Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

NCT07016620 | Recruiting

• 1 other identifier: 25-327
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures

  Change in Urinary Function as measured with IPSS score, Uroflow variables (Qmax) and Post void residue (PVR)

  baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation

Secondary Outcomes (1)

• Evaluate the effect of TPLA on erectile function & ejaculatory functions in this patient population

  baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation

Study Arms (1)

Transperineal Laser Ablation (TPLA)

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

Procedure: Transperineal Laser Ablation (TPLA)

Interventions

Transperineal Laser Ablation (TPLA) PROCEDURE

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

Transperineal Laser Ablation (TPLA)

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Benign Prostatic Hyperplasia (BPH) only occurs in men
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Benign Prostatic Hyperplasia (BPH) salvage therapy patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Rocamed Inc: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (4)

• Sessa F, Bisegna C, Polverino P, Gacci M, Siena G, Cocci A, Li Marzi V, Minervini A, Serni S, Campi R. Transperineal laser ablation of the prostate (TPLA) for selected patients with lower urinary tract symptoms due to benign prostatic obstruction: a step-by-step guide. Urol Video J. 2022;15:100167. doi:10.1016/j.urolvj.2022.100167.

  BACKGROUND

• Tafuri A, Panunzio A, De Carlo F, Luperto E, Di Cosmo F, Cavaliere A, Rizzo M, Tian Z, Shakir A, De Mitri R, Porcaro AB, Cerruto MA, Antonelli A, Cormio L, Carrieri G, Karakiewicz PI, Abreu AL, Pagliarulo V. Transperineal Laser Ablation for Benign Prostatic Enlargement: A Systematic Review and Pooled Analysis of Pilot Studies. J Clin Med. 2023 Feb 26;12(5):1860. doi: 10.3390/jcm12051860.

  PMID: 36902647 RESULT

• de Rienzo G, Lorusso A, Minafra P, Zingarelli M, Papapicco G, Lucarelli G, Battaglia M, Ditonno P. Transperineal interstitial laser ablation of the prostate, a novel option for minimally invasive treatment of benign prostatic obstruction. Eur Urol. 2021 Jul;80(1):95-103. doi: 10.1016/j.eururo.2020.08.018. Epub 2020 Aug 28.

  PMID: 32868137 RESULT

• Manenti G, Perretta T, Calcagni A, Ferrari D, Ryan CP, Fraioli F, Meucci R, Malizia A, Iacovelli V, Agro EF, Floris R. 3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. Eur Radiol Exp. 2021 Sep 17;5(1):41. doi: 10.1186/s41747-021-00239-9.

  PMID: 34532768 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: June 11, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)