Status:
COMPLETED
Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Overactive Bladder
Eligibility:
MALE
40-90 years
Phase:
PHASE3
Brief Summary
This is a prospective, randomized, double-blind study comparing intravesical injection of BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following treatment groups:
Detailed Description
Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0), subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study duration is approx...
Eligibility Criteria
Inclusion
- Male outpatients of any race, between 40 and 90 years of age.
- Clinical signs and symptoms of frequency (\>=8 micturitions/day) and urgency (\>=2 episodes/day).
- Urodynamic history consistent with OAB that developed in conjunction with BPO and that persists for at least 3 months post TURP or PVP, RRP or other obstruction relieving procedure.
- OAB inadequately controlled with anticholinergic medications, as per Investigator opinion.
- Qmax \>12mL/s with a voided volume of \>125mL.
- IPSS \>12, with IPSS QoL \>3 at study Visit 1.
- Willing to use clean intermittent catheterization (CIC) to empty the bladder or is willing to have an indwelling catheter, if necessary following study treatment.
- Able to understand the requirements of the study, including completing questionnaires and signing Informed Consent/HIPAA.
Exclusion
- 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.
- Known history of clinically significant cardiovascular disease, cerebrovascular disease, or arrhythmia.
- History of spinal cord injury or multiple sclerosis, or other neurological disease which may be contributing to OAB.
- Known history of hydronephrosis.
- Current indwelling catheter, or removal of chronic catheter \<1 month prior to study entry.
- Non-compliance with wash-out periods for prohibited medications/therapies (Supplement I).
- Evidence of Urinary Tract Infection according to local standard of care.
- Serum PSA of \>10ng/mL.
- 24 hour total volume voided \>3000 mL of urine. \[As determined by completion of a patient bladder diary during the screening period\]
- 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.
- Allergy or sensitivity to any component of BOTOX® (Section 5.2).
- Known uncontrolled systemic disease.
- Evidence of recent alcohol/drug abuse.
- Subjects who, in the opinion of the Investigator, have a significant condition that puts them at significant risk, may confound study results, or interfere with study participation.
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01220726
Start Date
June 1 2009
End Date
November 13 2012
Last Update
February 26 2019
Active Locations (1)
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1
Weill Cornell Medical Center
New York, New York, United States, 10065