NCT06419517

Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Azienda Unita Sanitaria Locale di Piacenza · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Floor Muscle Weakness
• Incontinence Stress
• Electricity; Effects
• Muscle Weakness Condition

Interventions

Type	Name	Description
DEVICE	EMG-triggered ES	The ES treatment protocol consisted of daily endovaginal electrostimulation sessions for four weeks. We used a portable unit EVOSTIM ®, which allowed us to use different frequencies and length of impulse and a probe Perisphera ® The average current intensity was adjusted according to the sensation of discomfort in each patient.
OTHER	Pelvic Floor Muscle Training	Standardization of the supervised PFMT To achieve standardization of supervised PFMT treatments, a written protocol for the physiotherapeutic examinations and PFMT program will be provided to the physiotherapists (or nurse or midwife) delivering the treatments (See Additional file).

Timeline

• Start date: 2024-05-17
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-05-17
• Last updated: 2026-02-03

Locations

1 site across 1 country: Italy