Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40+
SponsorThe Cleveland Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Indwelling catheter or intermittent catheterization

History of urethral strictures

Previous diagnosis of Prostate cancer

Active UTI or prostatitis

Trial population

Benign Prostatic Hyperplasia (BPH) salvage therapy patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transperineal Laser Ablation (TPLA)

    Procedure/Surgery

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Transperineal Laser Ablation (TPLA)1 intervention

Trial outcomes

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)

Time frame
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

Change in Sexual function as measured by IIEF 6, MSHQ-EjD

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Rocamed Inc

Collaborator