Assessment of a new transurethral balloon dilation catheter in the treatment of urethral stricture disease.

OBJECTIVES: To assess a newly designed balloon dilation catheter for the treatment of urethral stricture disease. The dilating capability of the catheter, the tolerability and safety of the procedure, and its short-term efficacy were evaluated. METHODS: Fifty-one patients with urethral strictures underwent dilation with the UrethraMax or a coude tip balloon dilation catheter. Efficacy parameters included measurement of the American Urological Association symptom score and maximum urinary flow rate 3, 6, and 12 months after treatment. The adequacy of dilation and the degree of mucosal trauma and hematuria were assessed endoscopically, and patient pain was measured using a visual analog scale. RESULTS: Forty-three patients (84.3%) were successfully dilated, achieving a urethral caliber of 20F or greater. Dilation resulted in statistically significant improvements in both the mean American Urological Association symptom score and mean maximum urinary flow rate at 3 and 6 months. Mucosal trauma was mild in all but 4 cases, and no patient developed significant hematuria. The mean visual analog pain score was 3.9 (range 0.1 to 9.4). CONCLUSIONS: Balloon dilation is a safe, well-tolerated, office-based procedure that theoretically offers several advantages over sequential rigid dilation and internal urethrotomy. It is associated with minimal complications, and its short-term efficacy is acceptable. We regard this as the dilation procedure of choice and first-line therapy for most strictures.