OSPEDALE FIORENZUOLA d'ARDA
Fiorenzuola d'Arda, PC, 29017, Italy
NCT Number: NCT06419517
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)
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Fiorenzuola d'Arda, PC, 29017, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: 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).
Other names: EMG-triggered ES
Time frame: Baseline, four weeks, 6 and 12 months follow-up
PFM strength by digital palpation done in the lithotomy position
Time frame: Baseline, four weeks, 6 and 12 months follow-up
The change incontinence frequency (n.of episodes) deducted by frequency/volume chart
Time frame: 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)
Azienda Unita Sanitaria Locale di Piacenza
Other
Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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