Alternative Prophylaxis in Female Recurrent Urinary Tract Infections
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented history of rUTI, defined as ≥ 3 episodes of (un)complicated UTI documented by urine culture with the isolation of ≥103 cfu/ml of an identified pathogen in the last year with clinical symptoms OR 2 episodes in the last 6 month
Disqualifiers
No informed consent
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)
Trial design
Design model
Parallel
Treatments tested in this trial
intravesical instillation with HA-CS
Drugintravesical instillation with HA-CS (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Lodi, Italy)
intravesical instillation of sterile purified water
Drugintravesical 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)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: intervention group AActive comparator 1 intervention
Group B: control group BPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials
Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials (cumulative number)
Time frame
within 12 months after randomisationSecondary outcomes
1
Symptomatic UTI (based on clinical diagnosis supported by measured bacteriuria of ≥103 cfu/ml) treated with antimicrobials
Symptomatic UTI (based on clinical diagnosis supported by measured bacteriuria of ≥103 cfu/ml) treated with antimicrobials (cumulative number)
Time frame
at screening and at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8, week 12) and at follow-up visits after randomization (month 6, month 9, month 12)2
Symptoms of UTI according to the Acute Cystitis Symptom Score (ACSS) (cumulative number of each symptom)
Change in Acute Cystitis Symptom Score (ACSS). The first part of the ACSS questionnaire consists of 14 questions. The first 6 questions assess typical symptoms of UTI: frequency, urgency, pain and burning during urination, sensation of incomplete bladder emptying, pain/discomfort in the lower abdomen, visible hematuria. Each question concerning urinary symptoms allows the patient to choose one out of four answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 3. The score can range between 0 and 18. It has been validated and a score ≥ 6 seems to be very indicative for the diagnosis of an UTI.
Time frame
at screening and at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8, week 12) and at follow-up visits after randomization (month 6, month 9, month 12)3
Time to UTI recurrence (as days between randomisation and the first recurring UTI)
Time to UTI recurrence (as days between randomisation and the first recurring UTI)
Time frame
at screening and at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8, week 12) and at follow-up visits after randomization (month 6, month 9, month 12)4
Asymptomatic bacteriuria of ≥105 cfu/ml
Asymptomatic bacteriuria, measured by number of colony forming Units (cfu) of ≥105 cfu/ml
Time frame
at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8) if the urine dipstick is suspicious, at the 7th instillation (= week 12 )and at 12 month follow-upSponsors and contacts
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University Hospital, Basel, Switzerland
Lead sponsor
IBSA Institut Biochimique SA
Collaborator
Source ClinicalTrials.gov