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

NCT01682603 | Completed Phase 2 Results

• 1 other identifier: TCGHUROL005
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

Nerve growth factor; P2X3 receptor; Transient Receptor Potential Vanilloid 1 (TRPV-1) receptor; Bladder function; Glomerular filtration rate; Detrusor overactivity; Spinal cord injury

Outcome Measures

Primary Outcomes (3)

• Net Change of the Urinary Distress Inventory (UDI-6)

  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

  Baseline and 12 months

• Net Change of the Incontinence Impact Questionnaire (IIQ-7)

  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

  Baseline and 12 months

• Net Change of the Quality of Life Index (QoL-I)

  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

  Baseline and 12 months

Secondary Outcomes (6)

• Net Change of the Cystometric Bladder Capacity (CBC)

  Baseline and 12 months

• Net Change of the Bladder Compliance

  Baseline and 12 months

• Net Change of the Maximum Flow Rate (Qmax)

  Baseline and 12 months

• Net Change of the Void Volume

  Baseline and 12 months

• Net Change of the Detrusor Pressure (Pdet)

  Baseline and 12 months

Other Outcomes (1)

• Autonomic Dysreflexia

  Baseline and 12 months

Study Arms (1)

Botulinum toxin A

EXPERIMENTAL

BoNT-A (BOTOX 300U)

Drug: Botulinum toxin A

Interventions

Botulinum toxin A DRUG

BoNT-A (BOTOX 300U)

Also known as: BoNT-A (BOTOX 300U)

Botulinum toxin A

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

Location

Related Publications (49)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Hereditary Sensory and Autonomic Neuropathies; Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Hann-Chorng Kuo
• Organization: Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

hck@tzuchi.com.tw

886-3-8561825

Study Officials

• Hann-Chorng Kuo, M.D.

  Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 20, 2017
• Results First Posted: July 23, 2014

Record last verified: 2014-06

Locations

TW (1)