Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

  • STATUS
    Recruiting
  • days left to enroll
    7
  • participants needed
    20
  • sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Updated on 1 February 2021

Summary

Rationale: With age a large group of men experience lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). Standard treatment is a transurethral resection of the prostate or laser vaporization. As these techniques enter the prostate via the urethra, are invasive and require general or spinal anaesthesia. Transperineal laser ablation (TPLA) is a minimal invasive procedure, that can be performed under local anaesthesia.

Objective: The primary objective of this study is to prove feasibility and safety of TPLA for LUTS due to BPO in healthy men.

Secondary objectives: The secondary objectives are to determine functional voiding, erectile outcomes and changes on imaging.

Description

This study is set up as a prospective, single centre, interventional pilot study.

Eligible patients are diagnosed with LUTS due to BPO at the outpatient clinic of the department of Urology at the Academic Medical Center (AMC) and have an indication for surgical treatment. The investigators aim to include 20 patients.

Eligible patients will be informed about this study by the urologist in the outpatient clinic. Information about the study will be provided both orally and in written form.

The TPLA procedure is performed with the Echolaser X4 system. The system uses a diode laser source that operates at the 1064nm wavelength. The maximum energy delivered is 10 watts per laser source. The system works with the concept of thermoablation, resulting in coagulative necrosis of tissue. Two to four fibers are introduced in the prostate under untrasound vision. Ablation will be performed with 3 watts power per fibre and a total of 1200 - 1800 J will be delivered per fibre in 400 - 600 s.

Follow-up will exist of four visits following surgery at 4 weeks, three, six and 12 months. The visits imply medical history, adverse event registration, physical examination (on indication) and uroflowmetry. Patient-reported outcome measures (PROMs) are used to measure functional outcomes. Used PROMs are the International Prostate Symptom Score (IPSS), International Index of Erectile Function 15 (IIEF-15), Visual Analogue Scale (VAS) and hematuria grading scale (HGS). In addition to this, imaging will exist of a contrast enhanced ultrasound (CEUS) at four weeks and 12 months.

Details
Condition Benign prostatic hypertrophy, Benign Prostatic Hyperplasia (Enlarged Prostate), Benign Prostatic Hyperplasia (Enlarged Prostate)
Treatment Transperineal laser ablation
Clinical Study IdentifierNCT03653117
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on1 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male
years of age
Peak urinary flow rate (Qmax): 5 mL/sec to 15 mL/sec, with a minimum voided volume of 125 mL, measured with uroflowmetry or urodynamic investigation
Post-void residual (PVR): 250 mL
Prostate volume: 30 and 120 cc, measured by transrectal ultrasound
Urodynamic investigation proven bladder outlet obstruction
Signed informed consent

Exclusion Criteria

Previous invasive prostate intervention (TURP, laser, ablation, etc.)
History of prostate or bladder cancer
Indwelling Foley catheter or clean intermittent catheterization (CIC)
PSA of 3.0 ng/mL without negative biopsies
Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy
Other conditions / status
Active urinary tract infection / prostatitis
Macroscopic haematuria without a known contributing factor
Poor detrusor muscle function or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries, (diabetic) polyneuropathy)
Concurrent malignancy except basal skin cancer
History of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis)
History of pelvic radiation therapy or radical pelvic surgery
History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date
Bladder stones
Medical contraindication for undergoing TPLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery)
Diagnosed or suspected bleeding disorder
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note