Benign Prostatic Hyperplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males aged 40–85 years; 2. IPSS>12, Qmax <=15 mL/s; 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
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Score;Maximum Urinary Flow Rate;Postvoid Residual Urine;Voided Volume;Duration of operative time;postoperative irrigation duration;catheter indwelling time;postoperative hospital stay;Sexual function evaluation indicators;Overactive Bladder Symptom Score;Hemoglobin change;transfusion rate;Serum sodium ion change;Complications;Quality of Recovery Visual Analogue Scale; | — |
Countries
China
Contacts
Beijing Friendship Hospital, Capital Medical University