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Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

NCT06419517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-03

No results posted yet for this study

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)

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • BEACMED s.r.l.

    collaborator UNKNOWN

  • Azienda Unita Sanitaria Locale di Piacenza

    lead OTHER

Principal Investigators

  • Gianfranco Lamberti, MD · Azienda USL Piacenza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419517 on ClinicalTrials.gov