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