Non-inferiority of Low Power to High Power Holmium Laser Enucleation of the Prostate in BPH
Introduction
The American Urological Association (AUA) and European Association of Urology (EAU) guidelines have supported the use of transurethral Holmium Laser Enucleation of the Prostate (HoLEP) in the management of benign prostatic hyperplasia (BPH). However, high initial cost has been limiting the widespread adoption of this procedure. Use of low power HoLEP (LP-HoLEP) with the similar enucleation efficiency as high power HoLEP (HP-HoLEP) could reduce the cost burden, enabling its widespread use.
Aim
To evaluate the non-inferiority of LP-HoLEP to HP-HoLEP in achieving similar enucleation efficiency with the advantages of lower cost, minimal postoperative dysuria, storage symptoms and negative sexual impact.
Patient Profile
- Patients with refractory lower urinary tract symptoms (LUTS) secondary to BPH
- Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment
Method
Study Design
Randomized controlled trial.
Treatment Strategy
- The cohort underwent the following assessments at baseline
- Urinary symptoms using International Prostate Symptom Score (IPSS)
- Quality of life (QOL)
- Uroflow and postvoid residual urine (PVR)
- Prostate specific antigen (PSA)
- Transrectal ultrasound (TRUS)
- Preoperative erectile function (EF) using SHIM score (sexual health inventory for men)
- HoLEP was performed with laser-assisted enucleation of prostate according to the morphology
- 61 patients underwent LP-HoLEP (2J and 25 Hz) and HP-HoLEP was performed in 60 (2J and 50 Hz)
- 2 surgeons with different experience performed equal number of both procedures
Endpoints
Primary Endpoint
- Enucleation efficiency calculated as resected prostate weight divided by enucleation time in gm/min
Secondary Endpoints
- Operative efficiency, calculated as resected prostate weight divided by operative time in gm/min
- Morcellation efficiency, calculated as resected prostate weight divided by morcellation time in gm/min
- L/P ratio – laser energy consumed divided by resected prostate weight in KJ/gm
- Laser rate – laser energy consumed divided by enucleation time in KJ/min
- Volume of intraoperative irrigation in liters
- Perioperative blood loss
- Days of hospitalization
- Postoperative dysuria using dysuria visual analogue scale (DVAS)
- Perioperative complications
- IPSS, QOL, Q-max (peak urine flow rate) and PVR at 1, 4 and 12 months postoperatively
- PSA level at 4 and 12 months
- % change of mean postoperative PSA
- EF changes at 4 and 12 months
Results
- Both the groups had similar baseline and perioperative parameters
- The comparison of enucleation efficacy and other endpoints are as seen in table 1.
|
Endpoint |
LP-HoLEP |
HP-HoLEP |
p value |
|
Mean enucleation efficiency (gm/min) |
1.42+0.6NR |
1.47+0.6 |
0.6 |
|
Mean morcellation efficiency (gm/min) |
5.41+2.2 |
6.02+2.8 |
0.19 |
|
Median L/P ratio |
1.59 |
1.6 |
0.44 |
|
Median laser rate (KJ/gm) |
2.1 |
2.4 |
0.03 |
|
Mean volume of intraoperative irrigation (liters) |
42.8+15 |
41.4+19 |
0.6 |
|
Median hospital stay in days |
1 |
1 |
0.052 |
|
Postoperative dysuria (DVAS score) |
2 |
3 |
0.45 |
|
Median IPSS at year 1 |
3 |
4 |
0.4 |
|
Meadian QOL at year 1 |
1 |
1 |
0.6 |
|
Median Qmax at year 1 |
21.1 |
21.8 |
0.7 |
|
Median PVR at year 1 |
29 |
22 |
0.09 |
|
Stress urinary incontinence (%) |
6.5% |
8.3% |
0.6 |
|
Median postoperative reduction of PSA |
89% |
81% |
0.92 |
|
Mean SHIM score at year 1 |
22+2.3 |
21+1.4 |
|
Conclusion
- LP-HoLEP was non-inferior to HP-HoLEP with respect to all operative efficiency parameters, irrespective of the level of experience of the surgeons
- The efficiency outcomes of HoLEP was maintained across the different follow up points irrespective of the used laser power.
Urology 2018. Doi: 10.1016/j.urology.2018.07.010.
