Overactive Bladder Syndrome
Conditions
Brief 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. 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.
Interventions
DRUGherbal patch
One patch with medicine should be applied to the skin every other day within two weeks
DRUGplacebo patch
One patch without medicine should be applied to the skin every other day within two weeks
Sponsors
En Chu Kong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
overactive bladder patients
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OABSS | Change from Baseline OABSS at 2weeks | Overactive bladder symptom score, questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PPBC | Change from Baseline PPBC at 2weeks | Patient perception of bladder condition, questionnaire |
| USS | Change from Baseline USS at 2weeks | Urgency Severity Scale, questionnaire |
| TCMBCQ | Change from Baseline TCMBCQ at 2weeks | Traditional Chinese Medicine Body Constitution Questionnaire |
Countries
Taiwan
Outcome results
None listed