Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder (BryoSoliP)

October 24, 2017 updated by: University of Zurich

Treatment of Patients With Overactive Bladder With Bryophyllum Pinnatum Versus Solifenacinsuccinat Versus Placebo: Multicenter, Prospective, Double-blind Randomized, Placebo-controlled Cross-over Study, Phase III Trial

Overactive bladder (OAB) is an enigmatic condition that is treated symptomatically with anticholinergic drugs (gold standard 2013). In a clinical pilot study was found to be a trend for a higher reduction of the micturition frequency in the Bryophyllum pinnatum group - treated with chewing tablets containing 50% of dried BP leaf press juice - than in the placebo group (n=20, p=0.064) Hypothesis: To test the superior effectivity of Bryophyllum versus Placebo in the treatment of OAB with the needed number (Purpose 1) and to assess in an experimental arm the side effects of BP in comparison to the standard drug (Vesicare) in a clincial trial (Purpose 2).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  • In a US nation-wide survey, lower urinary tract symptoms are one of the strongest predictors that patients will seek complementary and alternative medicine (CAM) care. In comparison to general gynecological patients, urogynecological patients are particularly prone to seek help in CAM. Moreover out of the different CAM options, herbal medication is one of the most preferred treatments. However, the effectiveness of CAM regarding OAB has not yet been adequately and objectively evaluated. Therefore, it is timely and essential to elucidate the mode of action as well as to prove efficacy of herbal treatments by a translational approach including comprehensive in vitro experimentation and randomized controlled clinical trials. Bryophyllum pinnatum and specially the flavonoid components have shown a muscle relaxing effect on porcine bladder strips.
  • Study Design: Multicenter, prospective, double-blind randomized, placebo-controlled cross-over study, phase III to test the superiority of Bryophyllum pinnatum (BP) over placebo in the treatment of overactive bladder.
  • In this cross-over trial a total of 30 patients is needed to proof the superiority of BP over placebo (5 randomization blocs, each 6 patients). Each patient gets each of the three study drugs (BP, Solifenacin, Placebo) in a double-blind randomization. The number of patients was calculated in a post-hoc analysis based on the primary endpoint of a previous study (reduction of micturition rates/24hours; 9.5 (SD2.2) before and 7.8 (SD1.2) after Bryophyllum versus 9.3 (SD1.8) before and 9.1(SD1.6) after placebo), under the assumption of a normal data distribution and a power of 80% a patient number of 2x20. Plus 10% for non-parametric tests in the case of a non-normal distribution (Wilcoxon) were added, what generated a number of 2x22 patients.
  • In order to facilitate an equality in the randomization, the investigator choose a cross-over design. Due to the length of the study time, the drop-out rate was risen from 10 to 20% what yielded under the assumption of a equal block randomization the number of 30 patients. Additionally, an explorative arm containing the standard medication Vesicare was inserted, as this is of great clinical interest. For this explorative comparative arm are no existing data that would allow to do a power calculation.
  • This follow-up study will give a compelling answer on the efficacy or non-efficacy of BP as well as the safety of BP in respect to placebo and possible answers of its position regarding the standard medication Vesicare.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Gynecologic Department, University Hospital Zurich
      • Zurich, Switzerland, 8091
        • Gynecology Department, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • OAB (>8 micturitions/24 hours, associated with urge symptoms)
  • postmenopausal women
  • cystoscopy to exclude a bladder carcinoma or carcinoma in situ
  • written and oral informed consent

Exclusion Criteria:

  • urinary tract infection in an intermittent catheter asservated sample (>1000 bacterias/ml)
  • intake of bladder affecting drugs like anticholinergics, diuretics, muscle relaxing medications and phytotherapeutics in the last three months
  • neurological conditions such as stroke, multiple sclerosis, spinal cord injury or Parkinsons's disease
  • postvoid residual volume ≥100 ml
  • lactose intolerance
  • contraindication for Solifenacin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bryophyllum
50% in 350mg Lactose, 2-2-2
Drug: Bryophyllum
Other Names:
  • dried leave press juice
  • provided by Weleda AG, Arlesheim, Switzerland
Placebo Comparator: Placebo
Lactose 350mg, 2-2-2
Drug: Bryophyllum
Other Names:
  • dried leave press juice
  • provided by Weleda AG, Arlesheim, Switzerland
Experimental: Solifenacin
10mg in 350mg Lactose, 2-2-2
Drug: Bryophyllum
Other Names:
  • dried leave press juice
  • provided by Weleda AG, Arlesheim, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the micturition frequency
Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks
assessment of the voiding frequency in the 3-day bladder at visit 2,3,4,5,6
participants will be followed for the duration of the study, an expected average of 35 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quality of life parameters
Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks
assessment with quality of life and symptom burden questionnaires at visit 2,3,4,5,6 (questionnaires ICIQ-OAB and KHQ)
participants will be followed for the duration of the study, an expected average of 35 weeks
Voiding diary parameters
Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks
3-day bladder diary returned at visit 2,3,4,5,6
participants will be followed for the duration of the study, an expected average of 35 weeks
Assessments of the patient's compliance
Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks
drug intake protocol and counting of the returned tablets
participants will be followed for the duration of the study, an expected average of 35 weeks
Assessment of AE/SAE
Time Frame: participants will be followed for the duration of the study, an expected average of 35 weeks
AE/SAE protocol
participants will be followed for the duration of the study, an expected average of 35 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

PD Dr. med. Verena Geissbühler
Prof. pharm. Ursula von Mandach
Dr. med. David Scheiner
Dr. med. Matthias Werner

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

April 20, 2016

Study Completion (Actual)

July 9, 2017

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BryoSoliP-2014
  • KEK 2012-0530 (Zurich) (Registry Identifier: Ethics committee Zurich)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overactive Bladder

Clinical Trials on Bryophyllum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe