Medical Therapy of Prostatic Symptoms

The Medical Therapy of Prostatic Symptoms (MTOPS) study was a multi-center, randomized, double-blind placebo controlled clinical trial that tested whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or in combination, could delay or prevent the worsening of symptoms in men with benign prostatic hyperplasia (BPH). Doxazosin is an α-adrenergic receptor agonist (α-blocker) that reduces muscle tone of the prostate and bladder neck, and finasteride is a 5-α-reductase inhibitor that reduces prostate volume by inducing epithelial atrophy. The MTOPS study hypothesized that these two classes of drugs may act synergistically to delay or prevent the clinical progression of BPH.

Participants were randomly assigned, in a double-blind fashion, to one of the following 4 treatment groups: placebo, doxazosin, finasteride, or combination therapy. The primary outcome measure was time to overall clinical progression of BPH, defined as either a confirmed 4 point or greater increase from baseline in the American Urological Association (AUA) symptom score, acute urinary retention, incontinence, renal insufficiency, or recurrent urinary tract infection. The progression of BPH was also assessed using digital rectal examination, serum PSA measurement, urinalysis, transrectal ultrasound, biopsies, urinary flow, and change in the AUA score.
The study found that combination therapy with doxazosin and finasteride was more effective than either therapy alone in the preventing the clinical progression of BPH.