Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer.
BACKGROUND
Nonrandomized studies of unilateral nerve-sparing (UNS) radical prostatectomy (RP) have reported improved recovery of erectile function if the sacrificed cavernous nerve is reconstructed with a sural nerve graft (SNG).


OBJECTIVE
To determine whether UNS RP plus SNG results in a 50% relative increase in potency at 2 yr compared to UNS RP alone.


METHODS
The study enrolled patients from October 2001-May 2006 from a single academic center and was randomized, open label. Participants were men with localized prostate cancer recommended for UNS RP, less than 66 yr old, normal baseline erectile function, and willing to participate in early erectile dysfunction (ED) therapy. Patients were followed up to 2 yr.


METHODS
Patients underwent UNS RP and ED therapy starting at 6 wk: oral prostaglandin type-5 (PDE5) inhibitor, vacuum erection device (VED), and intracavernosal injection therapy. In the SNG group, a plastic surgeon performed the procedure at the time of RP.


METHODS
The ability to have an erection suitable for intercourse with or without a PDE5 inhibitor at 2 yr. The hypothesis was that SNG would result in a 60% potency rate compared to 40% for controls (80% power, 5% two-way significance).


CONCLUSIONS
The trial planned to enroll 200 patients, but an interim analysis at 107 patients met criteria for futility and the trial was closed. For patients completing the protocol to 2 yr, potency was recovered in 32 of 45 (71%) of SNG and 14 of 21 (67%) of controls (p=0.777). By intent-to-treat analysis, potency recovered in 32 of 66 (48.5%) of SNG and 14 of 41 (34%) of controls (p=0.271). No differences were seen in time to potency or quality of life scores for ED and urinary function. Limitations included slower-than-expected accrual and poor compliance with ED therapy: <65% for VED and <40% for injections.


CONCLUSIONS
The addition of SNG to a UNS RP did not improve potency at 2 yr following surgery.


BACKGROUND
ClinicalTrials.gov, Identifier: NCT00080808, http://www.clinicaltrials.gov/ct2/show/NCT00080808?term=NCT00080808&rank=1.
Davis
John W
JW
Department of Urology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030, USA. johndavis@mdanderson.org
Chang
David W
DW
Chevray
Pierre
P
Wang
Run
R
Shen
Yu
Y
Wen
Sijin
S
Pettaway
Curtis A
CA
Pisters
Louis L
LL
Swanson
David A
DA
Madsen
Lydia T
LT
Huber
Nelda
N
Troncoso
Patricia
P
Babaian
R Joseph
RJ
Wood
Christopher G
CG
D007172:Erectile Dysfunction / Q000209:etiology / Q000517:prevention & control*; D005500:Follow-Up Studies; D006085:Graft Survival; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009416:Nerve Regeneration / Q000502:physiology; D010410:Penile Erection / Q000502:physiology*; D010413:Penis / Q000294:innervation; D011183:Postoperative Complications / Q000503:physiopathology; D011336:Probability; D011468:Prostatectomy / Q000009:adverse effects / Q000379:methods*; D011471:Prostatic Neoplasms / Q000473:pathology* / Q000601:surgery*; D018570:Risk Assessment; D013497:Sural Nerve / Q000637:transplantation*; D013997:Time Factors; D016896:Treatment Outcome; D014554:Urination / Q000502:physiology
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