Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study

Recurrent Urinary Tract Infection Clinical Trial

— GT RACING  

Official title:

Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652374
• Other study ID #: 111802
• Secondary ID: NL76892.091.21
• Status: Recruiting
• Phase: Phase 4
• Start date: October 20, 2022
• Est. completion date: October 2025

Study information

• Verified date: November 2022
• Source: Radboud University Medical Center
• Contact: Dick Janssen, MD, PhD
• Phone: +31 6 41856516
• Email: dick.janssen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The GT RACING is a study comparing the efficacy of HA-CS bladder installations with prophylactic antibiotics in the prevention of recurrent urinary tract infections (rUTI).

Description:

The main objective of the study is to compare efficacy between hyaluronic acid - chondroitin sulphate (HA-CS) treatment and gold standard treatment (AB prophylaxis). Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.

Study population: Female (>18rs) with at least 3 symptomatic urinary tract infections (UTI's) in the previous year with no adequate curable therapeutic options.

Intervention: Intervention group (n=50): 50ml of sterile Ialuril (HA 1.6% CS 2%) weekly for 6 weeks, followed by monthly maintenance therapy for 1 year. Control group (n=50): oral nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 1 year. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.

During the study patients will fill-out questionnaires regarding symptoms, quality of life and use of healthcare. Furthermore urine will be collected at set timepoints.

Main study parameters/endpoints: The main study parameter is the number of UTI per patient-year. Secondary parameters are time to rUTI (wks.), outcome on the global responce assessment (GRA) scale, pattern of antibiotic resistance, outcome on the patient reported outcome questionnaire, cost effectiveness and Quality-of-life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult female patients (>18 years) who had at least 3 symptomatic UTI's in the previous year with no adequate curable therapeutic options (e.g. bladder stones)

2. At least one UTI's must be confirmed with a positive culture and antibiogram, further UTI's must be confirmed with a urine sediment with positive nitrite or a positive culture.

Exclusion Criteria:

1. Male

2. < 18 years

3. Pregnant

4. Already on GAG therapy

5. Already on prophylactic antibiotics

6. Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months

7. Had Gentamicin or other antibiotic instillations in the previous 2 months

8. Allergic to >3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin)

9. A urinary fistula

10. Urinary stones

11. Urogenital cancer

12. Bladder Pain Syndrome - Interstitial Cystitis

13. Chronic pelvic pain

14. Had a STD untreated or treated in the previous 2 months

15. A urinary diversion

16. An Indwelling catheter

17. A suprapubic catheter

18. Performing >1/day self-catheterization

19. A residue after voiding (PVR) of >200ml

20. Unable (also legal) to give informed consent

21. Recurrent urosepsis

22. Multiresistant bacteria in previous urine cultures

23. Contra-indications and interactions for Nitrofurantoin: severe kidney disfunction (GFR < 30), lung- or liver problems or neuropathy after previous use of nitrofurantoin, acute porphyria, known G6PD deficiency, use of magnesium trisilicate.

24. Contra-indications and interactions for trimethoprim: severe kidney or liver dysfunction, blood count abnormality, use of vitamin K antagonists, use of folic acid antagonists, use of ace inhibitors

25. Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD)

26. Does not tolerate catheterization

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Recurrence
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

Device:
• Ialuril 50ml Prefill
Bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 1 year

Drug:
• Nitrofurantoin
100mg daily (1dd100mg or 2dd50mg) for 1 year. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University Medical Center	Goodlife Pharma B.V., IBSA Institut Biochimique SA

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of urinary tract infections	Number of urinary tract infections per patient-year	1 year
Secondary	Time to first urinary tract infection	Time to first urinary tract infection	1 year
Secondary	Global Assessment of Improvement	Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best)	7 weeks, 6 months and 12 months
Secondary	Antibiotics resistance	Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups	Baseline, 6 months, 12 months
Secondary	Cost-effectiveness: medical consumption questionnaire	Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire'	Baseline, 6 months, 12 months
Secondary	Cost-effectiveness: productivity cost questionnaire	Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'productivity cost questionnaire'	Baseline, 6 months, 12 months
Secondary	Therapy specific patient reported outcomes (symptoms & bother)	Differences in therapy specific patient reported outcomes between both patient groups (measured in Therapy Specific Patient Reported Outcome (PRO) Questionnaire on Symptom & Bother rUTI & GAG therapy)	baseline, 7 weeks, 6 months, 9 months, 12 months
Secondary	General quality of life questionnaire (mobility, self-care, daily activities, pain/discomfort, anxiety/depression)	Is there a difference in the Quality-of-life between the 2 therapies during follow-up using ED-5D 5L questionnaire	baseline, 7 weeks, 6 months, 9 months, 12 months