Bryophyllum Versus Placebo for Overactive Bladder

Study Overview
=================
Brief 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

Detailed 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.

Official Title
-----------------
Treatment of the Overactive Bladder in Postmenopausal Women With Bryophyllum Pinnatum Versus Placebo (a Multicenter, Prospective, Double-blind Randomised, Placebo-controlled Clinical Pilot Study, Phase II Drug Study)

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Bryophyllum pinnatum, Placebo in form of Lactose


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bryophyllum<br>muscle relaxing substance | Drug: Bryophyllum pinnatum, Placebo in form of Lactose<br>* Comparison Bryophyllum (2100mg/d) against Placebo (2100mg/d) regarding effectivity and safety. Bryophyllum and Placebo are both administered for 8 weeks. Bryophyllum and Placebo are both given in form of capsules, 350mg per capsule, 2-2-2/d.<br>* Other names: Lactose/milk sugar;|
| Placebo Comparator: Placebo<br>control group postmenopausal women suffering from overactive bladder | Drug: Bryophyllum pinnatum, Placebo in form of Lactose<br>* Comparison Bryophyllum (2100mg/d) against Placebo (2100mg/d) regarding effectivity and safety. Bryophyllum and Placebo are both administered for 8 weeks. Bryophyllum and Placebo are both given in form of capsules, 350mg per capsule, 2-2-2/d.<br>* Other names: Lactose/milk sugar;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of micturition frequency/24h | micturition frequency measured with the micturition protocoll | micturition protocol three days before baseline visit and follow-up control 2 and 8 weeks after medication intake and 6 weeks after the completed medication period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | quality of life is measured by the King's Health Questionnaire and the ICIQ-OAB, a specific questionnaire for OAB | before baseline control, at follow-up control 8 weeks after begin of medication intake and 6 weeks after end of medication intake | 
| safety of Bryophyllum intake and adverse events | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | during medication intake at 2 weeks and 8 weeks after start of medicaton intake, measured by a personal adverse event protocol |