Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: Endoscopic fulguration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Active surveillance<br>After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery | |
| Active Comparator: endoscopic fulguration<br>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 | Procedure: Endoscopic fulguration<br>* already included. WE will use Storz monopolar device for fulguration<br>* Other names: Active surveillance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression rate | Number of patients that progress during the follow up | two years | 
| Complications rate | Number and grade of complications in both arms. Clavien Dindo Scale will be used | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | number of recurrences | two years | 
| quality of life measured with CAVICAVENMI questionnaire | quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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active surveillance, fulguration, bladder cancer