Herbal Patch for Overactive Bladder

NCT03532789 | Completed Phase 2 DMC

• 1 other identifier: ECKIRB1051203
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• OABSS

  Overactive bladder symptom score, questionnaire

  Change from Baseline OABSS at 2weeks

Secondary Outcomes (3)

• PPBC

  Change from Baseline PPBC at 2weeks

• USS

  Change from Baseline USS at 2weeks

• TCMBCQ

  Change from Baseline TCMBCQ at 2weeks

Study Arms (2)

herbal patch group

EXPERIMENTAL

using herbal patch as an intervention

Drug: herbal patch

placebo patch group

PLACEBO COMPARATOR

using placebo patch as an intervention

Drug: placebo patch

Interventions

herbal patch DRUG

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

Also known as: OAB patch

herbal patch group

placebo patch DRUG

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

Also known as: control patch

placebo patch group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• urgency score of OABSS ≥ 2 or total score of OABSS ≥ 3

You may not qualify if:

• 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

Sponsors & Collaborators

• En Chu Kong Hospital: lead

Study Sites (1)

EnChuKong hospital

New Taipei City, Sanxia Dist, 237, Taiwan

Location

Study Officials

• LIH-LIAN CHEN, MD

  attending physician of department of Traditional Chinese medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician of department of Traditional Chinese medicine

Model Details: overactive bladder patients

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 22, 2018
• Study Start: May 14, 2018
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: information sharing after paper published
• Access Criteria: all in public, without any kind of review

Locations

TW (1)