Overactive Bladder SyndromePhase 2/3NCT03532789
Herbal Patch for Overactive Bladder
A Phase 2/3 study testing herbal patch in people with Overactive Bladder Syndrome, run by En Chu Kong Hospital at 1 site in Taiwan.
Trial summary
Overactive bladder is a clinical syndrome characterized by frequency, with or without urge incontinence, urgency, and nocturia, which affect patients' sleeping quality and rehabilitation program progressing. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- herbal patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 May 2018to 23 Oct 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- urgency score of OABSS ≥ 2 or total score of OABSS ≥ 3
Who cannot join
- suffering from acute urinary tract infection
- recurrent urinary tract infection ≥ 5 times in the last year
- Hematuria or bladder stone disease
- using foley catheter
- Pregnant or breastfeeding women
- Spinal cord injury patients
- Mental illness or substance abuse
- taking medicine for the treatment of overactive bladder within one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Herbal Patch for Overactive Bladder Patients
Overactive bladder is a clinical syndrome characterized by frequency, with or without urge incontinence, urgency, and nocturia, which affect patients' sleeping quality and rehabilitation program progressing. Current treatments include behavioral therapy (eg, life style adjustment, bladder training, pelvic floor muscle therapy) and medication. Antimuscarinic agents is the most common medications prescribed for OAB, but patients often have side effects like dry mouth and constipation. And there were plenty of herbal medicine which are beneficial to urine frequency and voiding dysfunction in ancient Chinese medicine books and records. In human trial, 62 Subjects diagnosed as overactive bladder will be enrolled and treated with Cinnamon patch. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.
Read the detailed description
Overactive bladder is a clinical syndrome characterized by frequency, with or without urge incontinence, urgency, and nocturia, which affect patients' sleeping quality and rehabilitation program progressing. Current treatments include behavioral therapy (eg, life style adjustment, bladder training, pelvic floor muscle therapy) and medication. Antimuscarinic agents is the most common medications prescribed for OAB, but patients often have side effects like dry mouth and constipation. And there were plenty of herbal medicine which are beneficial to urine frequency and voiding dysfunction in ancient Chinese medicine books and records. In human trial, 62 Subjects diagnosed as overactive bladder will be enrolled and treated with Cinnamon patch. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.
The 1st year project: (1) Expect to enroll 62 clinical subjects of OAB. (2) Evaluate subjects 'symptom and proceed patch treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis.
The 2nd year project: (1) Completing enrollment of 62 clinical subjects of OAB. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- herbal patch, placebo patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herbal patchDrug
Also called OAB patch
One patch with medicine should be applied to the skin every other day within two weeks
placebo patchDrug
Also called control patch
One patch without medicine should be applied to the skin every other day within two weeks
| Study group | Role | What they receive |
|---|---|---|
| herbal patch group | Experimental | using herbal patch as an intervention Receives: Drug: herbal patch |
| placebo patch group | Placebo comparator | using placebo patch as an intervention Receives: Drug: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
OABSS
Overactive bladder symptom score, questionnaire
Measured: Change from Baseline OABSS at 2weeks
Secondary outcomes (3)
PPBC
Patient perception of bladder condition, questionnaire
Measured: Change from Baseline PPBC at 2weeks
USS
Urgency Severity Scale, questionnaire
Measured: Change from Baseline USS at 2weeks
TCMBCQ
Traditional Chinese Medicine Body Constitution Questionnaire
Measured: Change from Baseline TCMBCQ at 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start14 May 2018
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- overactive bladder patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- En Chu Kong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIH-LIAN Chen, En Chu Kong Hospital
- Investigators
- LIH-LIAN CHEN, MD, Principal investigator, attending physician of department of Traditional Chinese medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532789
- Sponsor's protocol ID
- ECKIRB1051203
- Status last verified
- Oct 2019
- First submitted
- 8 May 2018
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: primary and secondary outcome of this study
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Herbal Patch for Overactive Bladder Patients
- ClinicalTrials.gov ID
- NCT03532789
- Acronym / sponsor ID
- ECKIRB1051203
- Conditions
- Overactive Bladder Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- En Chu Kong HospitalUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 22 May 2018 (actual)
- 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 is a clinical syndrome characterized by frequency, with or without urge incontinence, urgency, and nocturia, which affect patients' sleeping quality and rehabilitation program progressing. Current treatments include behavioral therapy (eg, life style adjustment, bladder training, pelvic floor muscle therapy) and medication. Antimuscarinic agents is the most common medications prescribed for OAB, but patients often have side effects like dry mouth and constipation. And there were plenty of herbal medicine which are beneficial to urine frequency and voiding dysfunction in ancient Chinese medicine books and records. In human trial, 62 Subjects diagnosed as overactive bladder will be enrolled and treated with Cinnamon patch. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.
Detailed description
Overactive bladder is a clinical syndrome characterized by frequency, with or without urge incontinence, urgency, and nocturia, which affect patients' sleeping quality and rehabilitation program progressing. Current treatments include behavioral therapy (eg, life style adjustment, bladder training, pelvic floor muscle therapy) and medication. Antimuscarinic agents is the most common medications prescribed for OAB, but patients often have side effects like dry mouth and constipation. And there were plenty of herbal medicine which are beneficial to urine frequency and voiding dysfunction in ancient Chinese medicine books and records. In human trial, 62 Subjects diagnosed as overactive bladder will be enrolled and treated with Cinnamon patch. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.
The 1st year project: (1) Expect to enroll 62 clinical subjects of OAB. (2) Evaluate subjects 'symptom and proceed patch treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis.
The 2nd year project: (1) Completing enrollment of 62 clinical subjects of OAB. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- overactive bladder patients
| Arm | Type | Receives |
|---|---|---|
| herbal patch group | Experimental | Drug: herbal patchusing herbal patch as an intervention |
| placebo patch group | Placebo comparator | Drug: placebo patchusing placebo patch as an intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- urgency score of OABSS ≥ 2 or total score of OABSS ≥ 3
Key exclusion criteria (8 listed)
- suffering from acute urinary tract infection
- recurrent urinary tract infection ≥ 5 times in the last year
- Hematuria or bladder stone disease
- using foley catheter
- Pregnant or breastfeeding women
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 |
|---|---|---|
| herbal patchAlso: OAB patchOne patch with medicine should be applied to the skin every other day within two weeks | Drug | herbal patch group |
| placebo patchAlso: control patchOne patch without medicine should be applied to the skin every other day within two weeks | Drug | placebo patch group |
Primary outcome
OABSS
Time frame: Change from Baseline OABSS at 2weeks
Overactive bladder symptom score, questionnaire
3 secondary outcomes
PPBC
Time frame: Change from Baseline PPBC at 2weeks
USS
Time frame: Change from Baseline USS at 2weeks
TCMBCQ
Time frame: Change from Baseline TCMBCQ at 2weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Individual participant dataSharing planned: Yes. primary and secondary outcome of this study
Related trials for Overactive Bladder Syndrome
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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Tensi+ for Treating Overactive Bladder
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Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
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Improving Overactive Bladder Treatment Access and Adherence
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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.
LIH-LIAN CHEN, MD principal investigator
attending physician of department of Traditional Chinese medicine
1 site 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 herbal patch in people with Overactive Bladder Syndrome, run by En Chu Kong Hospital at 1 site in Taiwan.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OABSS (time frame: Change from Baseline OABSS at 2weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2019.