PURPOSE: Bladder dysfunction influences recovery of urinary continence after radical prostatectomy.
We performed a multi-center, randomized, double-blind study evaluating Solifenacin vs placebo on return to continence in patients who were still incontinent 7-21 days after catheter removal following RARP.
MATERIALS AND METHODS: A wireless PDA was given to patients the day of catheter removal. Encrypted answers were transmitted daily to dedicated servers. After a 7 to 21-day treatment-free wash-out period, patients requiring 2 to 10 PPD for 7 consecutive days were randomized (1:1) to 5 mg of Solifenacin daily or placebo. The primary endpoint was time interval from first dose to continence defined as 0 PPD or a dry security pad for 3 consecutive days. Secondary endpoints included proportion of patient's continent at end of study, average change in PPD number and quality of life assessments.
RESULTS: 1086 screened patient's recorded PDA information. 640 were randomized to Solifenacin vs placebo; 17 failed to take medication. There was no difference in time to continence (p=0.17). Continence was achieved by study end in 91/313(29%) vs. 66/309(21%) respectively (p=0.04). PPD change from baseline was -3.2 and -2.9, respectively (p=0.03). Dry mouth was the only common adverse event: seen in 6.1% and 0.6%, respectively. Constipation rates were similar. Overall rate of continence in the entire population from screening to end of study was 73%.
CONCLUSIONS: There was no difference on primary outcome but some secondary endpoints benefited the Solifenacin arm. The study provides level IB clinical evidence for continence outcomes after RARP.
Written by:
Bianco FJ, Albala DM, Belkoff LH, Miles BJ, Peabody JO, He W, Bradt JS, Haas GP, Ahlering TE. Are you the author?
Urological Research Network, Miami FL; Associated Medical Professionals, Syracuse NY; Urologic Consultants of Southeastern, Bala Cynwyd PA; Houston Methodist Research Institute, Houston TX; Vattikuti Urology Institute, Henry Ford Hospital, Detroit MI; Astellas, Northbrook, IL; UC Irvine, Orange CA.
Reference: J Urol. 2014 Oct 1. pii: S0022-5347(14)04586-8.
doi: 10.1016/j.juro.2014.09.106
PubMed Abstract
PMID: 25281778