An interventional study of Pelvic floor muscle training (PFMT) with lumbopelvic stabilization in Stress Urinary Incontinence in Women, sponsored by Comenius University. Completed at 1 site in Slovakia. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by Comenius University · Not applicable, Interventional, and Treatment
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
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 158 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Comenius University is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Peroral treatment with duloxetine at a dose of 40 mg twice a day
Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
Peroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.
Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
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.
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
Plan to share: No — After study completion
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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