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New treatment option for Urinary Tract Infections
Official title Alternative Prophylaxis in Female Recurrent Urinary Tract Infections
ClinicalTrials.gov ID: NCT04095572
What this study is testing
What is intravesical instillation with HA-CS?
intravesical instillation with HA-CS is an investigational medicine, being studied as a potential treatment for urinary tract infections.
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
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join 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...
You likely can't join 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...
- Concomitant disease (i.e. renal insufficiency, diabetes mellitus, corticosteroid use)
See the full eligibility criteria
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. 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.