Olfactory Fuctioning and Perceptie Sensations in Children with Incontinence

Recruiting

• Conditions: F98.0; F98.1; N39.4; Nonorganic enuresis; Nonorganic encopresis; Other specified urinary incontinence

• Registration Number: DRKS00014998
• Lead Sponsor: Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Age between 6,0 and 17,11 years

Within patient group: reliable Diagnosis of nocturnal enuresis (F98.0), daytime urinary incontinece (N39.4) or fecal incontinence (F98.1)

Within control group: diagnosis by exclusion of nocturnal enuresis (F98.0), daytime urinary incontinece (N39.4) or fecal incontinence (F98.1)

Exclusion Criteria

Children who suffer from diseases that comes along with a impacted sense of smell: e.g. acute inflammatory obstructive diseases (e.g. rhinitis, sinusitis or rhinosinusitis), internal diseases (e.g. diabetes mellitus, liver dysfunction, renal insufficiency), neurological diseases (e.g. epilepsy, craniocerebral trauma), cancer diseases, Sjögren syndrome, children whose cognitive functioning does not permit a reliable olfactory testing (IQ < 70), intake of specific medication such as calcium antagonists (e.g. Nifedipin, Felodipin, Amlodipin, Dilitiazem), antibiotics, chemotherapeutics (e.g. Methotrexat, Doxycyclin, Terbinafin, D-Penicillamin), beta-blocker, Dihydropyridine, ACE-inhibitors, other mediaction (e.g. Lovastatin, Amitriptylin, Enalapril, Amiodaron), chronic use of vasoconstrictive drugs (e.g. Xylometazolin )

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative olfactory performance: 1) absolute threshold 2) olfactory discrimination 3) olfactory identification 4) total olfactory performance score<br>Olfactory perceptive sensation: 1) valence 2) intensity<br><br>Olfactory performance will be assessed at three measure time points: t1 (Baseline), t2 (after 3 months), t3 (after 6 months).<br><br>The olfactory performance is assessed by the standardized olfactory test battery Sniffin’ Sticks. Subjects accomplish three subtest (threshold, discrimination and identification test). The following parameters are collected: a) absolute threshold score b) discrimination score c) identification score d) total olfactory performance score e) valence score f) intensity score.<br>

Secondary Outcome Measures

Name	Time	Method
The occurence of (comorbid) psychiatric disorders is assessed by the Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter (Kinder-DIPS).<br>Psychopathological and behavioral problems are assessed by the Child Behavior Checklist (CBCL 6-18).<br>Frequency of incontinence symptoms is assessed by the Fragebogen zum Einnässen/Einkoten.<br>If children’s intelligence is unknown it is assessed by using the Reynolds Intellectual Screening Test (RIST).<br><br>The occurence of (comorbid) psychiatric disorders, the frequency of incontinence symptoms and children's intelligence will be assessed at study begin (t1, Baseline).<br>Psychopathological and behavioral problems will be assessed at three measure time points: t1 (Baseline), t2 (after 3 months), t3 (after 6 months).<br>