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NCT Number: NCT07534631

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.

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Key information

Conditions

Bladder Tumor (TURBT) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University Hospital

Banī Suwayf, Beni Suef Governorate, 62511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Presence of Detrusor Muscle in Resected Specimen

    Time frame: Immediately after surgery (postoperative histopathological assessment)

    Assessment of the quality of tumor resection based on the presence of detrusor muscle in the histopathological specimen obtained after surgery.

Secondary outcomes

  1. Intraoperative Complications

    Time frame: During surgery

    Incidence of intraoperative complications including obturator nerve reflex, intraoperative bleeding, and bladder perforation.

  2. Tumor Recurrence at 3 Months

    Time frame: 3 months after surgery

    Incidence of bladder tumor recurrence at 3 months follow-up.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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