This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00479596
• Date of registration: 25/05/2007
• Primary sponsor: Urological Sciences Research Foundation
• Public title: This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo. BTX0621
• Scientific title: Safety and Efficacy Study of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction (BTX0621)
• Date of first enrolment: January 2007
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00479596
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Malu Macairan, M.D.

• Name: Leonard S Marks, M.D.

• Name: Leonard S Marks, M.D.
• Affiliation: Urological Sciences Research Foundation

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male between 40 and 90 years of age.

2. Clinical signs and symptoms of frequency and urgency

3. Urodynamic history consistent with OAB that developed in conjunction with Benign
Prostate Obstruction and that persists for at least 3 months post TURP or PVP, or
other obstruction relieving procedure.

4. OAB inadequately controlled with anticholinergic medications

5. Qmax >12mL/s with a voided volume of >125mL.

6. IPSS >12, with IPSS QoL >3 at study Visit 1.

7. Willing to use clean intermittent catheterization (CIC) to empty the bladder or is
willing to have an indwelling catheter, if necessary following study treatment.

Exclusion Criteria:

1. Known history of interstitial cystitis, uninvestigated hematuria, bladder outlet
obstruction due to vesical neck contracture, mullerian duct cysts, urethral
obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis,
genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.

2. Current indwelling catheter, or removal of chronic catheter <1 month prior to study
entry.

3. Non-compliance with wash-out periods for prohibited medications/therapies

4. Evidence of Urinary Tract Infection according to local standard of care.

5. History of prostate cancer.

6. Serum PSA of >10ng/mL. [NOTE: Subjects with serum PSA concentrations >4 and <10 must
have prostate cancer excluded according to the local standard of care.]

7. 24 hour total volume voided >3000 mL of urine

8. Medical condition that may increase their risk of exposure to botulinum toxin
including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral
Sclerosis or any other disease that might interfere with neuromuscular function.

9. Allergy or sensitivity to any component of BOTOX®



Age minimum: 40 Years
Age maximum: 90 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

Drug: Botox

Primary Outcome(s)

Safety and efficacy of BOTOX? to placebo (saline) in the treatment of OAB secondary to BPO. [Time Frame: 6 months post injection]

Secondary Outcome(s)

Patient satisfaction to intradetrussor injection of Botox versus placebo. [Time Frame: 6 months post injection]

Secondary ID(s)

BTX0621

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Allergan