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PEG3350 + Urotherapy for LUTD
NCT02336906Phase 4
Key facts
- Status
- Withdrawn
- Start
- Jan 2020
- Primary completion
- Jul 2020
- Countries
- 1
- Sponsor
- Rabin Medical Center
- Modality
- Injectable Hydrogels, Implantable Hydrogels, Biodegradable Polymers
- Conditions
- Lower Urinary Tract Dysfunction (LUTD)
01
Overview
Phase 4, randomised, single-blind trial of polyethylene glycol 3350 in Lower Urinary Tract Dysfunction (LUTD) (2 arms), sponsored by Rabin Medical Center. Primary endpoint: Complete or Partial response based on Vancouver score at 14 weeks. Planned start Jan 2020; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Urotherapy + Constipation Treatment
PEG3350 + Behavioral Urotherapy
Urotherapy alone
Standard Behavioral Urotherapy
03
Who it enrols
Children aged 5-17 with lower urinary tract dysfunction (score >11 on Vancouver Questionnaire) who do not meet Rome III criteria for functional constipation.
04
Endpoints
Primary
Complete or Partial response based on Vancouver score
Secondary
Response in patient subgroups with fecal loading vs without
Sustained Response 12 weeks after intervention
Number of participants with adverse effects
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