Vardenafil can improve continence recovery after bilateral nerve sparing prostatectomy: results of a randomized, double blind, placebo-controlled pilot study.
BACKGROUND
Phosphodiesterase type 5 inhibitors (PDE5-I) have acquired an established role in the treatment of post-prostatectomy erectile dysfunction (ED). Several trials in men with ED and lower urinary tract symptoms associated with benign prostatic hyperplasia suggest that PDE5-I could improve both erectile function and urinary symptoms.


OBJECTIVE
To assess the role of vardenafil in continence recovery after bilateral nerve sparing radical prostatectomy (BNS-RP).


METHODS
Thirty-nine patients with prostate cancer were recruited. After BNS-RP, patients were double-blinded assigned to three arms: a) vardenafil on demand; b) vardenafil nightly; and c) placebo.


METHODS
Urinary function (UF) and urinary bother (UB) of University of California-Los Angeles Prostate Cancer Index questionnaire were assessed preoperatively and at 1, 3, 6, 9, 10, and 12 months. Twelve-month outcomes were compared to 1 month with a t-test. The differences in UF and UB (at 3, 6, 9, 10, and 12 months) between the three treatment arms were calculated by an analysis of variance. With ALLFIT we estimated half-maximal recovery times (ER50) and maximal recovery (R(max)) in three groups.


RESULTS
The improvement of UF and UB between 1 and 12 months was significant in all arms except for placebo (UF: P = 0.125; UB: P = 0.089). Nightly resulted in greater UF at 3, 6, and 9 months and greater UB at 6 months compared with placebo (P = 0.042, P = 0.044 and P = 0.039); after nightly administration, patients presented higher UB than after on-demand use, 3 and 6 months postoperatively (P = 0.036 and P = 0.017). ALLFIT demonstrated a similar ER50 in all groups (2.6 months for both UF and UB) and indicated that nightly administration induced significant improvements in R(max) compared with placebo (both <0.0001).


CONCLUSIONS
Vardenafil can improve continence recovery after BNS-RP compared with placebo. The daily use of vardenafil seems to provide better continence rate, although it does not seem to influence the timing needed to achieve full continence.
Gacci
Mauro
M
Department of Urology, University of Florence, Careggi Hospital, Florence, Italy. maurogacci@yahoo.it
Ierardi
Alessandro
A
Rose
Augusto Delle
AD
Tazzioli
Stefano
S
Scapaticci
Emanuele
E
Filippi
Sandra
S
Maggi
Mario
M
Nicita
Giulio
G
Carini
Marco
M
Montorsi
Francesco
F
D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000188:drug therapy*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000601:surgery*; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D014549:Urinary Incontinence / Q000188:drug therapy*; D014563:Urodynamics / Q000187:drug effects; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D058986:Phosphodiesterase 5 Inhibitors; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride