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The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.
This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mictonetten 5 mg, coated tablet | Drug | propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW) |
|
| Measure | Description | Time Frame |
|---|---|---|
| voiding frequency | before therapy and at end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| voided volume | before and at end of treatment | |
| incontinence episodes per day | before and at end of therapy | |
| safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Marschall-Kehrel, MD | urologist | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18502028 | Derived | Marschall-Kehrel D, Feustel C, Persson de Geeter C, Stehr M, Radmayr C, Sillen U, Strugala G. Treatment with propiverine in children suffering from nonneurogenic overactive bladder and urinary incontinence: results of a randomized placebo-controlled phase 3 clinical trial. Eur Urol. 2009 Mar;55(3):729-36. doi: 10.1016/j.eururo.2008.04.062. Epub 2008 May 7. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C015586 | propiverine |
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| placebo | Drug | placebo corresponding to body weight |
|
| before and at end of treatment |
| 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 |
| D014555 | Urination Disorders |