Herbal Patch for Overactive Bladder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Herbal Patch for Overactive Bladder Patients

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Drug: herbal patch
* Drug: placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: urgency score of OABSS ≥ 2 or total score of OABSS ≥ 3 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: overactive bladder patients
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: herbal patch group<br>using herbal patch as an intervention | Drug: herbal patch<br>* One patch with medicine should be applied to the skin every other day within two weeks<br>* Other names: OAB patch;|
| Placebo Comparator: placebo patch group<br>using placebo patch as an intervention | Drug: placebo patch<br>* One patch without medicine should be applied to the skin every other day within two weeks<br>* Other names: control patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OABSS | Overactive bladder symptom score, questionnaire | Change from Baseline OABSS at 2weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPBC | Patient perception of bladder condition, questionnaire | Change from Baseline PPBC at 2weeks | 
| USS | Urgency Severity Scale, questionnaire | Change from Baseline USS at 2weeks | 
| TCMBCQ | Traditional Chinese Medicine Body Constitution Questionnaire | Change from Baseline TCMBCQ at 2weeks |