Bryophyllum Versus Placebo for Overactive Bladder

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)

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Bryophyllum pinnatum, Placebo in form of Lactose

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Department of Obstetrics and gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bryophyllum; muscle relaxing substance	Drug: Bryophyllum pinnatum, Placebo in form of Lactose; 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.; Other Names: Bryophyllum pinnatum/Kalanchoe; Lactose/milk sugar
Placebo Comparator: Placebo; control group postmenopausal women suffering from overactive bladder	Drug: Bryophyllum pinnatum, Placebo in form of Lactose; 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.; Other Names: Bryophyllum pinnatum/Kalanchoe; 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

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• Betschart C, von Mandach U, Seifert B, Scheiner D, Perucchini D, Fink D, Geissbuhler V. Randomized, double-blind placebo-controlled trial with Bryophyllum pinnatum versus placebo for the treatment of overactive bladder in postmenopausal women. Phytomedicine. 2013 Feb 15;20(3-4):351-8. doi: 10.1016/j.phymed.2012.10.007. Epub 2012 Dec 4.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (Estimate): May 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 19, 2012
• Last Update Submitted That Met QC Criteria: January 18, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 2009-0075/4