TY - JOUR
T1 - A Clinical Learning Curve Study of Polydimethylsiloxane Urolastic for Stress Urinary Incontinence
T2 - Does Safety Improve when Expertise Grow?
AU - Casteleijn, Fenne
AU - Latul, Yani
AU - van Eekelen, Rik
AU - Roovers, Jan-Paul
N1 - Funding Information: A non-restricted research grant from Urogyn BV, the Netherlands was provided. Publisher Copyright: © 2023 S. Karger AG, Basel.
PY - 2023/8/1
Y1 - 2023/8/1
N2 - OBJECTIVES: The aim of the study was to characterize the learning curve of bulk injection therapy polydimethylsiloxane Urolastic (PDMS-U) for stress urinary incontinence. DESIGN: Secondary analysis from three clinical studies on efficacy and safety outcomes of PDMS-U was performed. PARTICIPANTS/MATERIALS, SETTING, METHODS: PDMS-U-certified physicians who performed ≥4 procedures were included. The primary outcome was the number of PDMS-U procedures needed to achieve acceptable failure rates for "complications overall," "urinary retention," and "excision," using the LC-CUSUM method. For the primary outcome, physicians who performed ≥20 procedures were used. For the secondary outcome, logistic and linear regression analysis was used to assess the relationship between number of procedures, complications (complications overall, urinary retention, pain, exposure, excision of PDSM-U), and duration of treatment. RESULTS: In total, 203 PDMS-U procedures were performed by nine physicians. Five physicians were used for the primary outcome. For "complications overall," "urinary retention," and "excision," two physicians reached a level of competence: one at procedure 20 and one at procedure 40. The secondary outcome showed no statistically significant association between procedure number and complications. There was a statistically significant increase in the duration of treatment with more physician experience (mean difference 0.83 min per 10 additional procedures, 95% CI: 0.16-1.48). LIMITATIONS: One limitation is that retrospectively collected data might have underreported the number of complications. Secondly, there was variation in the way the technique was applied between physicians. CONCLUSIONS: Physicians' experience in the PDMS-U procedure did not influence safety outcomes. There was large inter-physician variability and most physicians did not reach acceptable failure rates. There was no relationship between PDMS-U complications and the number of performed procedures.
AB - OBJECTIVES: The aim of the study was to characterize the learning curve of bulk injection therapy polydimethylsiloxane Urolastic (PDMS-U) for stress urinary incontinence. DESIGN: Secondary analysis from three clinical studies on efficacy and safety outcomes of PDMS-U was performed. PARTICIPANTS/MATERIALS, SETTING, METHODS: PDMS-U-certified physicians who performed ≥4 procedures were included. The primary outcome was the number of PDMS-U procedures needed to achieve acceptable failure rates for "complications overall," "urinary retention," and "excision," using the LC-CUSUM method. For the primary outcome, physicians who performed ≥20 procedures were used. For the secondary outcome, logistic and linear regression analysis was used to assess the relationship between number of procedures, complications (complications overall, urinary retention, pain, exposure, excision of PDSM-U), and duration of treatment. RESULTS: In total, 203 PDMS-U procedures were performed by nine physicians. Five physicians were used for the primary outcome. For "complications overall," "urinary retention," and "excision," two physicians reached a level of competence: one at procedure 20 and one at procedure 40. The secondary outcome showed no statistically significant association between procedure number and complications. There was a statistically significant increase in the duration of treatment with more physician experience (mean difference 0.83 min per 10 additional procedures, 95% CI: 0.16-1.48). LIMITATIONS: One limitation is that retrospectively collected data might have underreported the number of complications. Secondly, there was variation in the way the technique was applied between physicians. CONCLUSIONS: Physicians' experience in the PDMS-U procedure did not influence safety outcomes. There was large inter-physician variability and most physicians did not reach acceptable failure rates. There was no relationship between PDMS-U complications and the number of performed procedures.
KW - Bulking agent
KW - Learning curve
KW - Stress urinary incontinence
UR - http://www.scopus.com/inward/record.url?scp=85169173670&partnerID=8YFLogxK
U2 - https://doi.org/10.1159/000530666
DO - https://doi.org/10.1159/000530666
M3 - Article
C2 - 37231857
SN - 0378-7346
VL - 88
SP - 240
EP - 248
JO - Gynecologic and Obstetric Investigation
JF - Gynecologic and Obstetric Investigation
IS - 4
ER -