To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
Centre européen d'explorations gynécologiques
Paris, France
Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks
Time frame: 8 weeks
Assessment of the discomfort linked to urinary stress incontinence occurring the previous week assessed on a 0 - 100 visual analog scale at 8 weeks
Time frame: 8 weeks
Urodynamic investigation
Time frame: 4 and 8 weeks
Standardised Pad test
Time frame: 4 and 8 weeks
Number of severe urinary stress incontinence episodes
Time frame: 4 and 8 weeks
Number of sanitary napkins used
Time frame: 4 and 8 weeks
Leakage index
Time frame: 4 and 8 weeks
Subjective appreciation of patients
Time frame: 4 and 8 weeks
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