Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

Not Applicable

Recruiting

• Conditions: Electricity; Effects; Muscle Weakness Condition; Incontinence Stress; Pelvic Floor Muscle Weakness
• Interventions: Device: EMG-triggered ES; Other: Pelvic Floor Muscle Training

• Registration Number: NCT06419517
• Lead Sponsor: Azienda Unità Sanitaria Locale di Piacenza

Brief 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)

Detailed 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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-16
• Study Start: 2024-05-17
• Study First Posted: 2024-05-17
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-05-11
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised Pelvic Floor Muscle Training + EMG-triggered ES	Pelvic Floor Muscle Training	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.
Supervised Pelvic Floor Muscle Training + EMG-triggered ES	EMG-triggered ES	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.
Supervised PFMT + sham EMG-triggered ES)	Pelvic Floor Muscle Training	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.

Primary Outcome Measures

Name	Time	Method
Pelvic Floor Muscles (PFM) Strength	Baseline, four weeks, 6 and 12 months follow-up	PFM strength by digital palpation done in the lithotomy position

Secondary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)	Baseline, four weeks, 6 and 12 months follow-up	Change of "International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF" scores, which varie from 0 (no impact of incontinence) to 19 (worst impact of incontinence in everyday life)
Frequency/volume chart	Baseline, four weeks, 6 and 12 months follow-up	The change incontinence frequency (n.of episodes) deducted by frequency/volume chart

Trial Locations

Locations (1)

OSPEDALE FIORENZUOLA d'ARDA; 🇮🇹 Fiorenzuola d'Arda, PC, Italy