RANDOMIZEDNCT07289243
Treatment for Benign Prostatic Obstruction: Transperineal Laser Ablation
A study testing ECHOLASER-TPLA and TURP in people with RANDOMIZED, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 2 sites in Italy.
Trial summary
THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TRANSPERINEAL LASER ABLATION (TPLA) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- RANDOMIZED
- What is being tested?
- ECHOLASER-TPLA and TURP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 14 Jul 2024to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower urinary tract symptoms (IPSS >= 8);
- Poor efficacy after at least six months of medical therapy or intolerance to medical treatment for BPH;
- Prostate volume: 40ml-80ml;
- Ability to give informed consent.
Who cannot join
- Previous surgery for benign prostatic hyperplasia;
- Indwelling bladder catheter or intermittent bladder catheterization;
- Diagnosis of bladder stones;
- Recurrent urinary tract infections or intraprostatic abscesses;
- Severe detrusor hypocontractility or acontractility;
- Hydronefrosis due to urinary retention;
Show all 9Show fewer
- Urethral strictures or diagnosis of neurogenic bladder;
- Diagnosis of bladder cancer;
- Diagnosis or clinical suspicion of prostate cancer.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 1 recruiting
- Recruiting
UOC Urologia e Trapianti di Rene Policlinico di Bari
Bari, ITALY/Bari, 70124
Pasquale PD Ditonno, medicine and surgery, +390805594390, pasquale.ditonno@uniba.it
- Active, not recruiting
UOC Urologia e Trapianti di Rene Policlinico di Bari
Bari, ITALY/Bari, 70124
About this study
Official title: Randomized Clinical Trial Comparing Transurethral Prostate Resection (TURP) and Echolaser Soractelite-Transperineal Laser Ablation (TPLA ) in Patients With Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction
THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TRANSPERINEAL LASER ABLATION (TPLA) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.
- Conditions
- RANDOMIZED
- Being tested
- ECHOLASER-TPLA, TURP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHOLASER-TPLAProcedure or surgery
Also called TPLA
transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.
TURPProcedure or surgery
Transurethral resection of prostate, by uretrocistoscopy approach.
| Study group | Role | What they receive |
|---|---|---|
| TPLA | Other | Patients underwent TPLA tretment Receives: Procedure: ECHOLASER-TPLA |
| TURP | Other | Patients underwent TURP tretment Receives: Procedure: TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE)
After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms
Measured: one, three, six, twelve months after treatment
Secondary outcomes (11)
Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)
Uroflowmetry will be conducted to assess improvements in urinary maximum flow (Qmax: ml/sec). Differences among preoperative status versus 6, 12 months after treatment
Measured: Differences among preoperative status versus 6, 12 months after treatment
Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (MSHQ-EJD)
To assess the impact of the procedures on anterograde ejaculatory function, we will use the Male Sexual Health Questionnaire - Ejaculation Disfunction (MSHQ-EJD). Higher scores reflect better ejaculatory function, with the questionnaire ranging from 0 to 15. Additionally, a final question, scored from 0 to 5, assesses the difficulty experienced by the patient during ejaculation. For this specific question, higher scores correspond to greater levels of difficulty reported (0: no difficulty, 5: extremely bothered).
Measured: Differences among preoperative status versus 3, 6, 12 months after treatmente, three, six, twelve mounth after treatment
Changes in Post Void Residual (PVR)
Uroflowmetry will be conducted to assess improvements post voided residual (PVR: ml). Milliliters will be used to report PVR
Measured: Differences among preoperative status versus 3, 6, 12 months after treatment
Changes in Sexual Funtion
To assess the impact of the procedures on penile erection, we will use the International Index of Erectile Function (IIEF5) questionnaire.
The questionnaire hasn't got units of measurement; they are expressed in absolute numbers. Higher IIEF5 values indicate better erectile function.
The IIEF-5 score ranges from 0 to 25. Scores of 22 to 25 indicate normal erectile function, while scores of 17 to 21 suggest mild erectile dysfunction. Scores between 12 and 16 indicate mild-to-moderate dysfunction, 8 to 11 moderate dysfunction, and scores below 7 indicate severe erectile dysfunction
Measured: Differences among preoperative status versus 3, 6, 12 months after treatment
Change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) score
Total NIH-CPSI score ranging from 0 to 43, assessing pain, urinary symptoms, and quality of life. Higher scores indicate worse symptoms.
Measured: Differences among preoperative status versus 3, 6, 12 months after treatment
Change in Pelvic Pain and Urgency/Frequency (PUF) score
Pelvic Pain and Urgency/Frequency (PUF) questionnaire score (0-35), higher scores indicate worse symptoms.
Measured: Differences among preoperative status versus 3, 6, 12 months after treatment
Prostate Specific Antigen (PSA) value
PSA will be reported by combining nanograms and milliliters (ng/ml).
Measured: Differences among preoperative status versus 3, 6, 12 months after treatment
Postoperative complications
The Clavien-Dindo classification categorizes complications related to a surgical procedure on a scale from 1 to 5. The severity of the complication increases with higher Clavien-Dindo scores.
Measured: up to 3 months
Length of hospital stay
Duration of hospitalization measured in days from admission to discharge.
Measured: From hospital admission to discharge at three days (up to three days)
Duration of urinary catheterization
Time (in days) from placement of the urinary catheter to its removal.
Measured: From catheter insertion to catheter removal at seven days (up to seven days)
Operative time
Duration of the procedure measured in minutes
Measured: During the surgical procedure (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start14 Jul 2024
- Primary completion25 Dec 2025
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RANDOMIZEDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289243
- Sponsor's protocol ID
- TPLA-2023
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Transurethral Prostate Resection (TURP) and Echolaser Soractelite-Transperineal Laser Ablation (TPLA ) in Patients With Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction
- ClinicalTrials.gov ID
- NCT07289243
- Acronym / sponsor ID
- TPLA-2023
- Conditions
- RANDOMIZED
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TRANSPERINEAL LASER ABLATION (TPLA) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPLA | Other | Procedure: ECHOLASER-TPLAPatients underwent TPLA tretment |
| TURP | Other | Procedure: TURPPatients underwent TURP tretment |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lower urinary tract symptoms (IPSS >= 8);
- Poor efficacy after at least six months of medical therapy or intolerance to medical treatment for BPH;
- Prostate volume: 40ml-80ml;
- Ability to give informed consent.
Key exclusion criteria (9 listed)
- Previous surgery for benign prostatic hyperplasia;
- Indwelling bladder catheter or intermittent bladder catheterization;
- Diagnosis of bladder stones;
- Recurrent urinary tract infections or intraprostatic abscesses;
- Severe detrusor hypocontractility or acontractility;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHOLASER-TPLAAlso: TPLAtransperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide. | Procedure or surgery | TPLA |
| TURPTransurethral resection of prostate, by uretrocistoscopy approach. | Procedure or surgery | TURP |
Primary outcome
Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE)
Time frame: one, three, six, twelve months after treatment
After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms
11 secondary outcomes
Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)
Time frame: Differences among preoperative status versus 6, 12 months after treatment
Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (MSHQ-EJD)
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatmente, three, six, twelve mounth after treatment
Changes in Post Void Residual (PVR)
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Changes in Sexual Funtion
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) score
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Change in Pelvic Pain and Urgency/Frequency (PUF) score
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Prostate Specific Antigen (PSA) value
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Postoperative complications
Time frame: up to 3 months
Length of hospital stay
Time frame: From hospital admission to discharge at three days (up to three days)
Duration of urinary catheterization
Time frame: From catheter insertion to catheter removal at seven days (up to seven days)
Operative time
Time frame: During the surgical procedure (day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECHOLASER-TPLA and TURP in people with RANDOMIZED, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcello MZ Zingarelli, medicine and surgery (+393405135446, marcellozingarelli86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE) (time frame: one, three, six, twelve months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.