Bryophyllum Versus Placebo for Overactive Bladder

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

E: The pharmacological effect of Bryophyllum pinnatum could be shown on uterine smooth muscle cells, on spontaneous and oxytocin-stimulated contractions. Smooth muscle relaxation is not only required for preventing premature labour but also for symptom's relief of overactive bladder (OAB). According to previous preclinical and clinical studies, an inhibiting effect of Bryophyllum on OAB is assumed.

20 women are included in this phase 2 drug study, treated with Bryophyllum pinnatum in form of the commercially available Bryophyllum tablets into capsules (verum: 3x2capsules/day) or lactose capsules (placebo: 3x2 capsules/day), 10 women in each group. Duration of the drug administration is 8 weeks.

Primary endpoint is the reduction of micturitions per 24 hours (measured by filling in a voiding dairy), secondary endpoints are the improvement of quality of life (measured by using the King's Health Questionnaire and the ICIQ-OAB, two questionnaires, validated for the german language, for women with incontinence), increase of the micturition volumes and reduction of urge episodes (measured by the patients and recorded in a voiding dairy) and the registration of adverse events during the study phase. Ethics committee approval has been given 10th March 2010. - Trial with medicinal product

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

Details

• Lead Sponsor: University of Zurich

Criteria

Inclusion criteria:

• postmenopausal women with OAB

• prior cystoscopy to exclude a malignancy

• local or systemic hormone restitution therapy is allowed

• prior incontinence operation (if the operation dates back more than 12 months)

• german or french speaking patients and a given informed consent

Exclusion criteria:

• Intolerance against a substance or a compound

• participation in an other study 4 weeks prior to inclusion

• urinary tract infection

• drug abuse

• bladder affecting drugs like anticholinergics, diuretics, muscle relaxing medicaments and phytotherapeutics

• lactose intolerance

• diabetes mellitus.