Enlarged Prostate (BPH) Clinical Trials

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In-Office Transperineal Laser Ablation (TPLA) as a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia (BPH) After Minimally Invasive Surgical Therapies (MIST)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 40
View:

• 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

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 20
Treatments
Transperineal Laser Ablation (TPLA)
Patients with recurrent Benign Prostatic Hyperplasia (BPH) after Minimally Invasive Surgical Therapies previous (MIST)
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic
Collaborators: Rocamed Inc

This content was sourced from clinicaltrials.gov