Faculty Bibliography

OBJECTIVES/OBJECTIVE:To evaluate the ability of a temporary prostatic stent (Spanner [Sp]) to manage voiding symptoms, irritative symptoms, and bother after transurethral microwave thermotherapy (TUMT) for prostatic obstruction. METHODS:Patients were randomized to the Sp (n = 100) or standard of care (SOC, n = 86) after TUMT with 3 to 10 days of routine catheterization. We evaluated International Prostate Symptom Score (IPSS) voiding subscore, IPSS irritative subscore, voiding diary data, and Benign Prostatic Hyperplasia Impact Index (BII) 7 to 10 days before TUMT and repeated them 1, 2, 4 (stent removal), 5, and 8 weeks after stent insertion. RESULTS:After 1 week of stent use, the Sp group experienced significantly greater improvements in the IPSS voiding subscore (Sp = -4.9 versus SOC = -2.3, P = 0.002) and individual voiding symptoms assessed by the IPSS (intermittency, weak stream, and straining) and voiding diary data (stream strength, and strain). After 2 weeks, the Sp group showed a trend toward greater improvements in IPSS voiding (P = 0.059) and irritative (P = 0.058) subscores and reported significantly less bother (BII, Sp = -2.1 versus SOC = -1.1, P = 0.033). After stent removal, the Sp group reported significantly greater improvements in the IPSS irritative subscore (5 weeks: Sp = -4.0 versus SOC = -2.7, P = 0.029; 8 weeks: Sp = -5.0 versus SOC = -4.0, P = 0.050), individual voiding (stream strength and dysuria), and irritative (frequency and urgency) symptoms and bother (5 weeks: Sp = -4.0 versus SOC = -2.3, P = 0.002; 8 weeks: Sp = -5.0 versus SOC = -3.1, P = 0.001). CONCLUSIONS:The Spanner, a temporary prostatic stent, improved voiding symptoms and bother without exacerbating irritative symptoms. Improvements in symptoms and bother were sustained after stent removal.

PURPOSE/OBJECTIVE:The Spanner, a novel prostatic stent, was evaluated for safety, efficacy and patient tolerance when used to relieve prostatic obstruction following transurethral microwave thermotherapy. MATERIALS AND METHODS/METHODS:Following transurethral microwave thermotherapy and routine post-procedure Foley catheterization at 1 of 9 clinical sites 186 patients meeting study criteria were randomized to receive a Spanner (100) or the standard of care (86). Baseline evaluations included post-void residual urine, uroflowmetry, International Prostate Symptom Score and International Prostate Symptom Score quality of life question. These evaluations were repeated at visits 1, 2, 4, 5 and 8 weeks after randomization (Spanner insertion) with the addition of the Spanner satisfaction questionnaire, ease of use assessment and adverse events recording. The Spanner was removed after 4 weeks, at which time the Spanner and standard of care groups underwent cystourethroscopy. RESULTS:At the 1 and 2-week visits the Spanner group showed significantly greater improvements from baseline in post-void residual urine, uroflowmetry and International Prostate Symptom Score compared to the standard of care group. The Spanner group experienced significantly greater improvements in quality of life at the 5 and 8-week visits. Patient satisfaction with the Spanner exceeded 86%. Cystourethroscopy findings in the Spanner and standard of care groups were comparable and adverse events associated with previous stents were rare. CONCLUSIONS:The Spanner is a safe, effective and well tolerated temporary stent for severe prostatic obstruction resulting from therapy induced edema after transurethral microwave thermotherapy. It may be a needed addition to the armamentarium for managing bladder outlet obstruction in a broad group of urological patients.