Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor (NCT06419517) | Clinical Trial Compass
CompletedNot Applicable
Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor
Italy50 participantsStarted 2024-05-17
Plain-language summary
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)
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Pelvic Floor Muscles (PFM) Strength
Timeframe: Baseline, four weeks, 6 and 12 months follow-up