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Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

Primary Purpose

Prostatic Hyperplasia, Benign

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Transperineal laser ablation

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia, Benign focused on measuring Transperineal laser ablation, LUTS, BPO, Laser ablation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Academic Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TPLA

Arm Description

TPLA procedure

Outcomes

Primary Outcome Measures

Incidence of technical successful TPLA treatments

Number of technical successful performed TPLA treatments without failures related to the machine or procedure.

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.

Secondary Outcome Measures

Functional outcomes of TPLA

Functional outcomes of TPLA measured by uroflowmetry, expressed in change of Qmax.

Spontaneous voiding post TPLA

The presence of spontaneous voiding following TPLA treatment

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.

Antegrade ejaculation

To evaluate antegrade ejaculation after TPLA treatment, measured by patient reporting.

Full Information

NCT ID

NCT03653117

First Posted

August 22, 2018

Last Updated

June 16, 2022

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Elesta S.R.L.

1. Study Identification

Unique Protocol Identification Number

NCT03653117

Brief Title

Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

October 18, 2018 (Actual)

Primary Completion Date

May 23, 2022 (Actual)

Study Completion Date

May 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Elesta S.R.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Hyperplasia, Benign

Keywords

Transperineal laser ablation, LUTS, BPO, Laser ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

This study is a prospective, single centre, interventional pilot study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TPLA

Arm Type

Experimental

Arm Description

TPLA procedure

Intervention Type

Device

Intervention Name(s)

Transperineal laser ablation

Other Intervention Name(s)

Echolaser X4

Intervention Description

Minimal invasive coagulation of prostatic tissue by laser

Primary Outcome Measure Information:

Title

Incidence of technical successful TPLA treatments

Description

Number of technical successful performed TPLA treatments without failures related to the machine or procedure.

Time Frame

24 hours following TPLA treatment

Title

Incidence of TPLA treatment-emergent adverse events

Description

Number of adverse events using the CTCAE v5.0. Procedural safety is shown when there are no adverse events of grade 3 or higher.

Time Frame

30 days following TPLA treatment

Secondary Outcome Measure Information:

Title

Functional outcomes of TPLA

Description

Functional outcomes of TPLA measured by uroflowmetry, expressed in change of Qmax.

Time Frame

12 months following TPLA treatment

Title

Spontaneous voiding post TPLA

Description

The presence of spontaneous voiding following TPLA treatment

Time Frame

24 hours following TPLA treatment

Title

Erectile function

Description

Time Frame

12 months following TPLA treatment

Title

Antegrade ejaculation

Description

To evaluate antegrade ejaculation after TPLA treatment, measured by patient reporting.

Time Frame

12 months following TPLA treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Academic Medical Center

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105AZ

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

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