A Phase 4 interventional study of Radical prostatectomy with implantation of allograft and Radical prostatectomy without implantation of allograft in Erectile Dysfunction Following Radical Prostatectomy, sponsored by Kantonsspital Winterthur KSW. Terminated at 1 site in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Kantonsspital Winterthur KSW · Phase 4, Interventional, and Treatment
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.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Kantonsspital Winterthur KSW is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radical prostatectomy without implantation of allograft
Procedure: Radical prostatectomy without implantation of allograft
Radical prostatectomy with implantation of allograft
Biological: Radical prostatectomy with implantation of allograft
Interposition of resected neurovascular bundles with allograft Avance®
No interposition of resected neurvascular bundles
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
Time frame: 24 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Monitoring of side effects and complications in connection with the nerve-implantation.
Time frame: 24 months
Documented will be the extra time required for the nerve implantation
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.
Time frame: at the time of operation
This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Kantonsspital Winterthur KSW