NCT07016620 Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
| NCT ID | NCT07016620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Benign Prostatic Hyperplasia (BPH) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-01-12 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Benign prostatic hyperplasia (BPH) is a common condition affecting aging men, often leading to lower urinary tract symptoms (LUTS). While Minimally Invasive Surgical Therapies (MIST) procedures offer less invasive alternatives to traditional surgery, some patients experience symptom recurrence or require further intervention due to lack of adequate relief of obstruction. Treatment of persistent obstruction after MIST therapy (BPH salvage therapy) typically requires surgical intervention like transurethral resection of prostate (TURP). This study proposes to evaluate the effectiveness of in-office transperineal laser ablation (TPLA) using the Echolaser system as a minimally invasive treatment option for these patients, potentially avoiding more invasive surgical procedures. The Cleveland Clinic sees a high volume of BPH salvage patients, making this an ideal setting for this research.
Eligibility Criteria
Inclusion Criteria: * Men \> 40 years old * History of Minimally invasive BPH procedure within the last 5 years. * IPSS \>= 12 * Prostate Volume 30 - 80 gr as assessed by CT, MRI or TRUS. * PSA \<4 or for patients with PSA 4-10 evaluation has been performed to rule out prostate cancer using biopsy, MRI, biomarker, or surgeon judgement. Labs within 1 year of study initiation * PVR \> 150cc or reduced flow on uroflow likely due to obstruction based on clinical judgement * IIEF-6\>or =10 without medication Exclusion Criteria: * Indwelling catheter or intermittent catheterization * History of urethral strictures * Previous diagnosis of Prostate cancer * Active UTI or prostatitis * Hypoactive detrusor function * Neurogenic bladder (secondary to stroke, Multiple Sclerosis, Parkinson's disease, Spinal cord injury) * Ejaculatory dysfunction (retrograde ejaculation, anorgasmia or anejaculation) * Prior traditional BPH surgery (TURP, PVP, Aquablation, HOLEP, SP) * Presence of obstructive median lobe * Moderate to severe or severe ED based on IIEF-6/SHIM (SHIM of 10) * Peyronie's disease
Frequently Asked Questions
Who can join the NCT07016620 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Benign Prostatic Hyperplasia (BPH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07016620 currently recruiting?
Yes, NCT07016620 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Cleveland Clinic to inquire about joining.
Where is the NCT07016620 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07016620 clinical trial?
NCT07016620 is sponsored by The Cleveland Clinic. The trial plans to enroll 20 participants.