RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTAT... | NCT07289243

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2024Actual

Primary Completion Date

Dec 25, 2025Estimated

Completion Date

Dec 25, 2026Estimated

First Submitted Date

Dec 4, 2025

First Submission Date that Met QC Criteria

Dec 4, 2025

First Posted Date

Dec 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pasquale Ditonno, MD, Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariPrincipal Investigator

Lead Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TPLA (TRANSPERINEAL LASER ABLATION) 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TPLA	Other	Patients underwent TPLA tretment	Procedure: ECHOLASER-TPLA
TURP	Other	Patients underwent TURP tretment	Procedure: TURP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECHOLASER-TPLA	Procedure	transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.	TPLA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE		one, three, six, twelve mounth after treatment

Secondary Outcomes

Measure	Description	Time Frame
COMPARE Q-MAX UROFLOW		one, three, six, twelve mounth after treatment
COMPARE INPATIENT-TIMING		one, three, six, twelve mounth after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age, Lower urinary tract simptoms (IPSS >= 8), uncompliance or no achived drugs treatment for IPB, prostate volume 40ml-80ml , ability to express informed consent.

Exclusion Criteria:

previous surgical tretment for IPB, bladder catheter, bladder stones, urinary or seminal infections, hypo-/a-contractilitis of bladder, bladder tuomrs, urethral stricture, neurological bladder, refuse to sign informed consent

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcello MZ Zingarelli, medicine and surgery	Contact	+393405135446		marcellozingarelli86@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UOC Urologia e Trapianti di Rene Policlinico di Bari	Recruiting	Bari	ITALY/Bari	70124	Italy

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D011468	Prostatectomy
D013521	Urologic Surgical Procedures, Male
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative