Clinical trial · Interventional
Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors
Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression. Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor. This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients. This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic fulguration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Active surveillance
- description
- After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery
- type
- ACTIVE_COMPARATOR
- label
- endoscopic fulguration
- description
- After a recurrence in patient with previous low grade bladder cancer tumor, fulguration under local anesthesia and sedation will be performed using a flexible cystoscope and a monopolar electrode
- interventionNames
- Procedure: Endoscopic fulguration
Primary outcomes (2)
- measure
- Progression rate
- timeFrame
- two years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent Ta-T1a (above muscularis mucosa) LOW GRADE bladder tumor * Accept cystoscopy surveillance * Main lession less than 10mm * Less than 7 lesions * Negative or low grade cytology * No solid aspect Exclusion Criteria: * previous High grade bladder cancer tumors * previous Cis * previous Upper Urinary Tract tumor * previous pelvic radiotherapy * hematuria * meatal localisation
References
Publications (0)
Data not yet available