Long-term experience utilizing a new balloon expandable prostatic endoprosthesis: the Titan stent. North American Titan Stent Study Group.

OBJECTIVES

To determine the long-term safety and efficacy of the Titan endoprosthesis as a therapeutic alternative in the management of men with bladder outlet obstruction.

METHODS

One hundred forty-four patients (mean age, 73.5 years +/- 4.2) had placement of the Titan stent. The stents were inserted under direct vision and expanded to 33 F using a balloon catheter. Of the 144 patients, 59 (41%) were in urinary retention and 85 (59%) presented with moderate to severe symptoms of prostatism. Patients were assessed at baseline and in follow-up at 1, 3, 6, 12, 18, and 24 months. Parameters of evaluation included the Madsen-Iversen symptom questionnaire, peak flow rate (Qmax), postvoid residual urine volume (PVR), and incidence of adverse events.

RESULTS

At 24 months, for the retention cohort, symptoms, Qmax, and PVR were 5.21 +/- 0.81, 11.34 +/- 1.12 mL/s, and 31.00 +/- 12.8 mL, respectively (P < 0.002). For patients with symptoms of bladder outlet obstruction, the results were as follows at 24 months: (1) symptoms decreased from 15.89 +/- 0.47 to 9.33 +/- 0.86 (P < 0.001); (2) Qmax increased from 8.59 +/- 0.41 mL/s to 11.43 +/- 1.12 mL/s (P < 0.001); and (3) PVR decreased from 116.94 +/- 19.95 mL to 74.4 +/- 36.2 mL (P < 0.03). There were minimal complications; stents were removed from 28 patients (19%) because of migration, 10 of which were placed by one investigator.

CONCLUSIONS

When properly placed, the Titan stent was an effective therapeutic alternative to prostatectomy or long-term catheterization in high-risk obstructed patients or those in urinary retention.