Herbal Patch for Overactive Bladder

Overactive Bladder Syndrome Clinical Trial

Official title:

Clinical Evaluation of Herbal Patch for Overactive Bladder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532789
• Other study ID #: ECKIRB1051203
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 14, 2018
• Est. completion date: October 23, 2019

Study information

• Verified date: October 2019
• Source: En Chu Kong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 23, 2019
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Taiwan	EnChuKong hospital	New Taipei City	Sanxia Dist

Sponsors (1)

Lead Sponsor	Collaborator
En Chu Kong Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OABSS	Overactive bladder symptom score, questionnaire	Change from Baseline OABSS at 2weeks
Secondary	PPBC	Patient perception of bladder condition, questionnaire	Change from Baseline PPBC at 2weeks
Secondary	USS	Urgency Severity Scale, questionnaire	Change from Baseline USS at 2weeks
Secondary	TCMBCQ	Traditional Chinese Medicine Body Constitution Questionnaire	Change from Baseline TCMBCQ at 2weeks