Bryophyllum Versus Placebo for Overactive Bladder

NCT01127126 | Completed Phase 2 DMC

• 1 other identifier: 2009-0075/4
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Bryophyllum

ACTIVE COMPARATOR

muscle relaxing substance

Drug: Bryophyllum pinnatum, Placebo in form of Lactose

Placebo

PLACEBO COMPARATOR

control group postmenopausal women suffering from overactive bladder

Drug: Bryophyllum pinnatum, Placebo in form of Lactose

Interventions

Bryophyllum pinnatum, Placebo in form of Lactose 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.

Also known as: Bryophyllum pinnatum/Kalanchoe, Lactose/milk sugar

Bryophyllum; Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intolerance against a substance or a compound
• urinary tract infection
• drug abuse
• bladder affecting drugs like anticholinergics, diuretics, muscle relaxing medicaments and phytotherapeutics
• lactose intolerance
• diabetes mellitus.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Obstetrics and Gynecology

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 23218404 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 20, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

CH (1)