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Herbal Patch for Overactive Bladder

Primary Purpose

Overactive Bladder Syndrome

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
herbal patch
placebo patch
Sponsored by
En Chu Kong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • EnChuKong hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

herbal patch group

placebo patch group

Arm Description

using herbal patch as an intervention

using placebo patch as an intervention

Outcomes

Primary Outcome Measures

OABSS
Overactive bladder symptom score, questionnaire

Secondary Outcome Measures

PPBC
Patient perception of bladder condition, questionnaire
USS
Urgency Severity Scale, questionnaire
TCMBCQ
Traditional Chinese Medicine Body Constitution Questionnaire

Full Information

First Posted
May 8, 2018
Last Updated
October 23, 2019
Sponsor
En Chu Kong Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03532789
Brief Title
Herbal Patch for Overactive Bladder
Official Title
Clinical Evaluation of Herbal Patch for Overactive Bladder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
October 23, 2019 (Actual)
Study Completion Date
October 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
En Chu Kong Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
overactive bladder patients
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
herbal patch group
Arm Type
Experimental
Arm Description
using herbal patch as an intervention
Arm Title
placebo patch group
Arm Type
Placebo Comparator
Arm Description
using placebo patch as an intervention
Intervention Type
Drug
Intervention Name(s)
herbal patch
Other Intervention Name(s)
OAB patch
Intervention Description
One patch with medicine should be applied to the skin every other day within two weeks
Intervention Type
Drug
Intervention Name(s)
placebo patch
Other Intervention Name(s)
control patch
Intervention Description
One patch without medicine should be applied to the skin every other day within two weeks
Primary Outcome Measure Information:
Title
OABSS
Description
Overactive bladder symptom score, questionnaire
Time Frame
Change from Baseline OABSS at 2weeks
Secondary Outcome Measure Information:
Title
PPBC
Description
Patient perception of bladder condition, questionnaire
Time Frame
Change from Baseline PPBC at 2weeks
Title
USS
Description
Urgency Severity Scale, questionnaire
Time Frame
Change from Baseline USS at 2weeks
Title
TCMBCQ
Description
Traditional Chinese Medicine Body Constitution Questionnaire
Time Frame
Change from Baseline TCMBCQ at 2weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LIH-LIAN CHEN, MD
Organizational Affiliation
attending physician of department of Traditional Chinese medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
EnChuKong hospital
City
New Taipei City
State/Province
Sanxia Dist
ZIP/Postal Code
237
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Herbal Patch for Overactive Bladder

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