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

NCT07534631 | Completed

• 1 other identifier: FMBSUREC/05012025/Mahmoud
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intraoperative Complications

  During surgery

• Tumor Recurrence at 3 Months

  3 months after surgery

Study Arms (2)

Holmium Laser En-Bloc Resection (HoLERBT)

EXPERIMENTAL

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

Conventional TURBT

ACTIVE COMPARATOR

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

Interventions

Holmium Laser En-Bloc Resection of Bladder Tumor PROCEDURE

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.

Holmium Laser En-Bloc Resection (HoLERBT)

Conventional Transurethral Resection of Bladder Tumor PROCEDURE

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.

Conventional TURBT

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suef Governorate, 62511, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: January 5, 2025
• Primary Completion: October 5, 2025
• Study Completion: January 5, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

EG (1)