Benign Prostatic Hyperplasia
Conditions
Brief summary
Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion and late postoperative bleeding. Holmium laser enucleation of the prostate (HoLEP) is a safe and effective procedure which has demonstrated comparable results to TURP. HOLEP also offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. The main reason HoLEP has yet to become the new standard for treatment of symptomatic BPH is due the complexity of this procedure as compared to TURP. Furthermore, the HoLEP can be used with the MOSESTM system, a system that allows for more efficiency and ease of use of the HoLEP. Thulium fiber laser (TFL) enucleation of the prostate is an emerging technology for endoscopic prostate enucleation that is notable for its high wavelength and pulsed mode of action. Recent studies have shown TFL enucleation of the prostate to be a safe and highly efficacious treatment modality for the management of large volume (\> 80 cm3) glands in BPH. Due to its novelty, further studies are needed to broaden the investigators' understanding of the TFL and comprehend the full implications and benefits of this new technology, as well its limitations. The aim of this study is to whether Thulium Fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation using MOSES™ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.
Interventions
DEVICEThulium Fibre Laser
Participants will undergo treatment using the TFL
DEVICEMOSES Holmium Laser
Participants will undergo treatment using the MOSES Holmium laser.
Sponsors
Thunder Bay Regional Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males over 50 years of age at the time of enrollment 2. Referred to urology for refractory LUTS or urinary retention secondary to BPH 3. Failed medical (non-surgical) treatment 4. Prostate size on preoperative TRUS of≥80 ml 5. IPSS \>15 and QOL score ≥3 and Qmax \<15 ml/sec 6. Written informed consent to participate in the study 7. Ability to comply with the requirements of the study procedures
Exclusion criteria
1. Previous surgical treatment for BPH 2. History of prostate cancer 3. Prostate size \< 80 mL 4. History of urethral stenosis or its management 5. Known or suspected neurogenic bladder 6. Participants with active urinary tract infection until appropriately treated 7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study 8. Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of stay in the hospital | within 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of blood transfusion | Intra-Op | — |
| Operative time | Intra-Op | Including laser use time |
| International Prostate Symptom Score | 1,3,6,12 months post-op | Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35. |
| Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS) | 1,3,6,12 months post-op | Response to the last question on the IPSS: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response ranging from 'Delighted' to 'Terrible'. |
| Incidence of bleeding | Intra-Op | — |
| Post-void residual | 1,3,6,12 months post-op | PVR |
| Prostate specific antigen | 1,3,6,12 months post-op | PSA |
| Change in size | 6 months | Assessed by TRUS |
| Time to Catheter Removal | within 4 hours | — |
| Peak flow rate | 1,3,6,12 months post-op | Qmax |
Countries
Canada
Contacts
Primary ContactRabail Siddiqui, MPH, MHSc
Backup ContactHazem Elmansy, MD
Outcome results
None listed