Bryophyllum Versus Placebo for Overactive Bladder

Overactive Bladder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127126
• Other study ID #: 2009-0075/4
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2010
• Last updated: January 18, 2012
• Start date: December 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Department of Obstetrics and Gynecology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes