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

This study has been completed.
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: June 25, 2014
Last verified: June 2014
  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 Urinary Distress Inventory (UDI-6) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Efficacy:

    Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.

    The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly".

    The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).

    Safety:

    Systemic adverse events


  • Net Change of the Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Efficacy:

    Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.

    The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly".

    Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).

    Safety:

    Systemic adverse events


  • Net Change of the Quality of Life Index (QoL-I) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Efficacy:

    Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 "Delighted" to 6 "Terrible". The QoL-I ranges 0 to 6

    Safety:

    Systemic adverse events



Secondary Outcome Measures:
  • Net Change of the Cystometric Bladder Capacity (CBC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Efficacy:

    Net change of the cystometric bladder capacity (CBC) from baseline and 12 months

    Safety:

    Systemic adverse events


  • Net Change of the Bladder Compliance [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.

    Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).

    Efficacy:

    Net change of the bladder compliance from baseline and 12 months

    Safety:

    Systemic adverse events


  • Net Change of the Maximum Flow Rate (Qmax) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Efficacy:

    Net change of the maximum flow rate (Qmax) from baseline and 12 months

    Safety:

    Systemic adverse events


  • Net Change of the Void Volume [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Efficacy:

    Net change of the void volume from baseline and 12 months

    Safety:

    Systemic adverse events


  • Net Change of the Detrusor Pressure (Pdet) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Efficacy:

    Net change of the detrusor pressure (Pdet) from baseline and 12 months

    Safety:

    Systemic adverse events


  • Net Change of the Postvoid Residual Volume (PVR) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    Efficacy:

    Net change of the postvoid residual volume (PVR) from baseline and 12 months

    Results:

    Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.

    Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.

    Safety:

    Systemic adverse events



Other Outcome Measures:
  • Autonomic Dysreflexia [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: September 2012
Study Completion Date: December 2013
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
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 GFR at baseline.
  • Patients with NDO induced urinary incontinence who have adequate hand function or have a care-giver available for 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 BTX-A or constituent ingredients of BTX-A.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan, 970
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
Results First Received: May 16, 2014
Last Updated: June 25, 2014
Health Authority: Taiwan: Department of Health
Taiwan: Research Ethics Committee

Keywords provided by Buddhist Tzu Chi General Hospital:
Nerve growth factor
P2X3 receptor
Transient Receptor Potential Vanilloid 1 (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 August 20, 2014