This study will evaluate the safety, tolerability and efficacy of duloxetine and pelvic floor muscle training in women who suffer from stress urinary incontinence
This is a randomized-intervention, parallel, multicentric study which will evaluate the safety, tolerability and efficacy of oral duloxetine and innovative pelvic floor muscle training to woman suffering from stress urinary incontinence
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Pelvic floor muscle training (PFMT) with lumbopelvic stabilization. 1. Educating of probands about anatomy, physiology, and pelvic floor muscles functions 2. Training of pelvic floor muscles in different position 3. Training of pelvic floor muscles with lumbopelvic stabilization Exercise 5 times a week for 20-30 minutes a day, after initial training with a physiotherapist.
Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava
Martin, Slovakia
Change in incontinence episode frequency
The investigators will compare change in incontinence episode frequency in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone
Time frame: over 12 weeks of treatment
Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL)
The investigators will compare change in incontinence quality of life in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone. 0 = worst quality of life, 100 = best quality of life.
Time frame: over 12 weeks of treatment
Change in Patient Global Impression of Improvement (PGI-I score)
To examine change in Patient Global Impression of Improvement in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone . 1 = much better. 7 = definitely worse.
Time frame: over 12 weeks of treatment
Incidence of adverse events
To examine incidence of adverse events in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone
Time frame: over 12 weeks of treatment
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