Assessment of early continence after reconstruction of the periprostatic tissues in patients undergoing computer assisted (robotic) prostatectomy: results of a 2 group parallel randomized controlled trial.

PURPOSE: Several case series have shown that reconstruction of the anterior or posterior periprostatic tissues facilitates early return of urinary continence after radical prostatectomy. We conducted a randomized clinical trial comparing early continence rates in patients undergoing urethrovesical anastomosis with or without periprostatic reconstruction.
MATERIALS AND METHODS: A total of 116 consecutive patients undergoing computer assisted (robotic) prostatectomy performed by 1 of 2 experienced surgeons were randomized to single (without periprostatic reconstruction) or double layer (with periprostatic tissue reconstruction) urethrovesical anastomosis. Urinary loss was measured by pad weight at 1, 2, 7 and 30 days after catheter removal. Patients and data gatherers were blinded to treatment allocation.
RESULTS: There were 57 patients randomized to the single and 59 to the double layer anastomosis group. All patients completed the study and followup. Using the conventional definition of urinary continence (0 to 1 pads daily) 26% and 34%, 49% and 46%, 51% and 54%, and 74% and 80% of patients undergoing single layer or double layer anastomoses were continent at 1, 2, 7 and 30 days, respectively (p >0.1). Of the patients in the 2 groups 7% and 15%, 14% and 14%, 16% and 20%, and 47% and 42% had no urinary leakage (0 gm or 0 pads daily) at these intervals, respectively (p >0.1). In each group 1 patient required prolonged catheterization because of cystographic evidence of anastomotic leakage. There were no other complications.
CONCLUSIONS: Early urinary continence rates were high in patients undergoing single or double layer urethrovesical anastomosis. We found no improvement in early continence rates with reconstruction of the periprostatic tissues.

RCT Entities:   Population Interventions Outcomes