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

Phase 4

Recruiting

Conditions: Urinary tract infections
10046590

Registration Number: NL-OMON54106

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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

Male, < 18 yrs, pregnant, already on GAG therapy, Gentamycin bladder
instillations in the previous 2 months, allergic to Nitrofurantoin and
Trimethoprim, urologic conditions: fistula, stones, cancer, BPS-IC, catheter,
STD or a urinary diversion. Performing self-catheterisation > 1/day, GFR < 30,
Severe lung or kidney disfunction, not tolerate catherization

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the number of UTI per patient per treatment. </p><br>

Secondary Outcome Measures

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