Herbal Patch for Overactive Bladder

Phase 2

Completed

• Conditions: Overactive Bladder Syndrome
• Interventions: Drug: herbal patch; Drug: placebo patch

• Registration Number: NCT03532789
• Lead Sponsor: En Chu Kong Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-08
• Study Start: 2018-05-14
• Study First Submitted QC: 2018-05-21
• Study First Posted: 2018-05-22
• Status Verified: 2019-10
• Primary Completion: 2019-10-23
• Study Completion: 2019-10-23
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• urgency score of OABSS ≥ 2 or total score of OABSS ≥ 3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
herbal patch group	herbal patch	using herbal patch as an intervention
placebo patch group	placebo patch	using placebo patch as an intervention

Primary Outcome Measures

Name	Time	Method
OABSS	Change from Baseline OABSS at 2weeks	Overactive bladder symptom score, questionnaire

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

EnChuKong hospital; 🇨🇳 New Taipei City, Sanxia Dist, Taiwan