Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients
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Purpose
To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI) patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injuries |
Drug: Botulinum toxin A |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients - Clinical Effects and Investigating Mechanism of Action |
- Net change of the quality of life measurement questionnaires [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
Efficacy:
Net change of the quality of life measurement questionnaires (IIQ-7 and UDI-6) from baseline to 24 months
Safety:
Systemic adverse events
- Net change of the glomerular filtration rate (GFR) [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
Efficacy:
Net change of the glomerular filtration rate (GFR) from baseline to 24 months
Safety:
Systemic adverse events
- Net change of the cystometric bladder capacity [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
Efficacy:
Efficacy measured the net change of the cystometric bladder capacity (CBC) from baseline to 24 months
Safety:
Systemic adverse events
- Net change of the bladder compliance [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
Efficacy:
Efficacy measured the net change of the bladder compliance from baseline to 24 months
Safety:
Systemic adverse events
- Net change of the detrusor pressure during reflex voiding [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
Efficacy:
Efficacy measured the net change of the detrusor pressure during reflex voiding from baseline to 24 months
Safety:
Systemic adverse events
- Net change of the end-filling pressure [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
Efficacy:
Efficacy measured the net change of the end-filling pressure from baseline to 24 months
Safety:
Systemic adverse events
- Net change of the detrusor leak-point pressure [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
Efficacy:
Efficacy measured the net change of the detrusor leak-point pressure from baseline to 24 months
Safety:
Systemic adverse events
- Net change of the postvoid residual volume [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
Efficacy:
Efficacy measured the net change of the postvoid residual volume from baseline to 24 months
Safety:
Systemic adverse events
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Botulinum toxin A
BoNT-A (BOTOX 300U)
|
Drug: Botulinum toxin A
BoNT-A (BOTOX 300U)
Other Name: BoNT-A (BOTOX 300U)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults with age of 19 years old or above
- Patients with chronic suprasacral cord SCI will be enrolled.
- Patients will be proven having NDO by videourodynamic study during the screening period.
- They also receive 99mTc-DTPA renal scanning for glomerular filtration rate (GFR) at baseline.
- Patients with NDO induced urinary incontinence who have adequate hand function or have a care-giver available for clean intermittent catheterization (CIC), and the baseline total GFR of less than 80 ml/min are main inclusion criteria
Exclusion Criteria:
- Patients with detrusor underactivity and large bladder compliance, patients proven to have intrinsic sphincteric deficiency
- Patients who have hypersensitivity to botulinum toxin A (BTX-A) or constituent ingredients of BTX-A.
Contacts and Locations| Contact: Hann-Chorng Kuo, M.D. | 886-3-8561825 ext 2113 | hck@tzuchi.com.tw |
| Contact: Dong-Ling Tang, Miss | 886-3-8561825 ext 2117 | don_lin86@yahoo.com.tw |
| Taiwan | |
| Buddhist Tzu Chi General Hospital | Recruiting |
| Hualien, Taiwan, 970 | |
| Contact: Hann-Chorng Kuo, M.D. 886-3-8561825 ext 2113 hck@tzuchi.com.tw | |
| Contact: Dong-Ling Tang, Miss 886-3-8561825 ext 2117 don_lin86@yahoo.com.tw | |
| Principal Investigator: | Hann-Chorng Kuo, M.D. | Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University |
More Information
Publications:
| Responsible Party: | Hann-Chorng Kuo, Director of Urology, Buddhist Tzu Chi General Hospital |
| ClinicalTrials.gov Identifier: | NCT01682603 History of Changes |
| Other Study ID Numbers: | TCGHUROL005 |
| Study First Received: | September 7, 2012 |
| Last Updated: | November 20, 2012 |
| Health Authority: | Taiwan: Department of Health Taiwan: Research Ethics Committee |
Keywords provided by Buddhist Tzu Chi General Hospital:
|
Nerve growth factor P2X3 receptor TRPV-1 receptor Bladder function |
Glomerular filtration rate Detrusor overactivity Spinal cord injury |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Botulinum Toxins, Type A Botulinum Toxins |
Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013