Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The GT RACING is a study comparing the efficacy of HA-CS bladder installations with prophylactic antibiotics in the prevention of recurrent urinary tract infections (rUTI).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult female patients (\>18 years) who had at least 3 symptomatic UTI's in the previous year with no adequate curable therapeutic options (e.g. bladder stones)
• At least one UTI's must be confirmed with a positive culture and antibiogram, further UTI's must be confirmed with a urine sediment with positive nitrite or a positive culture.
Locations
Other Locations
Netherlands
Rijnstate ziekenhuis
RECRUITING
Arnhem
Canisius wilhelmina ziekenhuis
RECRUITING
Nijmegen
Radboudumc
RECRUITING
Nijmegen
Contact Information
Primary
Dick Janssen, MD, PhD
dick.janssen@radboudumc.nl
+31 6 41856516
Backup
Cléo Baars, MD
cleo.baars@radboudumc.nl
+31 6 15400527
Time Frame
Start Date: 2022-10-20
Estimated Completion Date: 2027-10
Participants
Target number of participants: 100
Treatments
Other: Group A
Ialuril therapy for 6 months followed by nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months. In between therapies there is a 4 week wash-out period.
Other: Group B
Nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months followed by Ialuril therapy for 6 months. In between therapies there is a 4 week wash-out period.
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center
Collaborators: Goodlife Pharma B.V., IBSA Institut Biochimique SA