Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Sexual Dysfunction, Physiological

Male Urogenital Diseases

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Radical prostatectomy without implantation of allograft

Radical prostatectomy with implantation of allograft

Interposition of resected neurovascular bundles with allograft Avance®

No interposition of resected neurvascular bundles

Hubert John, Chefarzt

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.

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.

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

How much operation-time takes the nerve implantation? The time is stopped which is required for the implantation of the nerve. Start is when the prostate was removed and was deposited in the extraction bag. Stop when the anastomosis of the nerves is stitched and the anastomosis of the urethra begins.

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

Monitoring of side effects and complications in connection with the nerve-implantation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial	NCT01770340	Erectile Dysfun...	Radical prostat... Radical prostat...	18 Years -	Kantonsspital Winterthur KSW
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial	NCT01770340	Erectile Dysfun...	Radical prostat... Radical prostat...	18 Years -	Kantonsspital Winterthur KSW
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial	NCT01770340	Erectile Dysfun...	Radical prostat... Radical prostat...	18 Years -	Kantonsspital Winterthur KSW

Spots Global Cancer Trial Database for time required for nerve grafting