Recruiting

TPLA

Sponsor:

The Cleveland Clinic

Code:

NCT07016620

Conditions

Benign Prostatic Hyperplasia (BPH)

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Transperineal Laser Ablation (TPLA)

Study Details

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Study ID

NCT07016620

Start date

Jan 12, 2026

Status verified date

Feb, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Transperineal Laser Ablation (TPLA)

Patients with recurrent Benign Prostatic Hyperplasia (BPH) after Minimally Invasive Surgical Therapies previous (MIST)

Interventions

Transperineal Laser Ablation (TPLA)

Outpatient treatment with Transperineal Laser Ablation (TPLA) as a salvage therapy after previous Minimally Invasive Surgical Therapies (MIST)

Primary outcome measure

  • Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures [ Time Frame: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation ]

Central Contacts and Locations

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Petar Bajic, MD

216-444-1231bajicp@ccf.org

Raevti Bole, MD

216 445-8640boler@ccf.org

Principal Investigator:

Petar Bajic, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • benign prostatic hyperplasia (BPH)
  • lower urinary tract symptoms (LUTS)
  • transperineal Laser Ablation (TPLA)
  • Minimally Invasive Surgical Therapies (MIST)
  • salvage treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-02-05.