Assessing the learning curve of a prostate laser surgery technique
The Learning Curve of Transurethral Holmium Laser Enucleation of the Prostate, Multicenter Prospective Assessment Through a Novel Technique
This study is testing how quickly new doctors can learn a special laser surgery for treating an enlarged prostate to make the procedure safer and more efficient.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Mansoura, DK) |
| Trial ID | NCT06038890 on ClinicalTrials.gov |
What this trial studies
This study evaluates the learning curve associated with the veil-sparing technique of Holmium laser enucleation of the prostate (HoLEP) for treating benign prostate hyperplasia. It involves a prospective multicenter assessment where new learners will perform the procedure, and their learning outcomes will be measured against the number of cases performed over time. The goal is to determine how quickly new practitioners can achieve proficiency and improve safety and efficiency in the procedure. By standardizing the learning protocol, the study aims to facilitate wider adoption of this effective surgical technique.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with prostate volumes of 40 cc or more who require transurethral surgery for benign prostatic obstruction.
Not a fit: Patients with mild symptoms (IPSS < 13), high urinary flow rates (Qmax > 15 mL/s), or those with prostate cancer or previous prostate surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved training protocols, enabling more urologists to perform HoLEP safely and effectively.
How similar studies have performed: Previous studies have shown success with similar approaches in improving surgical techniques, but this specific assessment of the learning curve using the veil-sparing technique is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with prostate volume (≥40 cc) who are indicated for transurethral surgery for the BPO. Exclusion Criteria: * Patients with IPSS \<13. * Patients with Qmax \>15 mL/s. * Presence of urethral stricture. * Patients with neurogenic bladder. * Patients with prostate cancer. * Patients with previous prostate surgery.
Where this trial is running
Mansoura, DK
- Urology and nephrology center — Mansoura, Dk, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.