NCT01770340

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Erectile Dysfunction Following Radical Prostatectomy

Interventions

Type	Name	Description
BIOLOGICAL	Radical prostatectomy with implantation of allograft	Interposition of resected neurovascular bundles with allograft Avance®
PROCEDURE	Radical prostatectomy without implantation of allograft	No interposition of resected neurvascular bundles

Timeline

• Start date: 2011-01-01
• Primary completion: 2017-04-01
• Completion: 2020-07-01
• First posted: 2013-01-17
• Last updated: 2021-02-21

Locations

1 site across 1 country: Switzerland