Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients

This study is currently recruiting participants.
Verified October 2013 by Buddhist Tzu Chi General Hospital
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01682603
First received: September 7, 2012
Last updated: October 24, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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)

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  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682603

Contacts
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

Locations
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   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Hann-Chorng Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
  More Information

Publications:
Cruz F, Avelino A, Cruz C, et al. Sensory fibers immunoreactive to the vanilloid receptor protein: Distribution in the urinary bladder. Neurourol Urodynam 19:456, 2000.

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: October 24, 2013
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
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
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 April 17, 2014