Erectile Dysfunction Following Radical Prostatectomy
Conditions
Keywords
radical prostatectomy, erectile function, nerve grafting, allogenic, prostate cancer, Allogenic nerve graft, Time required for nerve grafting
Brief 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.
Interventions
BIOLOGICALRadical prostatectomy with implantation of allograft
Interposition of resected neurovascular bundles with allograft Avance®
PROCEDURERadical prostatectomy without implantation of allograft
No interposition of resected neurvascular bundles
Sponsors
Kantonsspital Winterthur KSW
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Localized intermediate-risk or high-risk prostate cancer cT3 * Gleason score ≥ 7 (3+4 and/or 4+3) and/or * PSA ≥ 20 ng/ml * intact preoperative erectile function with an IIEF ≥ 21 (IIEF-6).
Exclusion criteria
* IIEF \< 21 * Operations in the past 6 months which could limit the erectile function * Erectile dysfunction in the history or current medication for erectile dysfunction * Current involvement in another comparable study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 24 months | Monitoring of side effects and complications in connection with the nerve-implantation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Documented will be the extra time required for the nerve implantation | at the time of operation | 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. |
Countries
Switzerland
Outcome results
None listed