Skip to main content
OpenTrials
Completed

NCT Number: NCT03532789

Herbal Patch for Overactive Bladder

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overactive Bladder Syndrome

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

EnChuKong hospital

New Taipei City, Sanxia Dist, 237, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

herbal patch

Drug

One patch with medicine should be applied to the skin every other day within two weeks

Other names: OAB patch

Placebo Patch

Drug

One patch without medicine should be applied to the skin every other day within two weeks

Other names: control patch

Primary outcomes

  1. OABSS

    Time frame: Change from Baseline OABSS at 2weeks

    Overactive bladder symptom score, questionnaire

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

En Chu Kong Hospital

Other

Registry information

Official study title

Clinical Evaluation of Herbal Patch for Overactive Bladder Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 22, 2018
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.