AUA 2009: Tadalafil Effective for Urinary Symptoms of Prostatic Hypertrophy

Martha Kerr

May 03, 2009

May 3, 2009 (Chicago, Illinois) — Tadalafil (Cialis, Eli Lilly), approved for the treatment of erectile dysfunction (ED), also improves the bladder outlet obstruction index (BOOI) and symptoms of lower urinary tract symptoms in patients with benign prostatic hypertrophy (BPH-LUTS), researchers reported here at the 2009 annual meeting of the American Urological Association.

Results of a study of 200 men aged 40 years and older with BPH-LUTS for at least 6 months and an International Prostate Symptom Score (IPSS) of at least 13 were presented by lead investigator Claus Roehrborn, MD, professor and chair of urology at the University of Texas Southwestern Medical Center in Dallas.

Men were randomly assigned to received tadalafil, 20 mg daily, or placebo for 12 weeks. Subjects were divided into 3 groups according to baseline BOOI: mild (between 13 – 20), moderate (between 20 – 40), and severe (BOOI above 40), and according to LUTS severity: moderate (LUTS below 20) and severe (LUTS score ≥20).

Multiple pressure-flow and free-flow urodynamic measures were taken and IPSS was assessed at follow-up.

After 12 weeks, "...the proportion of obstructed patients in the placebo group increased, while the proportion in the tadalafil group decreased," Dr. Roehrborn told AUA meeting attendees.

"Relative symptom improvement in IPSS was significantly better for tadalafil than placebo," he added.

Total IPSS after 12 weeks of tadalafil treatment decreased 4.22 points (P < .001), obstructive symptoms (BOOI) declined 2.83 points (P < .001), and symptoms of bladder irritation decreased 1.39 points (P = .006) compared with placebo.

While Dr. Roehrborn acknowledged that the results were not strongly significant, "...the results of this study indicate that tadalafil 20 mg once daily may have an impact on obstruction."

AUA spokesperson Ira D. Sharlip, MD, professor of urology at the University of California at San Francisco, told Medscape Urology that " improvement of at least 3 points is clinically meaningful," so that although the statistical numbers were not strongly positive, the clinical implications were.

The study was supported by Eli Lilly, maker of tadalafil. Dr. Sharlip has disclosed no relevant financial relationships.

American Urological Association (AUA) 104th Annual Scientific Meeting: Abstract 1924. Presented April 29, 2009.