Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

Prostatic Hyperplasia, Benign Clinical Trial

Official title:

Transperineal Laser Ablation for Treatment of LUTS Due to Benign Prostatic Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653117
• Other study ID #: 2018_149
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: May 23, 2022

Study information

• Verified date: June 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male
• = 40 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

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia
• Prostatic Hyperplasia, Benign

Intervention

Device:
• Transperineal laser ablation
Minimal invasive coagulation of prostatic tissue by laser

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Elesta S.R.L.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of technical successful TPLA treatments	Number of technical successful performed TPLA treatments without failures related to the machine or procedure.	24 hours following TPLA treatment
Primary	Incidence of TPLA treatment-emergent adverse events	Number of adverse events using the CTCAE v5.0. Procedural safety is shown when there are no adverse events of grade 3 or higher.	30 days following TPLA treatment
Secondary	Functional outcomes of TPLA	Functional outcomes of TPLA measured by uroflowmetry, expressed in change of Qmax.	12 months following TPLA treatment
Secondary	Spontaneous voiding post TPLA	The presence of spontaneous voiding following TPLA treatment	24 hours following TPLA treatment
Secondary	Erectile function	To evaluate erectile function after TPLA treatment, measured by the International Index of Erectile function 15 (IIEF-15) IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; Erectile function: Q1-5 Score range 0-5 + Q15 score range 1-5, total score 1-30, higher indicates better outcome; Orgasmic function: Q9-10 Score range 0-5, total score 0-10, higher indicates better outcome; Sexual desire: Q11-12 Score range 1-5, total score 2-10, higher indicates better outcome; Intercourse satisfaction: Q6-8 Score range 0-5, total score 0-15, higher indicates better outcome; Overall satisfaction: Q13-14 Score range 1-5, total score 2-10, higher indicates better outcome; All subscale are summed to combine them to a total IIEF-15 score.	12 months following TPLA treatment
Secondary	Antegrade ejaculation	To evaluate antegrade ejaculation after TPLA treatment, measured by patient reporting.	12 months following TPLA treatment