Comparing MiLEP and standard EEP for treating prostate enlargement
The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate
This study is testing a new method called MiLEP against the standard treatment for prostate enlargement to see which one works better for men with urinary problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | Sechenov University Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06839768 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of MiLEP, a modified endoscopic technique using smaller instruments, against the standard endoscopic enucleation of the prostate (EEP) for patients with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). The study will utilize a thulium fiber laser for both procedures and assess outcomes such as rates of stress urinary incontinence and urethral strictures. Participants will be selected based on specific criteria related to their urinary symptoms and prostate health.
Who should consider this trial
Good fit: Ideal candidates for this study are men experiencing significant lower urinary tract symptoms due to benign prostatic hyperplasia.
Not a fit: Patients with prostate cancer, prior prostate surgeries, or significant prostate enlargement (over 120 cc) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with BPH, potentially reducing complications associated with standard procedures.
How similar studies have performed: While the approach of using smaller instruments in endoscopic procedures is gaining interest, the specific comparison of MiLEP to standard EEP is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: LUTS presence, proven by: 1. IPSS questionnaire (Score \>20); 2. OR uroflowmetry result (Qmax \<10 ml/s); Exclusion Criteria: * Prostate volume \> 120 cc * Prostate cancer on pathology; * Urethral strictures; * Bladder calculi; * Prior prostate surgery; * Neurogenic bladder dysfunction.
Where this trial is running
Moscow
- Institute for Urology and Reproductive Health, Sechenov University — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Vladislav Petov, Associate Professor, urologist
- Email: pettow@mail.ru
- Phone: +7 925 351 75 49
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.