This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo.
Status unconfirmed · Phase 2/Phase 3
Conditions studied: Overactive Bladder
In brief
The current study will investigate the comparative efficacy, safety and patient satisfaction of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in the treatment of OAB secondary to benign prostatic obstruction (BPO).
Key facts
- Study ID
- NCT00479596
- Run by
- Urological Sciences Research Foundation
- People needed
- 40
- Starts
- 2007-01-01
- Expected to finish
- 2007-05-01
- Last updated by the study team
- 2007-05-30
Who can join
Age: 40 and older, up to 90. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Male between 40 and 90 years of age.
- Clinical signs and symptoms of frequency and urgency
- 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.
- OAB inadequately controlled with anticholinergic medications
- 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.
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.
- Current indwelling catheter, or removal of chronic catheter <1 month prior to study entry.
- Non-compliance with wash-out periods for prohibited medications/therapies
- Evidence of Urinary Tract Infection according to local standard of care.
- History of prostate cancer.
- 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.]
- 24 hour total volume voided >3000 mL of urine
- 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®
Where it is running
- Urological Sciences Research Foundation — Culver City, California, United States (enrolling)
Full record on ClinicalTrials.gov
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