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Evaluation of the effect of intraoperative neuromonitoring in radical prostatectomy: a prospective, case-control clinical study

Evaluation of the effect of intraoperative neuromonitoring in radical prostatectomy: a prospective, case-control clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091738
Enrollment
Unknown
Registered
2024-11-01
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

prostate cancer

Interventions

experimental group:Intraoperatively, after anesthesia, the collection device is arranged. As shown in the figure below, two double-stranded subcutaneous needles are inserted parallel into the cavernou
control group:The surgical procedure is the same as in the experimental group. During the surgery, the conventional method of visual identification by the surgeon's naked eye will be used to confirm t

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Males aged between 18 and 75 years; (2) Those with pathologically confirmed localized prostate cancer (clinical stage =T2cN0M0); (3) Defined as low risk according to the NCCN 2020 Prostate Cancer Guidelines (Gleason score =7); (4) International Index of Erectile Function-5 (IIEF-5) score of 18 or higher; (5) Normal erectile function before surgery; (6) Signed an informed consent form; (7) Those who have not undergone neoadjuvant endocrine therapy.

Exclusion criteria

Exclusion criteria: (1) Those with preoperative erectile dysfunction; (2) Those with a cardiac pacemaker or who have undergone other electrophysiological treatments; (3) Those with a history of abdominal or pelvic surgery or radiation therapy, or who have undergone transurethral resection of the prostate; (4) Those with central or peripheral nervous system disorders; (5) Those with severe underlying diseases, such as arrhythmias, heart failure, severe pulmonary insufficiency, etc.; (6) Those with severe anxiety, depression, mania, or psychiatric diseases, who are unable to cooperate with treatment and follow-up; (7) Those with a history of other malignant tumors; (8) Those with a severe allergic constitution; (9) Those whom the researcher considers unsuitable for participation for other reasons; (10) Those who require adjuvant endocrine therapy.

Design outcomes

Primary

MeasureTime frame
IIEF-5 score;

Secondary

MeasureTime frame
Positive Surgical Margin Rate (PSA Level).;Surgical Time;Intraoperative Blood Loss;Hospital Stay Duration;Perioperative Complications;Instrument Performance Evaluation;

Countries

china

Contacts

Public ContactYao Lin

Peking University First Hospital

poparies@163.com+86 138 1034 5670

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026