An interventional study of Standard endoscopic enucleation of the prostate (EEP) and MiLEP in Benign Prostate Hypertrophy(BPH) and LUTS(Lower Urinary Tract Symptoms), sponsored by Sechenov University. Recruiting at 1 site in Russian Federation. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Sechenov University · Not applicable, Interventional, and Treatment
Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.
Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 340 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Sechenov University is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
LUTS presence, proven by:
Exclusion Criteria:
Procedure: MiLEP
Procedure: Standard endoscopic enucleation of the prostate (EEP)
Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.
Minimally-invasive laser EEP will be nerformed using 22 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.
The rate of SUI
Time frame: 1 month
Rate of urethral strictures
Time frame: 6-12 months
Rate of intra- and perioperative adverse events
Assessed using Clavien-Dindo classification system
Time frame: the day of operation, at 1, 6,12 months post-operative
Operative time
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
Blood loss (blood levels of haemoglobin and haematocrit)
Time frame: 1 day before and 1 day after surgery
Catheterization time
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
International Prostate Symptom Score (IPSS)
Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35)
Time frame: 1 month
Qmax
Time frame: 1 month
PVR
Time frame: 1 month
International Index of Erectile Function (IIEF-5)
severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25)
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sechenov University