Comparing MiLEP and standard EEP for treating prostate enlargement
Official title: The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate
Run by Sechenov University · NCT06839768 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | Men only |
| Enrollment | 340 (estimated) |
| Sponsor | Sechenov University Academic / other |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | March 14, 2024 |
| Main results expected | March 2025 |
| Study ends | May 2025 |
| Registry record updated | February 21, 2025 |
| Trial ID | NCT06839768 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are men experiencing significant lower urinary tract symptoms due to benign prostatic hyperplasia.
✕Probably not a fit
Patients with prostate cancer, prior prostate surgeries, or significant prostate enlargement (over 120 cc) may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.