OBJECTIVE: To evaluate the efficacy and safety of a biodegradable self-reinforced poly-DL-lactic acid (SR-PLA) spiral stent compared with a suprapubic catheter after visual laser ablation of the prostate (VLAP) in a randomized study. PATIENTS AND METHODS: The study comprised 45 patients (mean age 67.6 years, range 52-81) with bladder outlet obstruction caused by benign prostatic hyperplasia who received either aSR-PLA stent (22 patients) and asuprapubic catheter, or a suprapubic catheter only (23 patients) after undergoing VLAP. The suprapubic catheter was removed when voiding started. The response to VLAP and the effect of the stent or catheter were assessed using symptom scores, peak flow rate (Qmax), post-void residual volume (PVR), stent degradation, infection and outcome. RESULTS: Voiding started on the first or second day after treatment in 18 (median one day) of 22 patients with a spiral stent and in eight (median 6 days) of 23 patients with only the suprapubic catheter. The mean degradation time of the SR-PLA stent was 6 months; spiral fragments were found in the prostatic urethra or the urinary bladder in 20 of the patients on cystoscopy. Improvements in patient-weighted symptom score, mean Qmax and PVR were significant in both groups at the 6 month follow-up. The infection rate increased with the duration of suprapubic catheterization, from 25% (0-3 days) to 44% (> 3 days). Stones were seen in two stented patients during the follow-up. CONCLUSION: The SR-PLA spiral stent is safe and effective for the treatment of post-operative urinary retention after laser therapy. The degradation time of the stent was unnecessarily long compared with the duration of prostatic swelling and tissue sloughing after laser therapy. The infection rate depends on the duration of suprapubic catheterization.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of a biodegradable self-reinforced poly-DL-lactic acid (SR-PLA) spiral stent compared with a suprapubic catheter after visual laser ablation of the prostate (VLAP) in a randomized study. PATIENTS AND METHODS: The study comprised 45 patients (mean age 67.6 years, range 52-81) with bladder outlet obstruction caused by benign prostatic hyperplasia who received either a SR-PLA stent (22 patients) and a suprapubic catheter, or a suprapubic catheter only (23 patients) after undergoing VLAP. The suprapubic catheter was removed when voiding started. The response to VLAP and the effect of the stent or catheter were assessed using symptom scores, peak flow rate (Qmax), post-void residual volume (PVR), stent degradation, infection and outcome. RESULTS: Voiding started on the first or second day after treatment in 18 (median one day) of 22 patients with a spiral stent and in eight (median 6 days) of 23 patients with only the suprapubic catheter. The mean degradation time of the SR-PLA stent was 6 months; spiral fragments were found in the prostatic urethra or the urinary bladder in 20 of the patients on cystoscopy. Improvements in patient-weighted symptom score, mean Qmax and PVR were significant in both groups at the 6 month follow-up. The infection rate increased with the duration of suprapubic catheterization, from 25% (0-3 days) to 44% (> 3 days). Stones were seen in two stented patients during the follow-up. CONCLUSION: The SR-PLA spiral stent is safe and effective for the treatment of post-operative urinary retention after laser therapy. The degradation time of the stent was unnecessarily long compared with the duration of prostatic swelling and tissue sloughing after laser therapy. The infection rate depends on the duration of suprapubic catheterization.
Authors: Ilkka Uurto; Andres Kotsar; Taina Isotalo; Joonas Mikkonen; Paula M Martikainen; Minna Kellomäki; Pertti Törmälä; Teuvo L J Tammela; Martti Talja; Juha-Pekka Salenius Journal: J Mater Sci Mater Med Date: 2007-04-17 Impact factor: 3.896