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Reducing costs of surveillance of patients with non-muscle invasive bladder cancer.

Reducing costs of surveillance of patients with non-muscle invasive bladder cancer. - URICA II

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44747
Enrollment
435
Registered
2014-12-11
Start date
2015-02-09
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Non-muscle invasive bladder cancer superficial bladder cancer

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) (Previous) primary NMIBC 2) Currently under surveillance for possible recurrent disease 3) Monitored by the urology patient archives in the participating hospitals

Exclusion criteria

Exclusion criteria: 1) Patients upgraded at reTUR to MIBC 2) Patients presenting with MIBC 3) Patients below 21 years of age. ;After the initial TUR, a second TUR (reTUR) is recommended for patients with pT1 tumors. This is to establish whether resection was radical and when there is remaining tumor whether the tumor is muscle-invasive. In the latter case these patients will be excluded because they do not belong to the NMIBC category

Design outcomes

Secondary

MeasureTime frame
- 15% more recurrences detected in patients with a primary high-risk tumor. - Indication that these are of lower stage. - Cost-effectiveness.

Primary

MeasureTime frame
- 15% more recurrences detected in the maximal care arm in patients in the low/intermediate risk group. - Proof that in the optimal care arm (intended to be the future follow-up procedure) is safe regarding detected versus missed recurrences. - Calculation of % of cystoscopies that would be unnecessary in the future. - Cost-effectiveness of this strategy.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)