A Research Study for Patients With Overactive Bladder

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168454
• Other study ID #: 191622-077
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: October 11, 2013
• Start date: July 2005
• Est. completion date: June 2008

Study information

• Verified date: October 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: June 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Must be between 18-85 years old

• Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago

• Must weigh at least 50 kg (110 lbs)

• Must be willing and able to record information regarding bladder function into a diary (provided)

• Must be willing and able to complete the entire course of the study

Exclusion Criteria:

• Cannot currently be catheterizing as a way to control incontinence

• Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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
• Urinary Incontinence

Intervention

Biological:
• botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1

Drug:
• Placebo
Placebo (normal saline) injected into detrusor on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of Urinary Urge Incontinence Episodes	Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.	Baseline, Week 2, Week 6, Week 12	No
Secondary	Change in Number of Micturitions	Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.	Baseline, Week 2, Week 6, Week 12	No
Secondary	Change in Number of Nocturia Episodes	Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.	Baseline, Week 12	No
Secondary	Maximum Cystometric Capacity (MCC) by Urodynamic Measurements	Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters	Baseline, Week 12	No
Secondary	Incontinence Quality of Life Instrument (I-QOL)	Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.	Baseline, Week 2, Week 6, Week 12	No