Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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:

Key facts

Study ID

NCT01220726

Run by

Weill Medical College of Cornell University

People needed

30

Starts

2009-06-01

Expected to finish

2012-11-13

Last updated by the study team

2019-02-26

Who can join

Age: 40 and older, up to 90. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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