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| ID | Type | Description | Link |
|---|---|---|---|
| KEK 2012-0530 (Zurich) | Registry Identifier | Ethics committee Zurich |
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| Name | Class |
|---|---|
| PD Dr. med. Verena Geissbühler | UNKNOWN |
| Prof. pharm. Ursula von Mandach | UNKNOWN |
| Dr. med. David Scheiner | UNKNOWN |
| Dr. med. Matthias Werner |
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Overactive bladder (OAB) is an enigmatic condition that is treated symptomatically with anticholinergic drugs (gold standard 2013). In a clinical pilot study was found to be a trend for a higher reduction of the micturition frequency in the Bryophyllum pinnatum group - treated with chewing tablets containing 50% of dried BP leaf press juice - than in the placebo group (n=20, p=0.064) Hypothesis: To test the superior effectivity of Bryophyllum versus Placebo in the treatment of OAB with the needed number (Purpose 1) and to assess in an experimental arm the side effects of BP in comparison to the standard drug (Vesicare) in a clincial trial (Purpose 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bryophyllum | Active Comparator | 50% in 350mg Lactose, 2-2-2 |
|
| Placebo | Placebo Comparator | Lactose 350mg, 2-2-2 |
|
| Solifenacin | Experimental | 10mg in 350mg Lactose, 2-2-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bryophyllum | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the micturition frequency | assessment of the voiding frequency in the 3-day bladder at visit 2,3,4,5,6 | participants will be followed for the duration of the study, an expected average of 35 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quality of life parameters | assessment with quality of life and symptom burden questionnaires at visit 2,3,4,5,6 (questionnaires ICIQ-OAB and KHQ) | participants will be followed for the duration of the study, an expected average of 35 weeks |
| Voiding diary parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Department, University Hospital Zurich | Zurich | 8091 | Switzerland | |||
| Gynecology Department, University Hospital Zurich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23218404 | Result | Betschart C, von Mandach U, Seifert B, Scheiner D, Perucchini D, Fink D, Geissbuhler V. Randomized, double-blind placebo-controlled trial with Bryophyllum pinnatum versus placebo for the treatment of overactive bladder in postmenopausal women. Phytomedicine. 2013 Feb 15;20(3-4):351-8. doi: 10.1016/j.phymed.2012.10.007. Epub 2012 Dec 4. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| UNKNOWN |
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3-day bladder diary returned at visit 2,3,4,5,6 |
| participants will be followed for the duration of the study, an expected average of 35 weeks |
| Assessments of the patient's compliance | drug intake protocol and counting of the returned tablets | participants will be followed for the duration of the study, an expected average of 35 weeks |
| Assessment of AE/SAE | AE/SAE protocol | participants will be followed for the duration of the study, an expected average of 35 weeks |
| Zurich |
| 8091 |
| Switzerland |
| 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 |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |