(026) Phase I Clinical Trial: Pilot Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy
Bibliographic record
Abstract
Abstract Introduction Despite advances in surgical technique, erectile dysfunction (ED) remains a significant and distressing complication of radical prostatectomy. Attempts to preserve erectile function through nerve-sparing approaches are often limited by the need to balance functional outcomes with oncological safety. Recent studies have shown promising results using somatic-to-autonomic nerve grafting for patients with persistent ED beyond two years post-prostatectomy. However, these approaches have been limited by procedural complexity and the requirement for close collaboration between urologists and plastic surgeons. Objective This single-arm, prospective Phase I trial aims to evaluate the safety and feasibility of a novel somatic-to-autonomic nerve grafting technique for the restoration of erectile function in men with persistent ED following radical prostatectomy. Erectile function recovery is also being tracked as a secondary outcome. Methods Ten patients with normal preoperative erectile function and persistent ED for more than 18 months post-prostatectomy were enrolled. A novel bilateral end-to-side neurorrhaphy was performed between the dorsal penile nerve and the corpora cavernosa using an ilioinguinal nerve graft harvested from the inguinal canal. Baseline assessments included the International Index of Erectile Function-5 (IIEF-5) and our institution’s validated short-form pain questionnaire. Postoperative evaluations are scheduled at 4 weeks, and at 3, 6, 12, 18, and 24 months. Safety is assessed through documentation of any perioperative or postoperative complications. Data collection includes demographics, perioperative outcomes, and both primary (safety/feasibility) and secondary (erectile function) endpoints. Results Ten patients with a mean age of 63.1 years (SD ± 6.6) were enrolled. The average pre-prostatectomy IIEF-5 score was 24.7/25, which decreased to 5/25 post-prostatectomy. The mean time from prostatectomy to nerve grafting was 32.3 months (SD ± 12.3), with an average operative time of 79.4 minutes (SD ± 18.7). Postoperative incisional pain was effectively managed with standard analgesics. Six patients reported mild, non-bothersome numbness of the ipsilateral hemiscrotum. At the 4-week follow-up, all patients reported a pain score of 0/5. One patient developed a Clavien-Dindo Grade II complication (one wound infection requiring antibiotics), while two patients had a Clavien Dindo Grade I hematoma which resolved without intervention. At the time of abstract submission, patients had been followed for an average of 3.63 months (SD ± 2.3), with seven having reached >2 months post-surgery. Among these, the mean IIEF-5 score was 13.7 (SD ± 5.1), and three patients had achieved penetrative intercourse. Conclusions Preliminary findings from this ongoing Phase I trial suggest that bilateral end-to-side neurorrhaphy using an ilioinguinal nerve graft is a feasible and safe approach, associated with minimal morbidity. Early data on erectile function recovery are promising, showing meaningful improvements from baseline. This technique may offer a novel therapeutic avenue for post-prostatectomy ED and warrants further investigation in larger trials. Disclosure No
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".