A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy
Abstract
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.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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