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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Duloxetine treatment | Active Comparator | Peroral treatment with duloxetine at a dose of 40 mg twice a day |
|
| Standard Duloxetine treatment with PFMT | Experimental | Peroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor muscle training (PFMT) with lumbopelvic stabilization | Behavioral | Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.
Exercise 5 times a week for 20-30 minutes a day, after initial training with a physiotherapist. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | over 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | over 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
woman with stress urinary incontinence
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava | Martin | 03601 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32852574 | Derived | Hagovska M, Svihra J, Breza J Jr, Dubravicky J, Vargovcak M. A randomized, intervention parallel multicentre study to evaluate duloxetine and innovative pelvic floor muscle training in women with uncomplicated stress urinary incontinence-the DULOXING study. Int Urogynecol J. 2021 Jan;32(1):193-201. doi: 10.1007/s00192-020-04516-w. Epub 2020 Aug 27. | |
| 32028393 |
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After study completion
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 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. |
| 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 | over 12 weeks of treatment |
| Hagovska M, Svihra J. Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(6):e18834. doi: 10.1097/MD.0000000000018834. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |