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IONM During Radical Prostatectomy

NCT06950216 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-30

No results posted yet for this study

Summary

At present, the preferred treatment for patients with prostate cancer is still radical prostatectomy. Postoperative patients often face some complications, the most common complications include urinary incontinence and erectile dysfunction. Urinary incontinence is caused by intraoperative injury of urinary control nerves or muscles. Erectile dysfunction is related to intraoperative injury of nerves that control erection. Therefore, intraoperative nerve preservation is a key measure to reduce postoperative complications, especially to prevent erectile dysfunction. This study intends to improve the nerve-sparing radical prostatectomy by monitoring the nerve during radical prostatectomy, locating the cavernous nerve and other related nerves, in order to reduce the incidence of postoperative complications such as erectile dysfunction.

Conditions

Interventions

OTHER

IONM

The probe needle electrodes were inserted into the corpus cavernosum penis, ischiocavernosus muscle, bulbocavernosus muscle, anal sphincter, etc., and each monitoring electrode was connected to the nerve monitor. The changes of electromyography of each effector during the operation were monitored in real time. The stimulation electrode was placed in the abdominal cavity during the operation. During the resection of the prostate, electrical stimulation was performed on the possible running area of the NVB, and the stimulation site where the signal was monitored was protected from resection and burning under the premise of safe surgery.

Sponsors & Collaborators

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    lead OTHER

Principal Investigators

  • Yichun Zheng, Doctor · The Fourth Affiliated Hospital Zhejiang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06950216 on ClinicalTrials.gov