Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder (BryoSoliP)
|ClinicalTrials.gov Identifier: NCT02129816|
Recruitment Status : Terminated
First Posted : May 2, 2014
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Urge Urinary Incontinence||Drug: Bryophyllum||Phase 2 Phase 3|
- In a US nation-wide survey, lower urinary tract symptoms are one of the strongest predictors that patients will seek complementary and alternative medicine (CAM) care. In comparison to general gynecological patients, urogynecological patients are particularly prone to seek help in CAM. Moreover out of the different CAM options, herbal medication is one of the most preferred treatments. However, the effectiveness of CAM regarding OAB has not yet been adequately and objectively evaluated. Therefore, it is timely and essential to elucidate the mode of action as well as to prove efficacy of herbal treatments by a translational approach including comprehensive in vitro experimentation and randomized controlled clinical trials. Bryophyllum pinnatum and specially the flavonoid components have shown a muscle relaxing effect on porcine bladder strips.
- Study Design: Multicenter, prospective, double-blind randomized, placebo-controlled cross-over study, phase III to test the superiority of Bryophyllum pinnatum (BP) over placebo in the treatment of overactive bladder.
- In this cross-over trial a total of 30 patients is needed to proof the superiority of BP over placebo (5 randomization blocs, each 6 patients). Each patient gets each of the three study drugs (BP, Solifenacin, Placebo) in a double-blind randomization. The number of patients was calculated in a post-hoc analysis based on the primary endpoint of a previous study (reduction of micturition rates/24hours; 9.5 (SD2.2) before and 7.8 (SD1.2) after Bryophyllum versus 9.3 (SD1.8) before and 9.1(SD1.6) after placebo), under the assumption of a normal data distribution and a power of 80% a patient number of 2x20. Plus 10% for non-parametric tests in the case of a non-normal distribution (Wilcoxon) were added, what generated a number of 2x22 patients.
- In order to facilitate an equality in the randomization, the investigator choose a cross-over design. Due to the length of the study time, the drop-out rate was risen from 10 to 20% what yielded under the assumption of a equal block randomization the number of 30 patients. Additionally, an explorative arm containing the standard medication Vesicare was inserted, as this is of great clinical interest. For this explorative comparative arm are no existing data that would allow to do a power calculation.
- This follow-up study will give a compelling answer on the efficacy or non-efficacy of BP as well as the safety of BP in respect to placebo and possible answers of its position regarding the standard medication Vesicare.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Patients With Overactive Bladder With Bryophyllum Pinnatum Versus Solifenacinsuccinat Versus Placebo: Multicenter, Prospective, Double-blind Randomized, Placebo-controlled Cross-over Study, Phase III Trial|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||April 20, 2016|
|Actual Study Completion Date :||July 9, 2017|
Active Comparator: Bryophyllum
50% in 350mg Lactose, 2-2-2
Placebo Comparator: Placebo
Lactose 350mg, 2-2-2
10mg in 350mg Lactose, 2-2-2
- Change of the micturition frequency [ Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks ]assessment of the voiding frequency in the 3-day bladder at visit 2,3,4,5,6
- Changes in quality of life parameters [ Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks ]assessment with quality of life and symptom burden questionnaires at visit 2,3,4,5,6 (questionnaires ICIQ-OAB and KHQ)
- Voiding diary parameters [ Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks ]3-day bladder diary returned at visit 2,3,4,5,6
- Assessments of the patient's compliance [ Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks ]drug intake protocol and counting of the returned tablets
- Assessment of AE/SAE [ Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks ]AE/SAE protocol
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129816
|Gynecologic Department, University Hospital Zurich|
|Zurich, Switzerland, 8091|
|Gynecology Department, University Hospital Zurich|
|Zurich, Switzerland, 8091|