Bladder Tumor (TURBT)NCT07534631
Holmium Laser En-Bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle- Invasive Bladder Cancer
A study testing Holmium Laser En-Bloc Resection of Bladder Tumor and Conventional Transurethral Resection of Bladder Tumor in people with Bladder Tumor (TURBT), run by Beni-Suef University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Bladder Tumor (TURBT)
- What is being tested?
- Holmium Laser En-Bloc Resection of Bladder Tumor and Conventional Transurethral Resection of Bladder Tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2025to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-Suef University Hospital
Banī Suwayf, Beni Suef Governorate, 62511
About this study
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)
- Being tested
- Holmium Laser En-Bloc Resection of Bladder Tumor, Conventional Transurethral Resection of Bladder Tumor
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium Laser En-Bloc Resection of Bladder TumorProcedure or surgery
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 TumorProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Transurethral Resection of Bladder Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after surgery (postoperative histopathological assessment)
Secondary outcomes (2)
Intraoperative Complications
Incidence of intraoperative complications including obturator nerve reflex, intraoperative bleeding, and bladder perforation.
Measured: During surgery
Tumor Recurrence at 3 Months
Incidence of bladder tumor recurrence at 3 months follow-up.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start5 Jan 2025
- Primary completion5 Oct 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Tumor (TURBT)Studies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdallah, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534631
- Sponsor's protocol ID
- FMBSUREC/05012025/Mahmoud
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser En-Bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle- Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07534631
- Acronym / sponsor ID
- FMBSUREC/05012025/Mahmoud
- Conditions
- Bladder Tumor (TURBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holmium Laser En-Bloc Resection (HoLERBT) | Experimental | Procedure: Holmium Laser En-Bloc Resection of Bladder TumorPatients 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. |
| Conventional TURBT | Active comparator | Procedure: Conventional Transurethral Resection of Bladder TumorPatients in this group will undergo conventional transurethral resection of bladder tumor (cTURBT), performed using standard resection techniques with a monopolar or bipolar resectoscope. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Muscle-invasive disease suspected preoperatively or evidence of metastatic disease.
- Prior bladder radiotherapy.
- Severe comorbidity precluding surgery.
- Pregnancy.
- Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium Laser En-Bloc Resection of Bladder TumorHolmium 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. | Procedure or surgery | Holmium Laser En-Bloc Resection (HoLERBT) |
| Conventional Transurethral Resection of Bladder TumorConventional 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. | Procedure or surgery | Conventional TURBT |
Primary outcome
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.
2 secondary outcomes
Intraoperative Complications
Time frame: During surgery
Tumor Recurrence at 3 Months
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium Laser En-Bloc Resection of Bladder Tumor and Conventional Transurethral Resection of Bladder Tumor in people with Bladder Tumor (TURBT), run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Detrusor Muscle in Resected Specimen (time frame: Immediately after surgery (postoperative histopathological assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.