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The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propiverine hydrochloride ER | Experimental | 45 mg |
|
| Propiverine hydrochloride IR | Active Comparator | 15 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propiverine hydrochloride ER (extended release) | Drug | 45 mg capsule (1x1/d) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reflex volume (cystometry) | Change in reflex volume compared to baseline and compared between the two treatment arms | three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Leak point pressure | Change in LPP compared to baseline and compared between the two treatment arms | three weeks |
| Leak point volume | Change in LPV compared to baseline and compared between the two treatment arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz | Austria | |||||
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| Propiverine hydrochloride IR (immediate release) | Drug | 15 mg tablet (3x1/d) |
|
|
| three weeks |
| Maximum detrusor pressure | Change in maximum p det compared to baseline and compared between the two treatment arms | three weeks |
| Maximum cystometric capacity | Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms | three weeks |
| Bladder compliance | Change in compliance compared to baseline and compared between the two treatment arms | three weeks |
| Change in number of incontinence episodes | Change of incontinence episodes compared to baseline and compared between the two treatment arms | three weeks |
| State of Well-Being Questionnaire | Change of well-beeing compared to baseline and compared between the two treatment arms | three weeks |
| Post void residual volume | Change in PVR compared to baseline and compared between the two treatment arms | three weeks |
| Incidence and severity of adverse events | occurrences and intensity of adverse events or withdrawals over the whole treatment period | three weeks |
| Hagenow |
| Germany |
| Bucharest | Romania |
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D014570 | Urologic Diseases |
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| C015586 | propiverine |
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