Cumulative summation (CUSUM) analysis of learning curves for multiple outcomes of male sling placement for post-prostatectomy urinary incontinence

Sacco E1, Bientinesi R1, Gandi C1, Vaccarella L1, Racioppi M1, Di Gianfrancesco L1, Palermo G1, Ragonese M1, Totaro A1, Pierconti F1, Bassi P1

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

Abstract 139
Incontinence from Prostate Cancer Treatment
Scientific Podium Short Oral Session 9
On-Demand
Surgery Stress Urinary Incontinence Male
1. Urology and Nephrology Dept., Fondazione Policlinico Universiario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy
Presenter
Links

Abstract

Hypothesis / aims of study
Male sling placement has been proved to be an effective treatment for postprostatectomy urinary incontinence (PPI). The existence of a learning curve (LC) has been established for sling surgery in females [1]. Male sling implantation has several critical steps and may potentially involve a LC. Scant and conflicting data are available on this topic that may have implications concerning training and evaluation of surgeons. We aimed to perform a LC analysis of a single surgeon’s experience of sling placement evaluating multiple outcomes.
Study design, materials and methods
From Jan. 2013 to Dec. 2018, consecutive patients with PPI undergoing sling placement at our institution were included. Only patients that underwent implantation of the same sling (TiLOOP Male) were included. Exclusion criteria included previous sling, incontinence due to causes different from radical prostatectomy, and follow-up lower than 12 months. 
TiLOOP Male, a 2-arm titanium-coated fixed retrourethral sling, was implanted using an inside-out, single-incision standard technique, leaving the bulbourethral muscle in place and attaining the cranial relocation of the proximal bulbar urethra [2].
LCs were derived by the cumulative sum (CUSUM) control chart analysis using the cumulative observed minus expected failure method [3]. Expected values were obtained from published literature. 
The primary outcome was the 12-months failure of objective cure (no pad use or 1 dry “security” pad). Secondary outcomes included 12-months failure of overall objective success defined as cure plus improvement (reduction of at least 50% of the pad count), 12-months failure of subjective success evaluated with PGI-I, operative time>60 minutes, need for further incontinence surgery (performed or scheduled) and overall complications occurrence. To adjust for case-mix, multivariate logistic regressions were performed using surgical order, adjusted for age, BMI, incontinence severity, pelvic irradiation, and previous urethrotomy, to predict outcomes.
Results
Sixty-five patients (mean age 68 ±5.8 years) with a mean follow-up of 46.2 ±20.5 months were included. CUSUM analyses revealed clear LC effects for continence outcomes, operative time and need for further incontinence surgery, but not for complications occurrence. LC effect was graphically more evident for objective cure than for overall objective success, with a plateau achieved after 59 cases (Figure 1).
At multivariate analyses, surgical order (OR=0.96; CI:0.93-0.99;p=0.031) and irradiation (OR=10.7; 95%CI:1.18-97.1; p=0.035) were statistically significant for predicting 12-months failure of objective cure, while irradiation was the sole variable independently predicting 12-months failure of overall objective success (OR=27.4; 95%CI: 4.8-156.3;p=0.000). Surgical order and irradiation were also independent predictors of 12-months failure of subjective success and of need for further incontinence surgery.
Interpretation of results
A rather long learning curve was observed in our series of sling placement to achieve stable proficiency, especially when objective cure was considered as continence outcome, independently from main factors involved in patient selection.
Concluding message
Individualized structured training with expert mentorship for urologists naïve in male sling surgery should likely benefit patients treated in the initial surgeon’s experience. This study supports the CUSUM analysis as an effective method for surgeons’ self-appraisal to prompt continuous quality improvement.
Figure 1 Cumulative summation (CUSUM) observed minus expected plots of sequential monitoring of failure of objective cure. Expected rate was set at 50%. The curve moves upward if there are more failure than expected and downward if there are fewer.
References
  1. Hilton P, Rose K. The “learning curve” for retropubic mid-urethral sling procedures: a retrospective cohort study. Int Urogynecol J. 2016 Apr;27(4):565-70
  2. Sacco E, Gandi C, Vaccarella L, et al. Titanized Transobturator Sling Placement for Male Stress Urinary Incontinence Using an Inside-out Single-incision Technique: Minimum 12-Months Follow-up Study. Urology. 2018;115:144-150
  3. Biau DJ, Resche-Rigon M, Godiris-Petit G, Nizard RS, Porcher R. Quality control of surgical and interventional procedures: a review of the CUSUM. Qual Saf Health Care. 2007 Jun;16(3):203-7
Disclosures
Funding No source of funding to declare. Clinical Trial No Subjects Human Ethics Committee Ethical committee of Catholic University of Rome Helsinki Yes Informed Consent Yes
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