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IONM During Radical Prostatectomy

T

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status

Not yet enrolling

Conditions

Prostate Cancer

Treatments

Other: IONM

Study type

Interventional

Funder types

Other

Identifiers

NCT06950216
KY-2025-007

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 2 patient groups

IONM group
Experimental group
Description:
IONM was performed during the operation.
Treatment:
Other: IONM
control group
No Intervention group
Description:
No IONM

Trial contacts and locations

0

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Central trial contact

Yichun Zheng, Doctor

Data sourced from clinicaltrials.gov

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