Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

Azienda Unita Sanitaria Locale di Piacenza

Status: Completed

Conditions: Muscle Weakness Condition; Incontinence Stress; Pelvic Floor Muscle Weakness; Electricity; Effects

Treatments: Other: Pelvic Floor Muscle Training; Device: EMG-triggered ES

Study type: Interventional

Funder types: Other

Identifiers

NCT06419517

23-0000035

Details and patient eligibility

About

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)

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Supervised Pelvic Floor Muscle Training + EMG-triggered ES

Experimental group

Description:

Group A (supervised PFMT + EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe Frequency: 50 Hz. - Pulse width 250 microseconds Intensity: to motor response (activation of PFM) Number of sessions: 20 Ramp up/down: 1 sec.

Treatment:

Device: EMG-triggered ES

Other: Pelvic Floor Muscle Training

Supervised PFMT + sham EMG-triggered ES)

Active Comparator group

Description:

Group B: Supervised PFMT + sham EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe model xx Frequency: 2 Hz. - Pulse width 10 microseconds Intensity: to sensory response Number of sessions: 20 Ramp up/down: 1 sec.

Treatment:

Other: Pelvic Floor Muscle Training