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

Completed

Conditions: reflux
VUR
10038360

Registration Number: NL-OMON41581

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 330

Inclusion Criteria

• VUR grade II to V, established through MCUG < 1 year before surgery
• No or treated dysfunctional voiding pattern
• No or treated constipation
• No active urinary-tract infection on the day of surgery
• Child between 1 and 18 years of age
• Normal serum creatinin level

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of successful treatments per treatment arm is equal (successful<br /><br>= VUR <= grade 1 and/or no urinary-tract infections 6 months after the<br /><br>operation): Deflux® compared to Vantris®. In case it is not, it will be in<br /><br>favour of more success for the Vantris® treatment-arm.</p><br>

Secondary Outcome Measures

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