Transperineal laser ablation to treat persistent obstruction from BPH after minimally invasive procedures
Official title: In-Office Transperineal Laser Ablation (TPLA) as a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia (BPH) After Minimally Invasive Surgical Therapies (MIST)
Run by The Cleveland Clinic · NCT07016620 · Data updated 2026-11-12
This test will try in-office transperineal laser ablation (TPLA) to relieve urinary blockage and symptoms in men whose BPH returned after prior minimally invasive treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years and up |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07016620 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men over 40 with recurrent obstructive LUTS after a minimally invasive BPH procedure within five years, prostate volume 30–80 g, IPSS ≥12, PVR >150 cc or reduced flow, PSA screening negative for cancer (or worked-up if 4–10), and preserved erectile function (IIEF-6 ≥10) are ideal candidates.
✕Probably not a fit
Patients with prior traditional prostate surgery (e.g., TURP, HOLEP), prostate cancer, indwelling catheter use, neurogenic bladder, active infection, urethral stricture, or poor detrusor function are unlikely to benefit from TPLA in this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will offer in-office TPLA using the Echolaser system to men with recurrent obstructive lower urinary tract symptoms after prior minimally invasive BPH procedures. Outcomes will include objective urodynamic measures (Qmax, post-void residual), symptom scores (IPSS), sexual function (IIEF-6, MSHQ-EjD), and complication rates with follow-up out to 12 months. Eligible participants are men over 40 with prior MIST within five years, prostate volume 30–80 g, IPSS ≥12, and evidence of obstruction or high PVR. The Cleveland Clinic, which treats a high volume of BPH salvage cases, will perform the procedures and follow-up assessments.
Why it matters
Potential benefit: If successful, TPLA could relieve obstruction and urinary symptoms while avoiding more invasive surgery such as TURP.
How similar studies have gone: Early pilot studies and a recent systematic review of six studies reported consistent improvements in Qmax, PVR, and IPSS with low complication rates and generally preserved sexual function, though randomized comparative data remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Cleveland Clinic
Cleveland, Ohio, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.