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Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

Recruiting
18-50 years
Female
Phase N/A

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Overview

This research will determine 1) whether the very weak pelvic floor can be improved with surface electromyography (s-EMG)-triggered electrostimulation added to pelvic floor muscle training and 2) whether sEMG-triggered electrostimulation added to pelvic floor muscle training can reduce leakage in Stress Urinary Incontinence (SUI)

Description

Among women with pelvic floor dysfunction, it has long been known that PFM training is the first-line therapy for stress incontinence. One of the difficulties that clinicians often find upon examination is that many women present a very weak pelvic floor and are unable to contract their PFM. There is overwhelming evidence to show that conservative treatment in the form of pelvic muscle exercises (and to a lesser degree, electrotherapy, and vaginal weight therapy) is effective in the treatment of stress urinary incontinence. To date, there is some evidence to support the use of electrical stimulation for stress urinary incontinence in women, but we are still very uncertain about the full potential of this treatment because of the low quality of the existing evidence.

Eligibility

Inclusion Criteria:

  • • Adult women (18 years old - 50 years old), with a Modified Oxford Score, determined by digital palpation, of 0 - 1, complaining leakage episode occurring more than once a week.
    • Between six and eighteen months after childbirth
    • Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
    • Willing and able to undergo an extensive physical function evaluation

Exclusion Criteria:

  • • pregnancy
    • severe neurological disease (Multiple Sclerosis, Parkinson's disease, spinal cord injury, major stroke or neuromuscular junction diseases)
    • previous operation for cancer or radiotherapy in the lower abdomen
    • Prior surgical intervention for urinary incontinence within the past 12 months
    • Hysterectomy within 12 months
    • voiding dysfunction
    • pelvic pain
    • severe prolapse (≥ grade 3)
    • recurrent urinary tract infection
    • pelvic or disseminated malignancies
    • women who were virgo intacta
    • women who declined vaginal examinations for any reasons
    • before four months of pregnancy
    • Having significant cognitive impairment or dementia
    • Unsafe to exercise (severe cardiopulmonary disease)
    • Unable/unwilling to provide informed consent
    • Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.

Study details
    Pelvic Floor Muscle Weakness
    Incontinence Stress
    Electricity; Effects
    Muscle Weakness Condition

NCT06419517

Azienda Unità Sanitaria Locale di Piacenza

28 May 2024

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