Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
In this prospective randomised and single-blind, clinical phase-IV study, 60 patients are
randomized into the treatment group and the control group. The follow-up is at least 24
The inclusion criteria were localized prostate cancers cT3 and/or Gleason score ≥ 7 (a or b)
and/or prostate-specific antigen (PSA) ≥ 20 ng/ml and furthermore an erectile function with
an IIEF ≥ 21 (IIEF-5).
The operation carried out is a standardised, robot assisted laparoscopic radical
prostatectomy with total excision of both neurovascular bundles.
The Outcome measurement is done with the "quality of life questionnaire before and after
prostate surgery" that includes the "International Index of Erectile Function" (IIEF)
The limitations are a small cohort, a short observation period and the lack of statistical
analysis due to a still low number of patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy. To show a complete impotence in the control group and an enhancement of the initial postoperative impotence in the treatment group
Hubert John, Chefarzt
Kantonsspital Winterthur KSW