Clinical Trial

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Study acronym: AlP-FrUiT

Recruiting Phase 4

Record status

This record was last updated February 19, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Summary

Urological pathogens are effected by rising antimicrobial resistance rates due to the frequent use of antimicrobials for treatment and prophylaxis. Intravesical instillation with hyaluronic acid (HA) and chondroitin sulphate (CS) obtained positive outcomes in the treatment of overactive bladder, radiation cystitis and interstitial cystitis by replenishment of the glycosaminoglycan layer of the bladder. This study is to investigate whether intravesical instillation with HA-CS in patients with recurrent urinary tract infections (rUTI) is superior to a placebo instillation in terms of reduction of rate of symptomatic urinary tract infections (UTIs) (based on clinical diagnosis) needing treatment with antimicrobials within 12 months after randomisation.

Protocol Amendment History 9 amendments

This ClinicalTrials.gov record has been amended 9 times since 2019-09-17; most recent amendment 2025-02-18.

Status change: Not Yet Recruiting → Recruiting 2020-10-21

Trial Details

NCT Number	NCT04095572
Lead Sponsor	University Hospital, Basel, Switzerland Collaborators: IBSA Institut Biochimique SA
Conditions	Urinary Tract Infections, Urinary Tract Infection (UTI)
Enrollment	50 participants
Start Date	2020-10-27
Primary Completion	2025-06 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-02-19