Skip to content

Long-term complications resulting from temporary indwelling urinary catheters in boys. A pilot study.

Long-term complications resulting from temporary indwelling urinary catheters in boys. A pilot study. - FOMUCAT study (FOllow Me Urinary CATheter)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55225
Enrollment
100
Registered
2021-01-21
Start date
2021-05-18
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

urethral strictures

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Sex: male, Age at placement of the indwelling urinary catheter (IUC): gestational age *37 weeks - *18 years, Age at follow up: *5 - *19 years, Cognitive development: no evidence of mental retardation, Duration of IUC: *24 hours, Date of IUC placement: *01-01-2016 Time of follow up: *3 months post IUC removal, Language: Child and at least 1 parent / caregiver have a sufficient mastery of the Dutch language (verbal and written)

Exclusion criteria

Exclusion criteria: Known existing anatomical abnormalities of the urinary tract, previous urological surgery (including circumcision and hypospadias), neurogenic disease and history of pelvis fracture, since these children already experience an increased risk of developing structural urethral complications. Declined informed consent.

Design outcomes

Primary

MeasureTime frame
In boys *18 years old * three months post IUC placement: 1. The prevalence of structural urethral complications: 1.1. Urethral strictures. 2. The prevalence of functional urethral and bladder complications: 2.1. LUTS. 2.2. Abnormal uroflow characteristics. 2.3. Increased post void residual (PVR) volume.

Secondary

MeasureTime frame
In boys *18 years old * three months post IUC placement: 1. The risk factors of developing urethral strictures and LUTS. 2. The characteristics of urethral strictures and LUTS.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)