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Not yet recruiting NCT06950216

IONM During Radical Prostatectomy

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IONM.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Intraoperative Neuromonitoring During Radical Prostatectomy

Overview

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.

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 o

Primary outcome measures

  • IIEF-5 [Time frame: 1,3,6 and 12 months after operation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06950216 · KY-2025-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗