NCT02129816

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2014

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

April 25, 2014

Last Update Submit

October 24, 2017

Conditions

Overactive BladderUrge Urinary Incontinence

Keywords

FemalePostmenopause

Outcome Measures

Primary Outcomes (1)

  • Change of the micturition frequency

    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 Outcomes (4)

  • Changes in quality of life parameters

    participants will be followed for the duration of the study, an expected average of 35 weeks

  • Voiding diary parameters

    participants will be followed for the duration of the study, an expected average of 35 weeks

  • Assessments of the patient's compliance

    participants will be followed for the duration of the study, an expected average of 35 weeks

  • Assessment of AE/SAE

    participants will be followed for the duration of the study, an expected average of 35 weeks

Study Arms (3)

Bryophyllum

ACTIVE COMPARATOR

50% in 350mg Lactose, 2-2-2

Drug: Bryophyllum

Placebo

PLACEBO COMPARATOR

Lactose 350mg, 2-2-2

Drug: Bryophyllum

Solifenacin

EXPERIMENTAL

10mg in 350mg Lactose, 2-2-2

Drug: Bryophyllum

Interventions

BryophyllumDRUG
Also known as: dried leave press juice, provided by Weleda AG, Arlesheim, Switzerland
BryophyllumPlaceboSolifenacin

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gynecologic Department, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Gynecology Department, University Hospital Zurich

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: 23218404RESULT

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Study Design

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

Study Record Dates

First Submitted

April 25, 2014

First Posted

May 2, 2014

Study Start

May 1, 2014

Primary Completion

April 20, 2016

Study Completion

July 9, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

CH(2)