Clinical trial NCT05240001: Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)
Official title: Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser Enucleation of the Prostate for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Thunder Bay Regional Health Research Institute
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 104
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of stay in the hospital
timeFrame: within 6 hours
Secondary outcomes:
measure: Incidence of bleeding
timeFrame: Intra-Op
measure: Incidence of blood transfusion
timeFrame: Intra-Op
measure: Operative time
timeFrame: Intra-Op
measure: International Prostate Symptom Score
timeFrame: 1,3,6,12 months post-op
measure: Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)
timeFrame: 1,3,6,12 months post-op
measure: Peak flow rate
timeFrame: 1,3,6,12 months post-op
measure: Post-void residual
timeFrame: 1,3,6,12 months post-op
measure: Prostate specific antigen
timeFrame: 1,3,6,12 months post-op
measure: Change in size
timeFrame: 6 months
measure: Time to Catheter Removal
timeFrame: within 4 hours
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
Study officials:
affiliation: Thunder Bay Regional Health Sciences Centre
name: Hazem Elmansy, MD
role: PRINCIPAL_INVESTIGATOR
References: