Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Botox; Placebo
Intervention description: Botox injection; Placebo injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: Male
Minimum age: 40 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: OAB

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:
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male outpatients of any race, between 40 and 90 years of age.

          2. Clinical signs and symptoms of frequency (>=8 micturitions/day) and urgency (>=2
             episodes/day).

          3. 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.

          4. OAB inadequately controlled with anticholinergic medications, as per Investigator
             opinion.

          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.

          8. Able to understand the requirements of the study, including completing questionnaires
             and signing Informed Consent/HIPAA.

        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. Known history of clinically significant cardiovascular disease, cerebrovascular
             disease, or arrhythmia.

          3. History of spinal cord injury or multiple sclerosis, or other neurological disease
             which may be contributing to OAB.

          4. Known history of hydronephrosis.

          5. Current indwelling catheter, or removal of chronic catheter <1 month prior to study
             entry.

          6. Non-compliance with wash-out periods for prohibited medications/therapies (Supplement
             I).

          7. Evidence of Urinary Tract Infection according to local standard of care.

          8. Serum PSA of >10ng/mL.

          9. 24 hour total volume voided >3000 mL of urine. [As determined by completion of a
             patient bladder diary during the screening period]

         10. 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.

         11. Allergy or sensitivity to any component of BOTOX® (Section 5.2).

         12. Known uncontrolled systemic disease.

         13. Evidence of recent alcohol/drug abuse.

         14. 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.

         15. History of poor cooperation, non-compliance with medical treatment, or unreliability.