Bryophyllum Versus Placebo for Overactive Bladder

Phase 2

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Bryophyllum pinnatum, Placebo in form of Lactose

• Registration Number: NCT01127126
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Study Start: 2010-12
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bryophyllum	Bryophyllum pinnatum, Placebo in form of Lactose	muscle relaxing substance
Placebo	Bryophyllum pinnatum, Placebo in form of Lactose	control group postmenopausal women suffering from overactive bladder

Primary Outcome Measures

Name	Time	Method
Reduction of micturition frequency/24h	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	micturition frequency measured with the micturition protocoll

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology; 🇨🇭 Zurich, Switzerland