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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• • 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

Locations
Other Locations
Italy
OSPEDALE FIORENZUOLA d'ARDA
RECRUITING
Fiorenzuola D'arda
Contact Information
Primary
Gianfranco Lamberti, MD
g.lamberti2@ausl.pc.it
+390523404657
Backup
Gianluca Ciardi, MD
g.ciardi@ausl.pc.it
+390523404657
Time Frame
Start Date: 2024-05-17
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 50
Treatments
Experimental: Supervised Pelvic Floor Muscle Training + 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.
Active_comparator: Supervised PFMT + sham EMG-triggered ES)
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.
Sponsors
Leads: Azienda Unita Sanitaria Locale di Piacenza
Collaborators: BEACMED s.r.l.

This content was sourced from clinicaltrials.gov

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