02275728
Responsible party
Adriane Bertotto (Maria Celeste Osório Wender, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Oct 27, 2014
Start date
May 2014
Primary completion
Sep 2014
Completion
Nov 2014 (estimated)
Last update
Oct 27, 2014

Study contacts

Adriane Bertotto
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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