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Holmium Laser Versus Conventional TURBT for Non-Muscle-Invasive Bladder Cancer: Randomized Controlled Trial, 100 Patients

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Summary

NIH ClinicalTrials.gov registered a prospective randomized controlled trial (NCT07534631) comparing holmium laser en-bloc resection (HoLERBT) with conventional transurethral resection (cTURBT) for treatment of non-muscle-invasive bladder cancer. A total of 100 patients will be randomized 1:1. The primary outcome is quality of pathological specimen assessed by presence of detrusor muscle. Secondary outcomes include perioperative complications, operative time, obturator nerve reflex, bladder perforation, positive surgical margins, persistent disease at second-look TURBT, and recurrence rates at 3 and 12 months.

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What changed

NIH registered a new prospective randomized controlled trial on ClinicalTrials.gov comparing two surgical techniques for non-muscle-invasive bladder cancer. The study will enroll 100 patients randomized to holmium laser en-bloc resection or conventional transurethral resection. Primary endpoint is pathological specimen quality; secondary endpoints include complications, operative time, and recurrence rates at 3 and 12 months.

Clinical investigators and healthcare institutions conducting bladder cancer research should be aware of this trial for potential participation or competitive intelligence. Patients with suspected non-muscle-invasive bladder cancer may seek enrollment. The study adds to evidence on minimally invasive surgical approaches for bladder tumor resection.

Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Holmium Laser En-Bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle- Invasive Bladder Cancer

N/A NCT07534631 Kind: NA Apr 16, 2026

Abstract

This study is a prospective randomized controlled trial comparing holmium laser en-bloc resection of bladder tumor (HoLERBT) with conventional transurethral resection of bladder tumor (cTURBT) in patients with suspected non-muscle-invasive bladder cancer (NMIBC).

A total of 100 patients will be randomly assigned in a 1:1 ratio to undergo either HoLERBT or cTURBT. The primary outcome is the quality of the pathological specimen, assessed by the presence of detrusor muscle. Secondary outcomes include perioperative complications, operative time, obturator nerve reflex, bladder perforation, positive surgical margins, persistent disease at second-look TURBT, and recurrence rates at 3 and 12 months, as well as recurrence-free survival.

This study aims to evaluate whether HoLERBT provides superior resection quality and improved clinical outcomes compared to conventional TURBT.

Conditions: Bladder Tumor (TURBT)

Interventions: Holmium Laser En-Bloc Resection of Bladder Tumor, Conventional Transurethral Resection of Bladder Tumor

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534631

Who this affects

Applies to
Clinical investigators Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trials Medical research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices

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