Herbal Patch for Overactive Bladder

Clinical Evaluation of Herbal Patch for Overactive Bladder Patients

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Drug: herbal patch; Drug: placebo patch

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Sanxia Dist
    • New Taipei City, Sanxia Dist, Taiwan, 237
      • EnChuKong hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: En Chu Kong Hospital
• Investigators: Principal Investigator: LIH-LIAN CHEN, MD, attending physician of department of Traditional Chinese medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): October 23, 2019
• Study Completion (Actual): October 23, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: ECKIRB1051203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: primary and secondary outcome of this study
• IPD Sharing Time Frame: information sharing after paper published
• IPD Sharing Access Criteria: all in public, without any kind of review
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No