Lower Urinary Tract Symptoms, Prostate Adenoma, Prostatic Hyperplasia, Benign
Conditions
Keywords
laser, HoLEP, ThuLEP, Thulium, Thulium-fiber, BPH, EEP, monopolar enucleation
Brief summary
Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands (\>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes and safety of different techniques of endoscopic enucleation of the prostate (monopolar enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.
Detailed description
HoLEP and ThuLEP or EEP have been approved by the current guidelines of the European Association of Urology for use in men with substantially enlarged prostates (\>80 ml) as first-line therapy \[1\]. This type of operation can be performed by means of several sources of energy. To our knowledge, there were no studies comparing efficacy and complications of these three treatment modalities. In this study the investigators have evaluated efficacy of Thulium-fiber laser enucleation (120 W thulium fiber laser Urolase, IPG IRE-POLUS, Russia with wavelength of 1940 nm) and monopolar enuclation in comparision with HoLEP (VersaPulse Powersuite 100, Lumenis, USA/Israel) in reduction of LUTS secondary to BPH in a prospective randomized trial. All peri-operative parameters, urinary flow parameters, prostate size changes, erectile function and complications associated with the procedures were compared.
Interventions
PROCEDUREThulium-fiber laser enucleation of the prostate
A high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.
PROCEDUREMonopolar enucleation of the prostate
Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.
PROCEDUREHo:YAG laser enucleation of the prostate
Holmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* IPSS\>20; * maximum urinary flow rate\< 10ml\\s (Qmax); * ineffective alfa-blockers therapy.
Exclusion criteria
* histologically verified prostate cancer; * history of prostatic surgery; * urethral strictures; * bladder stones; * chronic urinary retention and cystostomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPSS | Six months | International Prostate Symptom Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL | Six months | Quality of Life Score |
| PVR | Six months | Post-void residual volume |
| Qmax | Six months | Maximal urine flow rate |
| IIEF-5 | Six months | The International Index of Erectile Function |
Outcome results
None listed