Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder

• Status: Terminated
• Trial end date: 2017-07-09
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborators: Dr. med. David Scheiner; Dr. med. Matthias Werner; PD Dr. med. Verena Geissbühler; Prof. pharm. Ursula von Mandach
• Treatments: Solifenacin Succinate

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