Urology

Clinical Trials Update

Holly Kelly, RN, Clinical Research Manager

A Multi-center, Double-Blind, Placebo-controlled trial of Sanctura XR 60 mg Daily in Female OAB Patients on Multiple Concomitant Medications Refractory to Detrol LA 4 mg Daily
The study objective is to establish Sanctura XR 60 mg as an effective therapy for reducing overactive bladder (OAB) symptoms in female subjects who are on multiple concomitant medications and are still suffering from urgency urinary incontinence (UUI), despite a one month trial of Detrol LA 4 mg daily.

Main inclusion criteria are:

• Female, OAB with predominate UUI refractory to Detrol LA 4 mg daily for no less than 28 days prior to baseline
• Urinary frequency, two or more moderate to severe urgency episodes per three day patient bladder diary
• At least or >1 UUI episode as recorded in a baseline three day patient bladder diary
• Taking at least five or more multiple daily oral concomitant medications (may be prescription, non-prescription or supplement/vitamin) for stable indications other than OAB

Major exclusion criteria:

• Total void volume of >2,500 mL per day
• Predominant stress incontinence
• Insensate incontinence
• History of neurogenic bladder
• Significant renal disease (Cr >2.0 mg/dL)
• Urinary tract infections: two in the last six months
• Bladder obstruction
• Concurrent agents with anti-cholinergic activity other than Detrol LA 4 mg daily during screening
• Oral therapeutics for dementia
• Roux-en-Y gastric bypass

A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Intraprostatic Administration of BOTOX® 200 U (Botulinum Toxin Type A) Purified Neurotoxin Complex to Treat Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia
The purpose of this study is to evaluate the efficacy and safety of BOTOX for the treatment of symptoms and signs of BPH in patients previously treated with oral BPH pharmacotherapy. The study data may be used to develop a better understanding of diseases capable of being treated with BOTOX or similar drugs and to further characterize the patient population.

Main inclusion criteria:

• Male, aged 45 years and older and weight ≥ 50 kilograms or 110 pounds
• LUTS due to BPH for at least six months prior to screening
• Previous (during the last 12 months) or current use of a licensed oral treatment for BPH
• IPSS ≥ 14 prior to run-in period
• Peak urinary flow rate of ≥ 4 mL/sec, but ≤ 12 mL/sec (with a voided urine volume ≥125 mL, but ≤ 600 mL) prior to the run-in period
• Post void residual (PVR) urine volume ≤ 200 mL prior to run-in period
• Clinical enlargement of the prostate gland in the opinion of the investigator
   

Main exclusion criteria:

• Acute prostatitis within 12 months of screening
• History or evidence of chronic prostatitis
• Two or more UTIs in the 12 months prior to screening or a single UTI in the six months prior to screening
• History or evidence of bladder stones
• Symptomatic kidney stones or planned active intervention for kidney stones.
• Previous or current diagnosis of bladder cancer, prostate cancer
• History of previous prostate surgery, including minimally invasive procedures
• History of symptoms suggestive of overactive bladder
• History or evidence of anal stenosis, stricture, fissure