Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach.

NCT00262496 | Withdrawn Phase 2

• 1 other identifier: 3216-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether Botulinum-A toxin injected in the bladder muscle will help prevent the frequency and degree of urinary incontinence in Spinal Cord Injured and Multiple Sclerosis patients. The proposed mechanism would be that the Toxin would allow the bladder to hold more urine at a lower pressure as determined by Urodynamics. The research will answer the question whether the dosages 300 units vs 400 units are either equally vs not equally effective in helping urinary incontinece and bladder storage.

Conditions

Overactive Bladder; Urinary Incontinence

Keywords

Botox; Overactive bladder; Incontinence; Spinal Cord Injury

Interventions

Botox DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18-80 years old with suprasacral spinal cord injury (SCI) or multiple sclerosis (MS) refractory Neurogenic bladder overactivity and/or detrusor compliance associated with small bladder capacity.· Impaired bladder compliance less than 50 ml/cm, H2O and bladder (cystometric) capacity less than 300ml.-

You may not qualify if:

• Allergy to Botulinum Toxin Type-A· Pregnancy· Breast-feeding women· Active medical or psychiatric disorders· Upper urinary tract changes unrelated to lower tract dysfunction· Aminoglycoside use during the last 3 months-

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Miami VA Medical Center

Miami, Florida, 33125, United States

Location

Related Publications (5)

• Schulte-Baukloh H, Weiss C, Schobert J, Stolze T, Sturzebecher B, Knispel HH. [Subjective patient satisfaction after injection of botulinum-a toxin in detrusor overactivity]. Aktuelle Urol. 2005 Jun;36(3):230-3. doi: 10.1055/s-2004-830203. German.

  PMID: 16001338 BACKGROUND

• Schurch B, de Seze M, Denys P, Chartier-Kastler E, Haab F, Everaert K, Plante P, Perrouin-Verbe B, Kumar C, Fraczek S, Brin MF; Botox Detrusor Hyperreflexia Study Team. Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. J Urol. 2005 Jul;174(1):196-200. doi: 10.1097/01.ju.0000162035.73977.1c.

  PMID: 15947626 BACKGROUND

• Werner M, Schmid DM, Schussler B. Efficacy of botulinum-A toxin in the treatment of detrusor overactivity incontinence: a prospective nonrandomized study. Am J Obstet Gynecol. 2005 May;192(5):1735-40. doi: 10.1016/j.ajog.2004.11.052.

  PMID: 15902187 BACKGROUND

• Bagi P, Biering-Sorensen F. Botulinum toxin A for treatment of neurogenic detrusor overactivity and incontinence in patients with spinal cord lesions. Scand J Urol Nephrol. 2004;38(6):495-8. doi: 10.1080/00365590410015867.

  PMID: 15841785 BACKGROUND

• Grosse J, Kramer G, Stohrer M. Success of repeat detrusor injections of botulinum a toxin in patients with severe neurogenic detrusor overactivity and incontinence. Eur Urol. 2005 May;47(5):653-9. doi: 10.1016/j.eururo.2004.11.009. Epub 2005 Jan 15.

  PMID: 15826758 BACKGROUND

Related Links

• South Florida VA Foundation for Research
• American Spinal Injury Association

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Spinal Cord Injuries

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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; Urination Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

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

Study Officials

• Angelo E Gousse, MD

  Miami VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 6, 2005
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (1)