Clinical trial NCT03532789: Herbal Patch for Overactive Bladder
Official title: Clinical Evaluation of Herbal Patch for Overactive Bladder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Overactive Bladder Syndrome
Lead sponsor: En Chu Kong Hospital
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: overactive bladder patients
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: OABSS
timeFrame: Change from Baseline OABSS at 2weeks
Secondary outcomes:
measure: PPBC
timeFrame: Change from Baseline PPBC at 2weeks
measure: USS
timeFrame: Change from Baseline USS at 2weeks
measure: TCMBCQ
timeFrame: Change from Baseline TCMBCQ at 2weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: EnChuKong hospital
state: Sanxia Dist
Study officials:
affiliation: attending physician of department of Traditional Chinese medicine
name: LIH-LIAN CHEN, MD
role: PRINCIPAL_INVESTIGATOR
References: