NCT06839768RecruitingNot Applicable
The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate
Sechenov University1 site in 1 country340 target enrollmentStarted: March 14, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- The rate of SUI
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •LUTS presence, proven by:
- •IPSS questionnaire (Score >20);
- •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.
Arms & Interventions
EEP (26 Ch)
Active Comparator
Intervention: Standard endoscopic enucleation of the prostate (EEP) (Procedure)
MiLEP (22 Ch)
Experimental
Intervention: MiLEP (Procedure)
Outcomes
Primary Outcomes
The rate of SUI
Time Frame: 1 month
Secondary Outcomes
- Rate of urethral strictures(6-12 months)
- Hospital stay(participants will be followed for the duration of hospital stay, an expected average of 1,5 days)
- Rate of intra- and perioperative adverse events(the day of operation, at 1, 6,12 months post-operative)
- Operative time(participants will be followed for the duration of the intervention, an expected average of 1 hour)
- Blood loss (blood levels of haemoglobin and haematocrit)(1 day before and 1 day after surgery)
- Catheterization time(participants will be followed for the duration of hospital stay, an expected average of 1,5 days)
- Qmax(1 month)
- International Prostate Symptom Score (IPSS)(1 month)
- PVR(1 month)
- International Index of Erectile Function (IIEF-5)(1 month)
Investigators
Vladislav Petov
Assosiate Professor, urologist
Sechenov University
Study Sites (1)
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