IONM During Radical Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1: Prostate cancer patients undergoing surgical treatment in our Hospital 2: Understand the content of this study, actively provide complete and true medical history and examination data, and be willing to cooperate with postoperative interviewers.

3: Voluntarily participate in the study and sign the treatment document within the ethical framework.

Exclusion criteria

1: Histopathology showed that the patient did not have prostate cancer 2: Use a cardiac pacemaker or other electromechanical prosthesis device 3: Suffering from a serious neurological disease, mental illness or other illness that may be life-threatening within two years

Treatment and study plan

IONM

Other

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.

Primary outcomes

IIEF-5

Time frame: 1,3,6 and 12 months after operation

international index of erectile function-5

Study contacts

Contact information is provided by the study sponsor or research team.

Yichun Zheng, Doctor

CONTACT

[email protected]

0571-87783550

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

Intraoperative Neuromonitoring During Radical Prostatectomy

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Apr 30, 2025
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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