Comparing two laser treatments for enlarged prostate symptoms
Thulium Fiber Laser Compared to Holmium:YAG Laser With Moses Technology for Enucleation of the Prostate: A Prospective Study
NA · Centre hospitalier de l'Université de Montréal (CHUM) · NCT04807296
This study is testing two different laser treatments for men with enlarged prostate to see which one is safer and works better for relieving symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (other) |
| Locations | 1 site (Montréal) |
| Trial ID | NCT04807296 on ClinicalTrials.gov |
What this trial studies
This study compares the safety and clinical outcomes of two laser techniques, thulium fiber laser enucleation of the prostate (TFLEP) and holmium laser enucleation of the prostate with Moses technology (m-HoLEP), in treating benign prostatic hyperplasia (BPH). It aims to evaluate factors such as hospital stay length and blood transfusion needs in patients with BPH and bladder obstruction. The study will follow patients for up to one year post-operatively to assess the effectiveness of each treatment method.
Who should consider this trial
Good fit: Ideal candidates include men with symptomatic benign prostatic hyperplasia who have not responded adequately to previous medical treatments.
Not a fit: Patients with a history of prostate or bladder cancer, neurogenic bladder, or those unfit for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective and safer treatment option for benign prostatic hyperplasia.
How similar studies have performed: While the holmium laser technique is well-established, the thulium fiber laser approach is relatively novel, and this study aims to provide new insights into its effectiveness compared to existing methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with symptomatic benign prostate hyperplasia : urinary retention, acute renal failure (post-renal), refractory hematuria, repeated urinary tract infections, refractory symptoms. * Prostates between 50-300 grams, * IPSS ≥ 8, * Inadequate response to previous medical treatments, * Qmax \< 15 ml/sec and * Providing informed consent Exclusion Criteria: * History of prostatic surgery, * History of prostate or bladder cancer, * Neurogenic bladder, * Urethral stricture, * Anticoagulant therapy (aspirin permitted), not ceased during surgery * Patients unfit for surgery
Where this trial is running
Montréal
- Centre hospitalier de l'Université de Montréal — Montréal, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Benign Prostatic Hyperplasia, Lasers, Solid-State, Lower Urinary Tract Symptoms, Hyperplasia, Urological Manifestations, Prostatic Disease