Actively Recruiting
Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)
Led by Thunder Bay Regional Health Research Institute · Updated on 2024-08-16
104
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male over 50 years of age at enrollment
- Referred to urology for refractory lower urinary tract symptoms or urinary retention due to BPH
- Medical treatment for BPH has failed
- Prostate size of 80 ml or larger on preoperative ultrasound
- International Prostate Symptom Score (IPSS) over 15 and quality of life score of 3 or more
- Maximum urinary flow rate less than 15 ml/sec
- Provided written informed consent to participate
- Able to follow study procedures
You will not qualify if you...
- Previous surgical treatment for BPH
- History of prostate cancer
- Prostate size smaller than 80 ml
- History or treatment of urethral narrowing (stenosis)
- Known or suspected neurogenic bladder
- Active urinary tract infection until properly treated
- Other medical conditions that may interfere with the study
- Unable to provide informed consent or cannot speak English
AI-Screening
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Trial Site Locations
Total: 1 location
1
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Actively Recruiting
Research Team
R
Rabail Siddiqui, MPH, MHSc
CONTACT
H
Hazem Elmansy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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