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NCT03063827
Effect of Botulinum Toxin A on Neurogenic Detrusor Overactivity in Chronic Spinal Cord Injured Patients - An Investigation of Sensory Receptor Expressionsbetween Responders and Non-responders
trial testing OnabotulinumtoxinA 200 UNT in Neurogenic Bladder in 36 participants. Completed in 1 December 2012.
1 December 2012
Quick facts
| Lead sponsor | Buddhist Tzu Chi General Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 36 |
| Start date | 1 January 2010 |
| Primary completion | 1 December 2012 |
| Estimated completion | 1 December 2012 |
Drugs / interventions tested
- OnabotulinumtoxinA 200 UNT — full drug profile →
- Urothelial sensory protein levels
Conditions studied
- Neurogenic Bladder — all drugs for Neurogenic Bladder →
Sponsor
Buddhist Tzu Chi General Hospital
Who can join
18 and older, any sex, with Neurogenic Bladder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Bladder capacity
Time frame: from baseline to 6 months after treatment
The maximal cystometric or functional bladder capacity
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03063827
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Other Buddhist Tzu Chi General Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03063827 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Buddhist Tzu Chi General Hospital
- Last refreshed: 9 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03063827.
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