Surgery Section - Nerve Graft in Association with Radical Prostatectomy

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

Nerve grafting is performed to replace cavernous nerves that have been resected during radical prostatectomy for prostate cancer. The intent of this nerve grafting is to treat the erectile dysfunction that is a common problem when nerve sparing surgical techniques are unsuccessful or cannot be accomplished due to the location or extent of the tumor. The sural nerve, the most common donor nerve, is considered expendable and has been used extensively in other nerve grafting procedures, such as brachial plexus and peripheral nerve injuries. A portion of the sural nerve is harvested from one leg and then anastomosed to the divided ends of the cavernous nerve.    Other nerves, such as the genitofemoral nerve, have also been used. Grafting may be unilateral or bilateral.

POLICY/CRITERIA

Unilateral or bilateral nerve graft is considered investigational in patients who have undergone resection of one or both neurovascular bundles as part of a radical prostatectomy.

POSITION STATEMENT

There is insufficient evidence in the current published literature to establish the safety and effectiveness of nerve grafting as a treatment of cavernous nerve resection during radical prostatectomy.

• There are no randomized controlled trials demonstrating improved spontaneous erectile function or urinary function with nerve grafting compared to nerve sparing procedures.
  
• There are no clinical trial data on the potential complications of this surgery or the rate of complications compared to nerve sparing procedures.

Effectiveness

There is only one randomized, controlled trial which compared unilateral nerve sparing radical prostatectomy with versus without unilateral sural nerve grafting. (2)

• The trial was discontinued before full enrollment was achieved because there was adequate data at interim analysis of 107 patients with 2-year follow-up to determine that nerve grafting was not beneficial.
• At 2-year follow-up, there was no significant difference in erectile or urinary function, quality of life or time to potency between the two groups.
• The results of this trial warrant cautious interpretation. Patients were not blinded to their treatment group assignment, thus, the possibility of treatment bias cannot be ruled out.

The remainder of the literature on nerve grafting in association with prostatectomy consists of case series data. (3-10)  While these studies contribute to the body of knowledge by providing direction for future research, evidence from these studies is unreliable due to inherent design flaws, such as non-random allocation of treatment and lack of appropriate comparison groups.

Safety

There are limited safety data specific to nerve grafting performed with radical prostatectomy.  Reported donor site side effects include incisional pain and sensory deficit along the lateral aspect of the foot.

REFERENCES

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.81
2. Davis JW, Chang DW, Chevray P, et al. 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. Eur Urol. 2008 Sep 2. [Epub ahead of print]
3. Kim ED, Nath R, Kadmon D et al. Bilateral nerve graft during radical retropubic prostatectomy: extended follow-up.  Urology  2001;58(6):983-7
4. Canto EI, Nath RK, Slawin KM. Cavermap-assisted sural nerve interposition graft during radical prostatectomy. Urol Clin North Am 2001;28(4):839-48
5. Singh H, Karakiewicz P, Shariat SF, et al.  Impact of unilateral interposition sural nerve grafting on recovery of urinary function after radical prostatectomy.  Urology  2004;64(6):1122-7
6. Secin FP, Koppie TM, Scardino PT et al.  Bilateral cavernous nerve interposition grafting during radical retropubic prostatectomy: Memorial Sloan-Kettering Cancer Center experience.  J Urol  2007;177(2):664-8
7. Sim HG, Kliot M, Lange PH et al.  Two-year outcome of unilateral sural nerve interposition graft after radical prostatectomy.  Urology  2006;68(6):1290-4
8. Nelson BA, Chang SS, Cookson MS et al.  Morbidity and efficacy of genitofemoral nerve grafts with radical retropubic prostatectomy.  Urology  2006;65(4):789-92
9. Zorn KC, Bernstein AJ, Gofrit ON et al.  Long-term functional and oncological outcomes of patients undergoing sural nerve interposition grafting during robot-assisted laparoscopic radical prostatectomy.  J Endourol  2008 Apr 17 [Epub ahead of print]
10. Namiki S, Saito S, Nakagawa H et al.  Impact of unilateral sural nerve graft on recovery of potency and continence following radical prostatectomy: 3-year longitudinal study.  J Urol  2007;178(1):212-6

CROSS REFERENCES

None

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