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Effect of Botulinum Toxin A on Neurogenic Detrusor Overactivity in Chronic Spinal Cord Injured Patients

NCT03063827 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2017-03-13

No results posted yet for this study

Summary

This study investigated the changes in urothelial dysfunction and sensory protein expression in the bladder urothelium with time after onabotulinumtoxin injection in spinal cord injured (SCI) patients. The investigators planned to enroll 30 chronic SCI patient with neurogenic detrusor overactivity and urinary incontinence were treated with a single injection of 200 U onabotulinumtoxinA at the detrusor. Video urodynamic studies and bladder mucosal biopsies were performed at baseline, 3 months, and 6 months after treatment. Bladder tissues will be investigated for urothelial barrier and inflammation proteins as well as sensory proteins by Western blotting, between SCI patients and 10 controls, as well as successful and failed treatment groups. This study will explore the therapeutic efficacy of a single injection of 200 U onabotulinumtoxinA on neurogenic detrusor overactivity and the changes of urothelial sensory proteins in SCI patients with successful and failed treatment outcome.

Conditions

  • Neurogenic Bladder

Interventions

DRUG

OnabotulinumtoxinA 200 UNT

Patient in the treatment arm received a single injection of onabotulinumtoxinA 200 UNT to the detrusor muscle at 20 sites of the bladder body.

DIAGNOSTIC_TEST

Urothelial sensory protein levels

Bladder tissues were investigated for urothelial barrier and inflammation proteins as well as urothelial sensory protein levels by Western blotting, between SCI patients and 10 controls, as well as successful and failed treatment groups.

Sponsors & Collaborators

  • Buddhist Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Hann-Chorng Kuo, M.D. · Department of Urology, Buddhist Tzu Chi General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-12-31
Completion
2012-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063827 on ClinicalTrials.gov