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A Prospective, Non-Inferiority Trial Comparing Holmium Laser Enucleation of the Prostate (HoLEP) and Robotic-Assisted Simple Prostatectomy (RASP) for Treatment of Benign Prostatic Hyperplasia (BPH) in Large-Volume Prostates

A Prospective, Non-Inferiority Trial Comparing Holmium Laser Enucleation of the Prostate (HoLEP) and Robotic-Assisted Simple Prostatectomy (RASP) for Treatment of Benign Prostatic Hyperplasia (BPH) in Large-Volume Prostates

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109546
Enrollment
Unknown
Registered
2025-09-22
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Benign Prostatic Hyperplasia

Interventions

HoLEP group:None
RASP group:None

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male patients, age >= 50 years old; 2. Prostate adenoma volume >= 120 ml and = 8 and/or Qmax = 100 ml and/or continuous catheterization); 4. Life expectancy >= 5 years; 5. Provide informed consent.

Exclusion criteria

Exclusion criteria: 1. History of previous prostate surgery or pelvic radiotherapy; 2. Suspected risk of prostate cancer not ruled out (patient opted out of further evaluation); 3. Concurrent active urinary tract infection; 4. Presence of non-operable severe cardiopulmonary comorbidities or extremely high anesthesia risk; 5. Uncorrectable coagulation disorders or ongoing anticoagulant therapy; 6. Acontractile bladder or severe bladder dysfunction.

Design outcomes

Primary

MeasureTime frame
The American Urological Association Symptom Score for benign prostatic hyperplasia;

Secondary

MeasureTime frame
Qmax;Post-void residual urine volume;Complications;Sexual and ejaculatory function;Urinary Incontinence;Quality of Life;Reoperation and reintervention rates;operative time;operative blood loss volume;

Countries

China

Contacts

Public ContactXin Ma

Chinese PLA General Hospital

gdhuangqingbo@163.com+86 166 2935 1458

Outcome results

None listed

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