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| Name | Class |
|---|---|
| BEACMED s.r.l. | UNKNOWN |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised Pelvic Floor Muscle Training + EMG-triggered ES | Experimental | 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. |
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| Supervised PFMT + sham EMG-triggered ES) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMG-triggered ES | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Muscles (PFM) Strength | PFM strength by digital palpation done in the lithotomy position | Baseline, four weeks, 6 and 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency/volume chart | The change incontinence frequency (n.of episodes) deducted by frequency/volume chart | Baseline, four weeks, 6 and 12 months follow-up |
| International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) |
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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.
Exclusion Criteria:
• pregnancy
Person's sense of self
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| Name | Affiliation | Role |
|---|---|---|
| Gianfranco Lamberti, MD | Azienda USL Piacenza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSPEDALE FIORENZUOLA d'ARDA | Fiorenzuola d'Arda | PC | 29017 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30288727 | Result | Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4. | |
| 15014933 | Result | Bo K. Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):76-84. doi: 10.1007/s00192-004-1125-0. Epub 2004 Jan 24. |
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Individual participant data after deidentification
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Multicentric Prospective Clinical Trial with two parallel arms
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Double (participants, principal investigator). To improve the effect of blindness, participants were informed that the trial intended to compare the effects of two Electrical Stimulation (ES) methods for Stress Urinary Incontinence (SUI)
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| Pelvic Floor Muscle Training | Other | 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). |
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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)
| Baseline, four weeks, 6 and 12 months follow-up |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |