The effect of clinical characterization of children with bedwetting on the efficacy of therapy.

Phase 1

• Conditions: Enuresis nocturna; MedDRA version: 20.1Level: LLTClassification code 10014930Term: Enuresis (non-organic)System Organ Class: 100000004873; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2017-002169-23-DK
• Lead Sponsor: Søren Rittig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-30
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age 6-14 years.
2. Three or more wet nights per week regarding the home registrations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Ongoing constipation and/or faecal incontinence.
2. Daytime symptoms such as urgency, frequency or incontinence.
3. Recurrent urinary tract infections.
4. Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated.
5. Neurological and/or known clinically significant anatomical abnormalities of the urinary tract.
6. Former operations in the urinary tract.
7. Prior or ongoing treatment with alarm, desmopressin or anticholinergics.
8. Ongoing medication that may interfere with the parameters tested.
9. Pregnant or lactating girl.
10. Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatraemia or SIADH.
11. Hypersensitivity / allergy to substances in the tablets.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified