Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder

NCT ID: NCT02129816

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-07-09

Brief 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).

Detailed 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.

Conditions

Overactive Bladder; Urge Urinary Incontinence

Keywords

Female; Postmenopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bryophyllum

50% in 350mg Lactose, 2-2-2

Group Type: ACTIVE_COMPARATOR

Bryophyllum

Intervention Type: DRUG

Placebo

Lactose 350mg, 2-2-2

Group Type: PLACEBO_COMPARATOR

Bryophyllum

Intervention Type: DRUG

Solifenacin

10mg in 350mg Lactose, 2-2-2

Group Type: EXPERIMENTAL

Bryophyllum

Intervention Type: DRUG

Interventions

Bryophyllum

Intervention Type: DRUG

Other Intervention Names

dried leave press juice; provided by Weleda AG, Arlesheim, Switzerland

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PD Dr. med. Verena Geissbühler

UNKNOWN

Sponsor Role: collaborator

Prof. pharm. Ursula von Mandach

UNKNOWN

Sponsor Role: collaborator

Dr. med. David Scheiner

UNKNOWN

Sponsor Role: collaborator

Dr. med. Matthias Werner

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gynecologic Department, University Hospital Zurich

Zurich, , Switzerland

Gynecology Department, University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 23218404 (View on PubMed)

Other Identifiers

KEK 2012-0530 (Zurich)

Identifier Type: REGISTRY

Identifier Source: secondary_id

BryoSoliP-2014

Identifier Type: -

Identifier Source: org_study_id