Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240001
• Other study ID #: RP-775
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Thunder Bay Regional Health Research Institute
• Contact: Rabail Siddiqui, MPH, MHSc
• Phone: (807) 684-6608
• Email: siddiqur[@]tbh.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Thulium Fibre Laser
Participants will undergo treatment using the TFL
• MOSES Holmium Laser
Participants will undergo treatment using the MOSES Holmium laser.

Locations

Country	Name	City	State
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Thunder Bay Regional Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in the hospital		within 6 hours
Secondary	Incidence of bleeding		Intra-Op
Secondary	Incidence of blood transfusion		Intra-Op
Secondary	Operative time	Including laser use time	Intra-Op
Secondary	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
Secondary	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
Secondary	Peak flow rate	Qmax	1,3,6,12 months post-op
Secondary	Post-void residual	PVR	1,3,6,12 months post-op
Secondary	Prostate specific antigen	PSA	1,3,6,12 months post-op
Secondary	Change in size	Assessed by TRUS	6 months
Secondary	Time to Catheter Removal		within 4 hours