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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05148728

Enrollment

120

Registered

2021-12-08

Start date

2021-12-15

Completion date

2024-03-15

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

active surveillance, fulguration, bladder cancer

Brief summary

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.

Interventions

PROCEDUREEndoscopic fulguration

already included. WE will use Storz monopolar device for fulguration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026