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: NCT00439140
• Other study ID #: 191622-082
• Status: Terminated
• Phase: Phase 3
• First received: February 21, 2007
• Last updated: December 9, 2013
• Start date: June 2007
• Est. completion date: December 2012

Study information

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

Clinical Trial Summary

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

Description:

Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• 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 or multiple sclerosis

• Inadequate response to anticholinergic medication used to treat overactive bladder.

• Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion Criteria:

• History or evidence of pelvic or urologic abnormality

• Previous or current diagnosis of bladder or prostate cancer

• Symptomatic or untreated urinary tract infection at time of enrollment

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

Intervention

Biological:
• botulinum toxin Type A
Botulinum toxin Type A injection into the detrusor.

Drug:
• Normal Saline (Placebo)
Placebo (Normal Saline) injection into the detrusor.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With at Least a 15% Decrease From Baseline in FVC	Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.	Baseline, Weeks 2, 6 and 12	Yes
Other	Number of Participants With at Least a 20% Decrease From Baseline in FVC	Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.	Baseline, Weeks 2, 6 and 12	Yes
Primary	Change From Baseline in Forced Vital Capacity (FVC)	Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.	Baseline, Week 6	Yes
Primary	Change From Baseline in Forced Expiratory Volume in One Second (FEV1)	Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.	Baseline, Week 6	Yes
Primary	Change From Baseline in FEV1/FVC Ratio	The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.	Baseline, Week 6	Yes
Secondary	Change From Baseline in the Number of Urinary Incontinence Episodes	The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).	Baseline, Week 6	No
Secondary	Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)	MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).	Baseline, Week 6	No
Secondary	Change From Baseline in Maximum Cystometric Capacity (MCC)	MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).	Baseline, Week 6	No