NCT07534631Completed
Holmium Laser En-Bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle- Invasive Bladder Cancer
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 10 Apr 2026
- Start date
- 5 Jan 2025
- Primary completion date
- 5 Oct 2025
- Lead sponsor
- Beni-Suef University
- Diseases
- Bladder cancer
- NCT number
- NCT07534631
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 5 Jan 2025 to the primary completion date, 5 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior bladder radiotherapy.
- Severe comorbidity precluding surgery.
Other illness
- Muscle-invasive disease suspected preoperatively or evidence of metastatic disease.
Other
- Pregnancy.
- Inability to provide informed consent.
- Upper urinary tract urothelial carcinoma or life expectancy less than 1 year
Who the study is looking for
- 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.
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beni-Suef University Hospital Coordinator of this site? Confirm its status | Banī Suwayf | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.