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

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ClinicalTrials.gov Identifier: NCT02129816
Recruitment Status : Terminated
First Posted : May 2, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
PD Dr. med. Verena Geissbühler
Prof. pharm. Ursula von Mandach
Dr. med. David Scheiner
Dr. med. Matthias Werner
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Overactive Bladder Urge Urinary Incontinence Drug: Bryophyllum Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2014
Actual Primary Completion Date : April 20, 2016
Actual Study Completion Date : July 9, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129816


Locations
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Switzerland
Gynecologic Department, University Hospital Zurich
Zurich, Switzerland, 8091
Gynecology Department, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
PD Dr. med. Verena Geissbühler
Prof. pharm. Ursula von Mandach
Dr. med. David Scheiner
Dr. med. Matthias Werner

Publications of Results:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02129816     History of Changes
Other Study ID Numbers: BryoSoliP-2014
KEK 2012-0530 (Zurich) ( Registry Identifier: Ethics committee Zurich )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by University of Zurich:
Female
Postmenopause

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents