Benign Prostate Hypertrophy(BPH), LUTS(Lower Urinary Tract Symptoms)
Conditions
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).
Interventions
PROCEDUREStandard 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.
PROCEDUREMiLEP
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.
Sponsors
Hospital Pompeia
Sechenov University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of SUI | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of intra- and perioperative adverse events | the day of operation, at 1, 6,12 months post-operative | Assessed using Clavien-Dindo classification system |
| 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 | — |
| Rate of urethral strictures | 6-12 months | — |
| International Prostate Symptom Score (IPSS) | 1 month | Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35) |
| Qmax | 1 month | — |
| PVR | 1 month | — |
| International Index of Erectile Function (IIEF-5) | 1 month | severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25) |
| Hospital stay | participants will be followed for the duration of hospital stay, an expected average of 1,5 days | — |
Countries
Russia
Contacts
Primary ContactVladislav Petov, Associate Professor, urologist
Outcome results
None listed