Skip to content

IONM During Radical Prostatectomy

Intraoperative Neuromonitoring During Radical Prostatectomy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06950216
Enrollment
40
Registered
2025-04-30
Start date
2025-04-30
Completion date
2026-06-30
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Intraoperative neuromonitoring, Urinary incontinence, Erectile dysfunction

Brief 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.

Interventions

OTHERIONM

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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IIEF-51,3,6 and 12 months after operationinternational index of erectile function-5

Contacts

Primary ContactYichun Zheng, Doctor
2101090@zju.edu.cn0571-87783550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026