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NCT Number: NCT04095572

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infection (UTI) Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gynecology, University Hospital Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

intravesical instillation with HA-CS

Drug

intravesical instillation with HA-CS (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Lodi, Italy)

intravesical instillation of sterile purified water

Drug

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)

Primary outcomes

  1. Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials

    Time frame: within 12 months after randomisation

    Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials (cumulative number)

Secondary outcomes

  1. Symptomatic UTI (based on clinical diagnosis supported by measured bacteriuria of ≥103 cfu/ml) treated with antimicrobials

    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)

    Symptomatic UTI (based on clinical diagnosis supported by measured bacteriuria of ≥103 cfu/ml) treated with antimicrobials (cumulative number)

  2. Symptoms of UTI according to the Acute Cystitis Symptom Score (ACSS) (cumulative number of each symptom)

    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)

    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.

  3. 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)

    Time to UTI recurrence (as days between randomisation and the first recurring UTI)

  4. Asymptomatic bacteriuria 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-up

    Asymptomatic bacteriuria, measured by number of colony forming Units (cfu) of ≥105 cfu/ml

  5. Detection of multidrug-resistant bacteria in urine culture (3Multiresistant gram negatives (MRGN), 4MRGN)

    Time frame: at screening and at 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)

    Detection of multidrug-resistant bacteria in urine culture (3MRGN, 4MRGN) (yes/no)

  6. Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD)

    Time frame: from randomisation to 12 months

    Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD)

  7. Change in Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale

    Time frame: prior to randomisation and at 1 month, 3 months, 6 months, 9 months, 12 months

    The PUF questionnaire consists of 12 questions. The first two questions allow the patient to choose one out of five answers (points 0-3), the following questions one out of four (points 0-3) indicating increasing severity of the particular symptom. Seven of the questions concern symptoms (total count 23), four questions are part of the bother score (total count 12). Total score consists of symptom score and bother score (total count 35). The change of the score is calculated by subtracting the score at 1 month, 3 months, 6 months, 9 months, 12 months from the score at enrolment

  8. Change in QoL Short Form (SF)-36 score

    Time frame: prior to randomisation and at 12 months

    The QoL SF-36 consists of 36 items including eight independent scales and two main dimensions 35 of the items are compressed into eight multi-item scales: (1) physical functioning is a ten-question scale; (2) role-physical is a four-item scale; (3) bodily pain is a two-item scale; (4) general health is a five-item scale; (5) vitality is a four-item scale; (6) social functioning is a two-item scale; (7) role-emotional is a three-item scale; and (8) mental health is a five-item scale. Hence, in the SF-36 scoring system, the scales are assessed quantitatively, each on the basis of answers to two to ten multiple choice questions, and a score between 0 and 100 is then calculated on the basis of well-defined guidelines, with a higher score indicating a better state of health. The change of the score is calculated by subtracting the score at 12 month from the score at enrolment.

Study contacts

Contact information is provided by the study sponsor or research team.

Hans-Helge Seifert, Prof. Dr. MD

CONTACT

[email protected]

+41 61 265 72 80

Kathrin Bausch, Dr. med

CONTACT

[email protected]

+41 61 265 72 80

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • IBSA Institut Biochimique SA

Registry information

Official study title

Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study

Acronym: AlP-FrUiT

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2019
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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