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Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Study acronym: AlP-FrUiT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv10
  2. Primary completion date: Dec 2022 to Jun 2025
    • Study completion date: Dec 2022 to Jun 2026
    v9
  3. Primary completion date: Sep 2021 to Dec 2022
    • Study completion date: Oct 2021 to Dec 2022
    v8
  4. Start date changed from estimate of Dec 2020 to Oct 27, 2020
    • Interventions: intravesical instillation of sterile purified water (Device), intravesical instillation with HA-CS (Device) to intravesical instillation of sterile purified water (Drug), intravesical instillation with HA-CS (Drug)
    v7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2020 to Dec 2020
    • Site details revised at 2 of 2 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: May 2020 to Sep 2020
    • Primary completion date: Jun 2021 to Sep 2021
    v5
  2. Start date: Jan 2020 to May 2020v4
  3. Start date: Oct 2019 to Jan 2020v3
  4. Secondary endpoints revised (8)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04095572
Lead Sponsor University Hospital, Basel, Switzerland
Collaborators: IBSA Institut Biochimique SA
Conditions
(from sponsor)		 Urinary Tract Infections, Urinary Tract Infection (UTI)
Related terms Urinary Tract Infections
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov