Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA

Status unconfirmed · Phase 1

Conditions studied: Male Urogenital Diseases, Genital Diseases, Male, Prostatic Disease, Prostatic Hyperplasia

In brief

This study is set up as a phase I-II prospective, single center, interventional pilot study carried in Office setting under local anesthesia. It will assess the impact in quality of life and adverse events produced by transperineal laser ablation of the prostate (TPLA) in men 40 to 85 years of age with benign prostatic hypertrophy (BPH). BPH is currently managed with medications (ie, alpha-1 adrenergic medications) and/or invasive approaches such as transurethral resection of prostate or surgical excision of prostate - robotic or open lead to relaxation or excision of the bladder neck. Such alteration of the bladder neck function or anatomy portends a significant and noticeable change on a male lifestyle, represented by absence of antegrade ejaculation among others. This study aims to evaluate the use of TPLA in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk. Moreover, it aims to determine safety profile and outcomes from TPLA therapy The fundamental objective is to determine the feasibility and safety of TPLA in healthy men with LUTS due to BPH, successful performed in the outpatient office-based setting under local anesthesia. Secondary objectives include: 1-Uroflowmetry and Patient Reported Outcome Measures (PROMs) at three, six and 12 months; 2-Immediately spontaneous voiding post-TPLA; 3-Hematuria incidence after TPLA, measured by patient reporting; 4-LUTS after the treatment measured by IPSS; 5- Erectile function and presence of ejaculation after TPLA treatment and 6-Prostate volume changes using Transrectal ultrasound (TRUS) volume measurements

Key facts

Study ID: NCT04760483
Run by: Urological Research Network, LLC
People needed: 20
Starts: 2020-11-20
Expected to finish: 2026-03-20
Last updated by the study team: 2023-01-26

Who can join

Age: 40 and older, up to 85. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Presence of Lower Urinary Tract Symptoms (LUTS) measure by International Prostate Symptom Scores (IPSS) greater than 9
Serum creatinine levels <1.5 ng/dl and GFR > 55
Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry, pressure flow studies or urodynamic investigation
Post-void residual (PVR): ≤ 250 mL
Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound
Signed informed consent

You may not qualify if…

Previous invasive prostate intervention (TURP, laser, ablation, etc.)
History of prostate or bladder cancer
Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
Evidence of neurogenic bladder
Indwelling Foley catheter or clean intermittent catheterization (CIC) in the prior 30 days
Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy
Other conditions / status listed in full protocol

Where it is running

Urology Specialist Group — Hialeah, Florida, United States

Full record on ClinicalTrials.gov

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