Bryophyllum Versus Placebo for Overactive Bladder

University of Zurich (UZH)

Status and phase

Completed

Phase 2

Conditions

Overactive Bladder

Treatments

Drug: Bryophyllum pinnatum, Placebo in form of Lactose

Study type

Interventional

Funder types

Other

Identifiers

NCT01127126

2009-0075/4

Details and patient eligibility

About

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

Full description

In the therapeutic concept of the treatment of OAB, antimuscarinic drugs play a central role. Antimuscarinics are known to inhibit the contraction of detrusor muscle (smooth muscle cells) and block the muscarinic receptor (M2/M3) important for efferent nerve conduction. This conventional therapy for OAB can have important adverse effects, notably on the gastrointestinal tract with constipation, on the excretory glands in the sense of xerostomia/xerophthalmia, on the nerve cells of the brain inhibiting cognitive function and in the heart muscle cells accelerating the heart rate. Especially elderly people are affected by these undesirable effects. Because of changes in the receptor profile, the effect of antimuscarinics and improvement of symptoms might be lowered in elderly people and another substance with less side effects would be of great interest. No such adverse effects are reported for B. pinnatum. Until now, there are no data for its use in OAB. Efficacy and tolerability of B. pinnatum in the treatment of OAB are the major outcome measures of this clinical trial.

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. Recruitment time is planned from July 2010 to June 2011.
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 decision has been given.

Enrollment

22 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.