Improving weak pelvic floor muscles with training and electrostimulation

Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial

This study tests if combining pelvic floor muscle training with a special type of electrical stimulation can help women with weak pelvic floor muscles and stress urinary incontinence feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Azienda Unita Sanitaria Locale di Piacenza (Academic / other)
• Locations: 1 site (Fiorenzuola d'Arda, PC)
• Trial ID: NCT06419517 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness of surface electromyography (s-EMG)-triggered electrostimulation combined with pelvic floor muscle training in women suffering from pelvic floor dysfunction. The study will assess whether this combined approach can enhance pelvic floor muscle strength and reduce leakage in those with Stress Urinary Incontinence (SUI). Participants will engage in a 12-week intervention involving both training and electrostimulation, with their progress monitored through compliance logs and physical evaluations.

Who should consider this trial

Good fit: Ideal candidates are adult women aged 18 to 50 who have very weak pelvic floor muscles and experience frequent leakage episodes.

Not a fit: Patients who are pregnant or have severe neurological diseases or other significant pelvic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve pelvic floor muscle strength and reduce urinary leakage in women with pelvic floor dysfunction.

How similar studies have performed: While there is some evidence supporting the use of electrical stimulation for stress urinary incontinence, the existing studies have shown low quality, indicating that this approach is still being explored.

Eligibility criteria

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.

Where this trial is running

Fiorenzuola d'Arda, PC

• OSPEDALE FIORENZUOLA d'ARDA — Fiorenzuola d'Arda, PC, Italy (Recruiting)

Study contacts

• Principal investigator: Gianfranco Lamberti, MD — Azienda USL Piacenza
• Study coordinator: Gianfranco Lamberti, MD

Conditions Pelvic Floor Muscle Weakness; Incontinence Stress; Electricity; Effects; Muscle Weakness Condition; Electrical Stimulation; Pelvic Floor Muscle Training