Overactive BladderPhase 2/3BryoSoliPNCT02129816
Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder
A Phase 2/3 study testing Bryophyllum in people with Overactive Bladder and Urge Urinary Incontinence, run by University of Zurich at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urge Urinary Incontinence
- What is being tested?
- Bryophyllum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 2 sitesSwitzerland
- Study dates
- May 2014to 9 Jul 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Gynecologic Department, University Hospital Zurich
Zurich, 8091
Gynecology Department, University Hospital Zurich
Zurich, 8091
About this study
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
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).
Read the 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.
- Conditions
- Overactive Bladder, Urge Urinary Incontinence
- Being tested
- Bryophyllum
- Keywords
- Female, Postmenopause
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BryophyllumDrug
Also called dried leave press juice, provided by Weleda AG, Arlesheim, Switzerland
| Study group | Role | What they receive |
|---|---|---|
| Bryophyllum | Active comparator | 50% in 350mg Lactose, 2-2-2 Receives: Drug: Bryophyllum |
| Placebo | Placebo comparator | Lactose 350mg, 2-2-2 Receives: Drug: Bryophyllum |
| Solifenacin | Experimental | 10mg in 350mg Lactose, 2-2-2 Receives: Drug: Bryophyllum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the micturition frequency
assessment of the voiding frequency in the 3-day bladder at visit 2,3,4,5,6
Measured: 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
assessment with quality of life and symptom burden questionnaires at visit 2,3,4,5,6 (questionnaires ICIQ-OAB and KHQ)
Measured: participants will be followed for the duration of the study, an expected average of 35 weeks
Voiding diary parameters
3-day bladder diary returned at visit 2,3,4,5,6
Measured: participants will be followed for the duration of the study, an expected average of 35 weeks
Assessments of the patient's compliance
drug intake protocol and counting of the returned tablets
Measured: participants will be followed for the duration of the study, an expected average of 35 weeks
Assessment of AE/SAE
AE/SAE protocol
Measured: participants will be followed for the duration of the study, an expected average of 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2014
- Primary completion20 Apr 2016
- Study completion9 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- PD Dr. med. Verena Geissbühler, Prof. pharm. Ursula von Mandach, Dr. med. David Scheiner, Dr. med. Matthias Werner
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129816
- Sponsor's protocol ID
- BryoSoliP-2014
- Other IDs
- KEK 2012-0530 (Zurich)
- Acronym
- BryoSoliP
- Status last verified
- Oct 2017
- First submitted
- 25 Apr 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23218404
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02129816
- Acronym / sponsor ID
- BryoSoliP / BryoSoliP-2014
- Conditions
- Overactive Bladder, Urge Urinary Incontinence
- Keywords
- Female, Postmenopause
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- PD Dr. med. Verena Geissbühler, Prof. pharm. Ursula von Mandach, Dr. med. David Scheiner, Dr. med. Matthias Werner
- Study start
- May 2014
- Primary completion
- 20 Apr 2016 (actual)
- Study completion
- 9 Jul 2017 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bryophyllum | Active comparator | Drug: Bryophyllum50% in 350mg Lactose, 2-2-2 |
| Placebo | Placebo comparator | Drug: BryophyllumLactose 350mg, 2-2-2 |
| Solifenacin | Experimental | Drug: Bryophyllum10mg in 350mg Lactose, 2-2-2 |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BryophyllumAlso: dried leave press juice, provided by Weleda AG, Arlesheim, Switzerland | Drug | Bryophyllum, Placebo, Solifenacin |
Primary outcome
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
4 secondary outcomes
Changes in quality of life parameters
Time frame: 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
Assessments of the patient's compliance
Time frame: 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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Results publication: PubMed 23218404Betschart 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.
Related trials for Overactive Bladder
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bryophyllum in people with Overactive Bladder and Urge Urinary Incontinence, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the micturition frequency (time frame: participants will be followed for the duration of the study, an expected average of 35 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.