TY - JOUR
T1 - Artificial urinary sphincter significantly better than fixed sling for moderate post-prostatectomy stress urinary incontinence: a propensity score-matched study
AU - Sacco, Emilio
AU - Gandi, Carlo
AU - Marino, Filippo
AU - Totaro, Angelo
AU - Di Gianfrancesco, Luca
AU - Palermo, Giuseppe
AU - Pierconti, Francesco
AU - Racioppi, Marco
AU - Bassi, Pierfrancesco
PY - 2021
Y1 - 2021
N2 - Objective: To compare the efficacy of artificial urinary sphincter (AUS) vs retrourethral transobturator sling (RTS) in men with moderate post-prostatectomy urinary incontinence (PPI) using propensity score-matching analysis to enhance the validity of the comparison (Canadian Task Force classification II-2). Patients and methods: Consecutive men with moderate (3–5 pads/day) stress-prevalent PPI were included if implanted with a RTS (TiLOOP® Male; pfm medical, Köln, Germany) or AUS (AMS800®; Boston Scientific, Boston, MA, USA) since July 2011 to December 2017 and with ≥12 months of follow-up. Preoperative assessment included 24-h pad usage, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), urethrocystoscopy, and urodynamics if indicated. Propensity score-matching analysis was based on age, body mass index, Charlson Comorbidity Index, pad usage, previous radiotherapy, and urethrotomy. The primary outcome was at least ‘much improved’ response at 12-months according to the Patient Global Impression of Improvement questionnaire, without additional PPI surgery or prosthesis explantation. Results: Of 109 included patients, 70 patients were matched and the study groups were well balanced for the baseline matched variables. The median baseline 24-h pad usage was four in both groups (P = 0.10), and median follow-up was 51.2 months for AUS and 47.2 months (P = 0.5) for RTS patients. In the AUS and RTS cohorts, respectively, 33 (94.3%) and 24 (68.6%) patients achieved the primary outcome (P < 0.001), the 0–1 pad/day rates was 94.3% vs 68.6% (P = 0.012) at 12 months, and 91.4% vs 68.6% (P = 0.034) at last follow-up. At the last follow-up, the median 24-h leakage volumes, median ICIQ-SF scores and satisfaction rates were 0 vs 15 mL (P = 0.017), 4 vs 10 (P = 0.001), and 94.3% vs 68.6% (P = 0.012) in the AUS and RTS cohorts, respectively. There were no significant differences in overall rates of complications and re-interventions, although Clavien–Dindo Grade III complications (n = 3) occurred only in the AUS group. At sensitivity analysis, the study was reasonably robust to hidden bias. Conclusion: We found that AUS implantation significantly outperformed RTS in patients with moderate PPI for both subjective and objective outcomes.
AB - Objective: To compare the efficacy of artificial urinary sphincter (AUS) vs retrourethral transobturator sling (RTS) in men with moderate post-prostatectomy urinary incontinence (PPI) using propensity score-matching analysis to enhance the validity of the comparison (Canadian Task Force classification II-2). Patients and methods: Consecutive men with moderate (3–5 pads/day) stress-prevalent PPI were included if implanted with a RTS (TiLOOP® Male; pfm medical, Köln, Germany) or AUS (AMS800®; Boston Scientific, Boston, MA, USA) since July 2011 to December 2017 and with ≥12 months of follow-up. Preoperative assessment included 24-h pad usage, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), urethrocystoscopy, and urodynamics if indicated. Propensity score-matching analysis was based on age, body mass index, Charlson Comorbidity Index, pad usage, previous radiotherapy, and urethrotomy. The primary outcome was at least ‘much improved’ response at 12-months according to the Patient Global Impression of Improvement questionnaire, without additional PPI surgery or prosthesis explantation. Results: Of 109 included patients, 70 patients were matched and the study groups were well balanced for the baseline matched variables. The median baseline 24-h pad usage was four in both groups (P = 0.10), and median follow-up was 51.2 months for AUS and 47.2 months (P = 0.5) for RTS patients. In the AUS and RTS cohorts, respectively, 33 (94.3%) and 24 (68.6%) patients achieved the primary outcome (P < 0.001), the 0–1 pad/day rates was 94.3% vs 68.6% (P = 0.012) at 12 months, and 91.4% vs 68.6% (P = 0.034) at last follow-up. At the last follow-up, the median 24-h leakage volumes, median ICIQ-SF scores and satisfaction rates were 0 vs 15 mL (P = 0.017), 4 vs 10 (P = 0.001), and 94.3% vs 68.6% (P = 0.012) in the AUS and RTS cohorts, respectively. There were no significant differences in overall rates of complications and re-interventions, although Clavien–Dindo Grade III complications (n = 3) occurred only in the AUS group. At sensitivity analysis, the study was reasonably robust to hidden bias. Conclusion: We found that AUS implantation significantly outperformed RTS in patients with moderate PPI for both subjective and objective outcomes.
KW - #Incontinence
KW - artificial urinary sphincter
KW - male incontinence
KW - male sling
KW - propensity score
KW - radical prostatectomy
KW - #Incontinence
KW - artificial urinary sphincter
KW - male incontinence
KW - male sling
KW - propensity score
KW - radical prostatectomy
UR - http://hdl.handle.net/10807/169435
U2 - 10.1111/bju.15197
DO - 10.1111/bju.15197
M3 - Article
SN - 1464-4096
VL - 127
SP - 229
EP - 237
JO - BJU International
JF - BJU International
ER -