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New treatment option for Recurrent Urinary Tract Infection
Official title Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
ClinicalTrials.gov ID: NCT05652374
What this study is testing
What is Nitrofurantoin?
Nitrofurantoin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for recurrent urinary tract infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- Male
- \< 18 years
- Pregnant
- Already on GAG therapy
- Already on prophylactic antibiotics
- Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months
See the full eligibility criteria
- 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)
- 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.
- Male
- \< 18 years
- Pregnant
- Already on GAG therapy
- Already on prophylactic antibiotics
- Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months
- Had Gentamicin or other antibiotic instillations in the previous 2 months
- Allergic to \>3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin)
- A urinary fistula
- Urinary stones
- Urogenital cancer
- Bladder Pain Syndrome - Interstitial Cystitis
- Chronic pelvic pain
- Had a STD untreated or treated in the previous 2 months
- A urinary diversion
- An Indwelling catheter
- A suprapubic catheter
- Performing \>1/day self-catheterization
- A residue after voiding (PVR) of \>200ml
- Unable (also legal) to give informed consent
- Recurrent urosepsis
- Multiresistant bacteria in previous urine cultures
- 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...
- 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
- Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD)
- Does not tolerate catheterization
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
- Arnhem, Netherlands
- Nijmegen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands; Arnhem, Netherlands; Nijmegen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.