A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy.
Dalela D, Jeong W, Prasad MA, Sood A, Abdollah F, Diaz M, Karabon P, Sammon J, Jamil M, Baize B, Simone A, and Menon M. A pragmatic randomized controlled trial examining the impact of the retzius-sparing approach on early urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol 2017; 72(5):677-685.
BACKGROUND: Retzius-sparing (posterior) robot-assisted radical prostatectomy (RARP) may expedite postoperative urinary continence recovery.
OBJECTIVE: To compare the short-term (≤3 mo) urinary continence (UC), urinary function (UF), and UF-related bother outcomes of posterior RARP compared with standard anterior approach RARP.
DESIGN, SETTING, AND PARTICIPANTS: A total of 120 patients aged 40-75 yr with low-intermediate-risk prostate cancer (per the National Comprehensive Cancer Network guidelines) underwent primary RARP at a tertiary care institution.
INTERVENTION: Eligible men were randomized to receive either posterior (n=60) or anterior (n=60) RARP.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: Primary outcome was UC (defined as 0 pads/one security liner per day) 1 week after catheter removal. Secondary outcomes were short-term (≤3 mo) UC recovery, and UF and UF-related bother scores (measured by the International Prostate Symptom Score [IPSS] and IPSS quality-of-life scores, respectively) assessed at 1 and 2 wk, and 1 and 3 mo following catheter removal. Continence outcomes were objectively verified using 24-hr pad weights. UC recovery was analyzed using Kaplan-Meier method and Cox proportional hazards regression; UF and UF-related bother outcomes were compared using linear generalized estimating equations (GEEs). Perioperative complications, positive surgical margin, and biochemical recurrence-free survival (BCRFS) represent secondary outcomes reported in the study.
RESULTS AND LIMITATIONS: Compared with 48% in the anterior arm, 71% men undergoing posterior RARP were continent 1 wk after catheter removal (p=0.01); corresponding median 24-h pad weights were 25 and 5g (p=0.001). Median time to continence in posterior versus anterior RARP was 2 and 8 d postcatheter removal, respectively (log-rank p=0.02); results were confirmed on multivariable regression analyses. GEE analyses showed that UF-related bother (but not UF) scores were significantly lower in the posterior versus anterior RARP group at 1 wk, 2 wk, and 1 mo on GEE analyses. Incidence of postoperative complications (12% anterior vs 18% posterior) and probability of BCRFS (0.91 vs 0.91) were comparable in the two arms.
CONCLUSIONS: In this single-center randomized study, the Retzius-sparing approach of RARP resulted in earlier recovery of UC and lower UF-related bother compared with standard RARP. These results require long-term validation and reproduction by other centers, as well as studies on men with high-risk localized disease.
PATIENT SUMMARY: In our hands, men with low-intermediate-risk prostate cancer undergoing Retzius-sparing robot-assisted radical prostatectomy (RARP) had earlier recovery of urinary continence and lower urinary function-related bother than those undergoing standard RARP.
Medical Subject Headings
Adult; Aged; Chi-Square Distribution; Device Removal; Humans; Incontinence Pads; Kaplan-Meier Estimate; Linear Models; Male; Margins of Excision; Michigan; Middle Aged; Multivariate Analysis; Proportional Hazards Models; Prostatectomy; Prostatic Neoplasms; Quality of Life; Recovery of Function; Risk Factors; Robotic Surgical Procedures; Tertiary Care Centers; Time Factors; Treatment Outcome; Urinary Catheterization; Urinary Catheters; Urinary Incontinence