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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Tumor (TURBT)
• Intervention / Treatment: Procedure: Holmium Laser En-Bloc Resection of Bladder Tumor; Procedure: Conventional Transurethral Resection of Bladder Tumor

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Beni Suef Governorate
    • Banī Suwayf, Beni Suef Governorate, Egypt, 62511
      • Beni-suef university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 30 years or older.
• Patients with cystoscopically suspected primary NMIBC planned for endoscopic resection.
• Fit for surgery and anesthesia.
• Able and willing to provide written informed consent and comply with follow-up.

Exclusion Criteria:

• Muscle-invasive disease suspected preoperatively or evidence of metastatic disease.
• Prior bladder radiotherapy.
• Severe comorbidity precluding surgery.
• Pregnancy.
• Inability to provide informed consent.
• Upper urinary tract urothelial carcinoma or life expectancy less than 1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Holmium Laser En-Bloc Resection (HoLERBT); Patients in this group will undergo holmium laser en-bloc resection of bladder tumor (HoLERBT). The procedure involves complete tumor excision in a single piece using a holmium laser, allowing improved specimen quality and better hemostasis.	Procedure: Holmium Laser En-Bloc Resection of Bladder Tumor; Holmium laser en-bloc resection of bladder tumor (HoLERBT) is a surgical technique in which the bladder tumor is removed in a single piece using a holmium laser. The procedure allows precise dissection, improved hemostasis, and better preservation of specimen integrity for pathological assessment.
Active Comparator: Conventional TURBT; Patients in this group will undergo conventional transurethral resection of bladder tumor (cTURBT), performed using standard resection techniques with a monopolar or bipolar resectoscope.	Procedure: Conventional Transurethral Resection of Bladder Tumor; Conventional transurethral resection of bladder tumor (cTURBT) is a standard surgical procedure in which the tumor is removed in multiple fragments using a monopolar or bipolar resectoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Detrusor Muscle in Resected Specimen	Assessment of the quality of tumor resection based on the presence of detrusor muscle in the histopathological specimen obtained after surgery.	Immediately after surgery (postoperative histopathological assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Complications	Incidence of intraoperative complications including obturator nerve reflex, intraoperative bleeding, and bladder perforation.	During surgery
Tumor Recurrence at 3 Months	Incidence of bladder tumor recurrence at 3 months follow-up.	3 months after surgery

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2025
• Primary Completion (Actual): October 5, 2025
• Study Completion (Actual): January 5, 2026

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: FMBSUREC/05012025/Mahmoud

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No