Evaluation of the Application Effect of a Surgical Navigation System in HoLEP Surgery

NCT07251621 | Completed

• 1 other identifier: S202403101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

3D imaging-assisted surgical navigation system was established using the following specific procedures: 1) Prostate MRI Acquisition and 3D Reconstruction: patient prostate MRI images are acquired, and professional engineers complete 3D reconstruction; 2) Data Import to Diagnostic Ultrasound System: Reconstructed prostate MRI images and P-3DRI (Prostate 3D Reconstruction Image) data are imported into the Diagnostic Ultrasound system; 3) Transrectal Ultrasound Probe Placement: The transrectal ultrasound probe is secured to a dedicated holder. The probe is inserted into the patient's rectum to locate the prostate. After manual adjustment to optimize imaging, the holder is fixed in position; 4) Initial Position Registration: The Diagnostic Ultrasound system integrates prostate MRI, P-3DRI, and real-time ultrasound images. Spatial correspondence between P-3DRI and the actual prostate position is established using real-time ultrasound; 5) Cystoscope-Electromagnetic Navigation Assembly: A self-designed electromagnetic navigation connector links the electromagnetic sensor to the cystoscope. The ultrasound probe is simultaneously equipped with an electromagnetic sensor; 6) Real-time Spatial Tracking and Fusion: The electromagnetic navigation module tracks spatial positions of surgical instruments and the ultrasound probe. These positions are fused with real-time ultrasound coordinates. Through the above steps, the relative position between surgical instruments and the prostate is displayed in real time, achieving intraoperative navigation. All procedures were performed by the same Associate Chief Physician at our medical center. Based on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group.

Conditions

Benign Prostate Hypertrophy(BPH)

Keywords

Benign Prostate Hypertrophy; holmium laser enucleation of the prostate; Surgical Navigation System

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  Urinary Incontinence (Defined as an International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score ≥ 1), Urethral Stricture (Defined as recurrence of dysuria or narrowed urine stream postoperatively, confirmed by cystoscopy)

  month 1；month 3；

Study Arms (1)

use of the 3D imaging-assisted surgical navigation system during surgery

EXPERIMENTAL

Based on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group

Procedure: use the 3D imaging-assisted surgical navigation system during surgery

Interventions

use the 3D imaging-assisted surgical navigation system during surgery PROCEDURE

Based on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group.

use of the 3D imaging-assisted surgical navigation system during surgery

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Clinically diagnosed BPH patients with LUTS; 2) Voluntarily participated in the clinical trial and provided written informed consent; 3) Met the surgical intervention indications outlined in the 2019 'Chinese Guidelines for Diagnosis and Treatment of Urological Diseases'; 4) Completed preoperative BPH evaluations, including International Prostate Symptom Score (IPSS) and Quality of Life (QoL) assessment.

You may not qualify if:

• \) Refusal to participate in the clinical trial; 2) Presence of severe uncontrolled medical conditions or psychiatric disorders; 3) Cognitive impairment impeding normal communication.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

ChinaPLAGH

Beijing, Haidian, 100039, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: April 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)