Herbal Patch for Overactive Bladder

En Chu Kong Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Overactive Bladder Syndrome

Treatments: Drug: herbal patch; Drug: placebo patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03532789

ECKIRB1051203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups, including a placebo group

herbal patch group

Experimental group

Description:

using herbal patch as an intervention

Treatment:

Drug: herbal patch

placebo patch group

Placebo Comparator group

Description:

using placebo patch as an intervention

Treatment:

Drug: placebo patch