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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 MOSESâ„¢ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Patients randomized to this arm will undergo treatment using the TFL. |
|
| MOSES Holmium Laser | Experimental | Patients randomized to this arm will undergo treatment using the MOSES Holmium laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thulium Fibre Laser | Device | Participants will undergo treatment using the TFL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in the hospital | within 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bleeding | Intra-Op | |
| Incidence of blood transfusion | Intra-Op | |
| Operative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rabail Siddiqui, MPH, MHSc | Contact | (807) 684-6608 | siddiqur@tbh.net | |
| Hazem Elmansy, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Hazem Elmansy, MD | Thunder Bay Regional Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thunder Bay Regional Health Sciences Centre | Recruiting | Thunder Bay | Ontario | P7B 6V4 | Canada |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| MOSES Holmium Laser | Device | Participants will undergo treatment using the MOSES Holmium laser. |
|
Including laser use time
| Intra-Op |
| International Prostate Symptom Score | 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. | 1,3,6,12 months post-op |
| Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS) | 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'. | 1,3,6,12 months post-op |
| Peak flow rate | Qmax | 1,3,6,12 months post-op |
| Post-void residual | PVR | 1,3,6,12 months post-op |
| Prostate specific antigen | PSA | 1,3,6,12 months post-op |
| Change in size | Assessed by TRUS | 6 months |
| Time to Catheter Removal | within 4 hours |
| D052801 |
| Male Urogenital Diseases |