Bryophyllum Versus Placebo for Overactive Bladder

NCT ID: NCT01127126

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-01-31

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bryophyllum

muscle relaxing substance

Group Type: ACTIVE_COMPARATOR

Bryophyllum pinnatum, Placebo in form of Lactose

Intervention Type: DRUG

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.

Placebo

control group postmenopausal women suffering from overactive bladder

Group Type: PLACEBO_COMPARATOR

Bryophyllum pinnatum, Placebo in form of Lactose

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Bryophyllum pinnatum/Kalanchoe; Lactose/milk sugar

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

Department of Obstetrics and Gynecology

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 23218404 (View on PubMed)

Other Identifiers

2009-0075/4

Identifier Type: -

Identifier Source: org_study_id