Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

NCT04095572 | Recruiting Phase 4

• 1 other identifier: 2019-01377; me19Bausch
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Urinary Tract Infections; Urinary Tract Infection (UTI)

Keywords

Hyaluronic acid (HA); Chondroitin sulphate (CS); antimicrobial resistance rates; Intravesical instillation; HA-CS instillations; Recurrent Urinary Tract Infection (rUTI)

Outcome Measures

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)

  within 12 months after randomisation

Secondary Outcomes (8)

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

  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)

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

  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)

  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)

• Asymptomatic bacteriuria of ≥105 cfu/ml

  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

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

  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)

Study Arms (2)

intervention group A

ACTIVE COMPARATOR

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

Drug: intravesical instillation with HA-CS

control group B

PLACEBO COMPARATOR

50 ml sterile purified water weekly for four weeks, then every second week in the second month and four weeks later

Drug: intravesical instillation of sterile purified water

Interventions

intravesical instillation with HA-CS DRUG

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

intervention group A

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)

control group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• IBSA Institut Biochimique SA: collaborator

Study Sites (2)

Department of Gynecology, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Department of Urology, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Administration, Intravesical

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Kathrin Bausch, Dr. med

  Department of Urology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Bausch, Dr. med

CONTACT

+41 61 265 72 80; kathrin.bausch@usb.ch

Hans-Helge Seifert, Prof. Dr. MD

CONTACT

+41 61 265 72 80; helge.seifert@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, parallel arm, superiority, multicentre, randomised trial with blinded treating physicians, patients and outcome assessors

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: October 27, 2020
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CH (2)