Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder

Overactive Bladder Clinical Trial

— BryoSoliP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02129816
• Other study ID #: BryoSoliP-2014
• Secondary ID: KEK 2012-0530 (Z
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 25, 2014
• Last updated: October 24, 2017
• Start date: May 2014
• Est. completion date: July 9, 2017

Study information

• Verified date: October 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 9, 2017
• Est. primary completion date: April 20, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• OAB (>8 micturitions/24 hours, associated with urge symptoms)

• postmenopausal women

• cystoscopy to exclude a bladder carcinoma or carcinoma in situ

• written and oral informed consent

Exclusion Criteria:

• urinary tract infection in an intermittent catheter asservated sample (>1000 bacterias/ml)

• intake of bladder affecting drugs like anticholinergics, diuretics, muscle relaxing medications and phytotherapeutics in the last three months

• neurological conditions such as stroke, multiple sclerosis, spinal cord injury or Parkinsons's disease

• postvoid residual volume =100 ml

• lactose intolerance

• contraindication for Solifenacin

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urge Urinary Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Drug:
• Bryophyllum

Locations

Country	Name	City	State
Switzerland	Gynecologic Department, University Hospital Zurich	Zurich
Switzerland	Gynecology Department, University Hospital Zurich	Zurich

Sponsors (5)

Lead Sponsor	Collaborator
University of Zurich	Dr. med. David Scheiner, Dr. med. Matthias Werner, PD Dr. med. Verena Geissbühler, Prof. pharm. Ursula von Mandach

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Betschart C, von Mandach U, Seifert B, Scheiner D, Perucchini D, Fink D, Geissbühler V. Randomized, double-blind placebo-controlled trial with Bryophyllum pinnatum versus placebo for the treatment of overactive bladder in postmenopausal women. Phytomedici — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Voiding diary parameters	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
Secondary	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
Secondary	Assessment of AE/SAE	AE/SAE protocol	participants will be followed for the duration of the study, an expected average of 35 weeks