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Evaluation of the Safety and Efficacy of Blue Laser Surgery versus Holmium Laser Surgery for the Treatment of Benign Prostatic Hyperplasia (>80mL) Patients (Multicenter, Randomized, Parallel Control, Single-blind, Non-inferiority Design)

Evaluation of the Safety and Efficacy of Blue Laser Surgery versus Holmium Laser Surgery for the Treatment of Benign Prostatic Hyperplasia (>80mL) Patients (Multicenter, Randomized, Parallel Control, Single-blind, Non-inferiority Design)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113010
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-11-24
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Benign Prostatic Hyperplasia

Interventions

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Males aged 40–85 years; 2I.PSS>12, Qmax 150 mL); 3.Prostate volume > 80 mL confirmed by ultrasound/MRI; 4.Diagnosed with BPH presenting with lower urinary tract symptoms and scheduled for transurethral prostate laser surgery; 5.Voluntarily participate in the clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients complicated with bladder stones; 2.Subjects with urethral stricture causing difficulty in instrument insertion; 3.Neurogenic lower urinary tract symptoms; 4.Prostate-specific antigen (PSA) levels outside the normal range with inability to rule out prostate cancer; 5.Bladder cancer or other malignant tumors of the urinary system; 6.Patients who have previously undergone BPH or urethral surgery; 7.Severe cardiovascular, pulmonary, or other systemic diseases rendering the patient unable to tolerate surgery; 8.Participation in other clinical trials within three months prior to enrollment; 9.Subjects deemed unsuitable for this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom Score;

Secondary

MeasureTime frame
Quality of life score,QoL;Maximum urinary flow rate (Qmax);Postvoid Residual Urine,PVR;Voided Volume,VV;Operation time, postoperative irrigation time, catheter indwelling time, postoperative hospital stay;Evaluation index of sexual function(IIEF-5, MSHQ-EjD);Overactive Bladder Index (OABSS);Hemoglobin change, transfusion rate;Changes of serum sodium ion;Complications;Quality of surgical recovery score (QoR VAS) at 1 month after surgery;

Countries

China

Contacts

Public ContactNiu Yinong

Beijing Friendship Hospital, Capital Medical University

niuyinong@mail.ccmu.edu.cn+86 186 0102 0160

Outcome results

None listed

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