Stress Urinary Incontinence in Women
Conditions
Keywords
Stress urinary incontinence, Pelvic floor muscle training
Brief summary
This study will evaluate the safety, tolerability and efficacy of duloxetine and pelvic floor muscle training in women who suffer from stress urinary incontinence
Detailed description
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
Interventions
BEHAVIORALPelvic 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.
Sponsors
Comenius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Woman's willing to provide written informed consent * Women over 18 years that experience uncomplicated stress urinary incontinence * Score of the International Consultation on Urinary Incontinence Questionnaire ≥ 14 points * Symptoms of urinary incontinence for at least 3 consecutive months * Have at least seven urinary incontinence episodes per week * Degree of pelvic organ prolapse ≤ 2 stage * Willingness to accept the randomization process and fully participate in tests
Exclusion criteria
* Recent use of any pharmacologic agent used to treat symptoms of urinary incontinence in the past six months * History of anti-incontinence surgery in the past 12 months * Use of onabotulinumtoxinA for the treatment of urinary incontinence in the past 12 months * History of pelvic prolapse repair or urethral surgery in the past 12 months * History of pelvic floor muscle training in the past 12 months * History of interstitial cystitis or bladder-related pain * Chronic severe constipation * Clinically significant renal or hepatic impairment * Clinically significant heart impairment * Pregnant woman, lactating, or actively trying to become pregnant * Non-compliance with limitation of duloxetine treatment for mixed urinary incontinence * Positive urinary tract infection * Use of rehabilitation aids (pessary, urethral plugs, vaginal beads, etc.) * Use of antidepressant therapy * Insufficient understanding of pelvic floor exercises and/or omitting exercises * Participation in any clinical study in the past six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in incontinence episode frequency | over 12 weeks of treatment | The investigators will compare change in incontinence episode frequency in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL) | over 12 weeks of treatment | 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. |
| Change in Patient Global Impression of Improvement (PGI-I score) | over 12 weeks of treatment | 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. |
| Incidence of adverse events | over 12 weeks of treatment | To examine incidence of adverse events in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone |
Countries
Slovakia
Outcome results
None listed