The aim of this study is to evaluate the: 1) prevalence of structural (urethral strictures) and 2) functional urethral complications (LUTS, abnormal uroflow characteristics and increased post void residual (PVR) volume) in boys post IUC placement.
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
In adult patients the repoted incidence of urethral strictures or erosion post
placement of an indwelling urinary catheters (IUC) is 3.4%. In females urethral
strictures are reported to be rare. In children the long-term complications of
IUC have been studied scarcely, whereas we hypothesise they may experience an
increased risk. Additionally, lower urinary tract symptoms (LUTS) in children
may remain unrecognized or not directly associated with a previous IUC
placement.
Study objective
The aim of this study is to evaluate the:
1) prevalence of structural (urethral strictures) and
2) functional urethral complications (LUTS, abnormal uroflow characteristics
and increased post void residual (PVR) volume) in boys post IUC placement.
Study design
Historic cohort pilot study
Study burden and risks
The proposed study was evaluated as carrying negligible risk with minimal
burden for the patient.
This is a group-related study, since the long-term sequela of IUC in children
have not yet been systematically investigated.
Measurements:
1) Patients and parents/legal guardians will complete the (p)VSSES
questionnaire, which comprises 14 questions on micturition.
2) One visit of 1-4 hours at the out patient department (or during planned
visit):
2.1) An uroflow assessment, which is a non-invasive investigation of <5
minutes similar as voiding on a normal toilet.
2.2) An abdominal Bladderscan ultrasound (non-invasive) of <5 minutes.
3) Patients will complete a two day bladder diary
4) Patients with abnormal results based on the aforementioned investigations,
will be invited for and benefit from an additional urological investigation at
the discretion of a pediatric urologist, which will take place as part of
regular patient care. However, no invasive procedures will be executed for
study purpose only.
Meibergdreef 9
Amsterdam 1105ZA
NL
Meibergdreef 9
Amsterdam 1105ZA
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74398.018.20 |