Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

Overactive Bladder Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00575016
• Other study ID #: 191622-518
• Status: Terminated
• Phase: Phase 2
• First received: December 13, 2007
• Last updated: September 17, 2015
• Start date: December 2007
• Est. completion date: July 2010

Study information

• Verified date: September 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General, India, Directorate General of Health ServicesGreece: National Drug OrganizationTurkey: Turkish Republic Ministry of HealthEgypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: July 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury

• Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

• History or evidence of pelvic or urologic abnormality

• Previous or current diagnosis of bladder or prostate cancer

• Urinary tract infection at time of enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Biological:
• Normal saline (Placebo); botulinum toxin Type A (200U)
Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
• botulinum toxin Type A (50U); botulinum toxin Type A (200U)
botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
• botulinum toxin Type A (100U); botulinum toxin Type A (200U)
botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
• botulinum toxin Type A (200U)
botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Egypt,  Greece,  India,  Lebanon,  Serbia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Number of Weekly Episodes of Urinary Incontinence	Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).	Baseline, Week 6	No
Secondary	Change From Baseline in Maximum Cystometric Capacity (MCC)	Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.	Baseline, Week 6	No
Secondary	Change From Baseline in Maximum Detrusor Pressure (MDP)	Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.	Baseline, Week 6	No