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Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

Official title:
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial

Clinical Trial Summary

Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft. The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.

Clinical Trial Description

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 months. 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-6). 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) questionnaire. The limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01770340
Study type Interventional
Source Kantonsspital Winterthur KSW
Contact
Status Terminated
Phase Phase 4
Start date January 2011
Completion date July 1, 2020
View Details
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