Clinical trial · Interventional
A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery
Prospective Cohort Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post radical prostatectomy nerve restoration procedure (PRP-NR) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Post radical prostatectomy nerve restoration procedure
- description
- A somatic to autonomic nerve grafting procedure which will use a nerve graft of ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side junction between the dorsal penile nerve and the penile corpora cavernosa
- interventionNames
- Procedure: Post radical prostatectomy nerve restoration procedure (PRP-NR)
Primary outcomes (18)
- measure
- International Index of Erectile Function-5 (IIEF-5)
- timeFrame
- 4 weeks post PRP-NR
- description
- The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with persistent post prostatectomy erectile dysfunction as defined below: 1. Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR 2. Moderate ED (IIEF score 8-11) and more than 18 months from prostatectomy * Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function. Exclusion Criteria: * Patients aged \< 18 years at diagnosis * Legally incapable patients * Patients \>5 years from prostatectomy. * Bilateral open inguinal hernia repair * Patients with pre-existing significant neurologic disease * Diabetes with evidence of peripheral nerve involvement and end organ dysfunction * Coronary artery disease with unstable angina * Mood disorder (anxiety/depression) with change in medical therapy within last 3 months * Pre-existing penile base surgery which would prevent grafting technique including suprapubic liposuction, suspensory ligament release * Pre-existing penile prosthesis * Current use of androgen deprivation therapy * Use of medications for chronic nerve pain (gabapentin, amitriptyline, nortriptyline, pregablin) * Previous untreated penile trauma * Patients deemed medically unfit for surgery
References
Publications (0)
Data not yet available