Alternative Prophylaxis in Female Recurrent Urinary Tract Infections
NCT ID: NCT04095572
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2020-10-27
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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intervention group A
50 ml of a sterile sodium HA (800 mg)- CS (1g) solution (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi, Italy) weekly for four weeks, then every second week in the second month and four weeks later
intravesical instillation with HA-CS
intravesical instillation with HA-CS (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Lodi, Italy)
control group B
50 ml sterile purified water weekly for four weeks, then every second week in the second month and four weeks later
intravesical instillation of sterile purified water
intravesical instillation of sterile purified water (packed and labelled according to Good Manufacturing Practice at IBSA Farmaceutici Italia Srl in Lodi, Italy to provide adequate blinding)
Interventions
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intravesical instillation with HA-CS
intravesical instillation with HA-CS (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Lodi, Italy)
intravesical instillation of sterile purified water
intravesical instillation of sterile purified water (packed and labelled according to Good Manufacturing Practice at IBSA Farmaceutici Italia Srl in Lodi, Italy to provide adequate blinding)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Concomitant UTI (\< 7 days prior to randomisation)
* Ongoing antimicrobial prophylaxis (e.g. for rUTI or for any other reason like endocarditis, transplanted patients under immunosuppression)
* Ongoing prophylactic strategy (e.g. immunoactive prophylaxis)
* Documented underlying urogenital abnormality (e.g. significant post voiding residual volume (\>50 ml), urethral stricture, urethral diverticula, urinary stone, reflux, urinary neoplasia), urological device (e.g. catheter, ureteral stent) or symptomatic pelvic floor disorder (e.g. genital prolapse stage ≥ II)
* Concomitant disease (i.e. renal insufficiency, diabetes mellitus, corticosteroid use)
* Urogenital urological or gynecological surgery \< 6 weeks
* Known allergy to the study medication
* Use of spermicides or intrauterine device
* Pregnancy
18 Years
70 Years
FEMALE
No
Sponsors
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IBSA Institut Biochimique SA
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Kathrin Bausch, Dr. med
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, University Hospital Basel
Locations
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Department of Gynecology, University Hospital Basel
Basel, , Switzerland
Department of Urology, University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-01377; me19Bausch
Identifier Type: -
Identifier Source: org_study_id
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