Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA (NCT04760483) | Clinical Trial Compass
UnknownPhase 1
Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA
United States20 participantsStarted 2020-11-20
Plain-language summary
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
Who can participate
Age range
40 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.