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Herbal Patch for Overactive Bladder

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ClinicalTrials.gov Identifier: NCT03532789
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
LIH-LIAN Chen, 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: herbal patch Drug: placebo patch Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: overactive bladder patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Herbal Patch for Overactive Bladder Patients
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: control patch




Primary Outcome Measures :
  1. OABSS [ Time Frame: Change from Baseline OABSS at 2weeks ]
    Overactive bladder symptom score, questionnaire


Secondary Outcome Measures :
  1. PPBC [ Time Frame: Change from Baseline PPBC at 2weeks ]
    Patient perception of bladder condition, questionnaire

  2. USS [ Time Frame: Change from Baseline USS at 2weeks ]
    Urgency Severity Scale, questionnaire

  3. TCMBCQ [ Time Frame: Change from Baseline TCMBCQ at 2weeks ]
    Traditional Chinese Medicine Body Constitution Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532789


Contacts
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Contact: LIH-LIAN CHEN, MD +886-26723456 ext 3605 d339104001@tmu.edu.tw

Locations
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Taiwan
EnChuKong hospital Recruiting
New Taipei City, Sanxia Dist, Taiwan, 237
Contact: LIH-LIAN CHEN    886-2-26723456 ext 3205    01384@km.eck.org.tw   
Sponsors and Collaborators
En Chu Kong Hospital
Investigators
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Principal Investigator: LIH-LIAN CHEN, MD attending physician of department of Traditional Chinese medicine

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Responsible Party: LIH-LIAN Chen, Attending physician of department of Traditional Chinese medicine, En Chu Kong Hospital
ClinicalTrials.gov Identifier: NCT03532789     History of Changes
Other Study ID Numbers: ECKIRB1051203
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: primary and secondary outcome of this study
Supporting Materials: Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: information sharing after paper published
Access Criteria: all in public, without any kind of review

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms