Herbal Patch for Overactive Bladder

Overview

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 Title of Study: “Clinical Evaluation of Herbal Patch for Overactive Bladder Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 23, 2019

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

  • Drug: herbal patch
    • One patch with medicine should be applied to the skin every other day within two weeks
  • Drug: placebo patch
    • One patch without medicine should be applied to the skin every other day within two weeks

Arms, Groups and Cohorts

  • Experimental: herbal patch group
    • using herbal patch as an intervention
  • Placebo Comparator: placebo patch group
    • using placebo patch as an intervention

Clinical Trial Outcome Measures

Primary Measures

  • OABSS
    • Time Frame: Change from Baseline OABSS at 2weeks
    • Overactive bladder symptom score, questionnaire

Secondary Measures

  • PPBC
    • Time Frame: Change from Baseline PPBC at 2weeks
    • Patient perception of bladder condition, questionnaire
  • USS
    • Time Frame: Change from Baseline USS at 2weeks
    • Urgency Severity Scale, questionnaire
  • TCMBCQ
    • Time Frame: Change from Baseline TCMBCQ at 2weeks
    • Traditional Chinese Medicine Body Constitution Questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • En Chu Kong Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: LIH-LIAN Chen, Attending physician of department of Traditional Chinese medicine – En Chu Kong Hospital
  • Overall Official(s)
    • LIH-LIAN CHEN, MD, Principal Investigator, attending physician of department of Traditional Chinese medicine

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