Prospective comparative study between Deflux® and Vantris® for endoscopic treatment of vesico-ureteral reflux in children.

Prospective comparative study between Deflux® and Vantris® for endoscopic treatment of vesico-ureteral reflux in children. - DeVan studie

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41581

Enrollment

330

Registered

2012-11-02

Start date

2013-02-14

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

reflux VUR

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: • VUR grade II to V, established through MCUG

Exclusion criteria

Exclusion criteria: • Recurrent residual after micturition of more than 10% of the functional bladder capacity • Neurogenic or non-neurogenic bladder disorder or a history of intermittent catheterization • Earlier surgery to the bladder or the ureter • urinary-tract infection, not treated • Obstipation, not treated • Children of parents who, for principal or other reasons, refuse to administer antibiotic prophylaxis when the paediatric urologist or treating physician indicates this to be necessary. • Non-compliance, proven during the progress of the case history so far • Abnormal level of serum creatinin

Design outcomes

Primary

Measure	Time frame
The proportion of successful treatments per treatment arm is equal (successful = VUR	—

Secondary

Measure	Time frame
• The treatment with Vantris® is cost-effective compared to treatment with Deflux® • There is no significant difference in the number of urinary-tract infections within 6 months after the treatment in both treatment arms. In case there is, it is in favour of fewer infections in the Vantris® treatment arm. • There is no significant difference between both treatment arms in the number of recurrences of VUR in the long term (2.5, 5 and 10 years). In case there is a difference, it is in favour of fewer recurrences in the Vantris® treatment-arm.	—

Measure

Time frame

• The treatment with Vantris® is cost-effective compared to treatment with Deflux® • There is no significant difference in the number of urinary-tract infections within 6 months after the treatment in both treatment arms. In case there is, it is in favour of fewer infections in the Vantris® treatment arm. • There is no significant difference between both treatment arms in the number of recurrences of VUR in the long term (2.5, 5 and 10 years). In case there is a difference, it is in favour of fewer recurrences in the Vantris® treatment-arm.

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Countries

Netherlands

Outcome results