Gag Therapy for Recurrent urine tract infection Assessing Comparability to International Nitrofurantoin Gold standard study.

Gag Therapy for Recurrent urine tract infection Assessing Comparability to International Nitrofurantoin Gold standard study. - GT RACING

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54106

Enrollment

100

Registered

2022-08-09

Start date

2022-10-20

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary tract infections

Interventions

Intervention: Bladder instillations with 50ml of sterile Ialuril weekly for 6 weeks, followed by monthly maintenance therapy for 6 months. Every bladder instillation will take around 30 minutes. Th

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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) All UTI*s must be confirmed with a urine sediment with positive nitrite or positive urine cultures.

Exclusion criteria

Exclusion criteria: Male, 1/day, GFR

Design outcomes

Primary

Measure	Time frame
The main study parameter is the number of UTI per patient per treatment.	—

Secondary

Measure	Time frame
Secondary parameters are - Time to first recurrence of UTI - Changes in the outcome on the GRA scale during follow-up. - Differences in the pattern of antibiotic resistance between both treatments (measured with urine cultures and antibiograms) - Cost effectiveness of both therapies (measured with iMCQ and iPCQ) - Changes in quality of life during both treatments (measured with ED-5D-5L) - Changes in therapy specific patient reported outcomes during both treatments (measured with Therapy specific patient reported outcome questionnaire) - Side effects in both treatments, measured with Clavien-Dindo-system	—

Measure

Time frame

Secondary parameters are - Time to first recurrence of UTI - Changes in the outcome on the GRA scale during follow-up. - Differences in the pattern of antibiotic resistance between both treatments (measured with urine cultures and antibiograms) - Cost effectiveness of both therapies (measured with iMCQ and iPCQ) - Changes in quality of life during both treatments (measured with ED-5D-5L) - Changes in therapy specific patient reported outcomes during both treatments (measured with Therapy specific patient reported outcome questionnaire) - Side effects in both treatments, measured with Clavien-Dindo-system

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)