Electricity; Effects, Incontinence Stress, Muscle Weakness Condition, Pelvic Floor Muscle Weakness
Conditions
Keywords
Pelvic Floor Muscle Weakness, Electrical Stimulation, Pelvic Floor Muscle Training
Brief 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.
Interventions
DEVICEEMG-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.
OTHERPelvic 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
Azienda Unita Sanitaria Locale di Piacenza
BEACMED s.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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)
Intervention model description
Multicentric Prospective Clinical Trial with two parallel arms
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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. * 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
Exclusion criteria
* • pregnancy * severe neurological disease (Multiple Sclerosis, Parkinson's disease, spinal cord injury, major stroke or neuromuscular junction diseases) * previous operation for cancer or radiotherapy in the lower abdomen * Prior surgical intervention for urinary incontinence within the past 12 months * Hysterectomy within 12 months * voiding dysfunction * pelvic pain * severe prolapse (≥ grade 3) * recurrent urinary tract infection * pelvic or disseminated malignancies * women who were virgo intacta * women who declined vaginal examinations for any reasons * before four months of pregnancy * Having significant cognitive impairment or dementia * Unsafe to exercise (severe cardiopulmonary disease) * Unable/unwilling to provide informed consent * Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Muscles (PFM) Strength | Baseline, four weeks, 6 and 12 months follow-up | PFM strength by digital palpation done in the lithotomy position |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency/volume chart | Baseline, four weeks, 6 and 12 months follow-up | The change incontinence frequency (n.of episodes) deducted by frequency/volume chart |
| International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) | 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) |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORGianfranco Lamberti, MD
Azienda USL Piacenza
Outcome results
None listed