Vaginal gel to prevent recurrent urinary tract infections

Prospective, Multicentric, Single Arm Clinical Investigation to Assess the Effectiveness and Safety of Multi-Gyn UT Protect Gel for Prevention of Recurrent Urinary Tract Infections

This trial will try a vaginal gel called Multi-Gyn UT Protect, applied twice weekly, to see if it prevents repeat UTIs in adult women who have had recent recurrent infections.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 84 Years
• Sex: Female
• Sponsor: Karo Pharma AB (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Villeurbanne)
• Trial ID: NCT07233473 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls 50 adult women with a history of uncomplicated recurrent UTIs to receive a vaginal gel (Multi-Gyn UT Protect) applied twice weekly for four months. Participants must not have an active infection at entry and will be monitored regularly for recurrence of UTI symptoms during the treatment period. The primary outcome is the proportion of participants who remain free of UTI recurrence at the end of four months of treatment. The trial is sponsored by Karo Pharma AB and conducted at a site in Villeurbanne, France, with eligibility limits including age 18–84 and contraception requirements.

Who should consider this trial

Good fit: Adult women aged 18–84 with uncomplicated recurrent UTIs (≥4 in 12 months or ≥2 in 6 months), not currently infected and willing to follow contraception and visit requirements, are ideal candidates.

Not a fit: Pregnant or nursing women, those with complicated UTIs or a current active infection, recent childbirth within three months, or who do not meet the recurrence criteria are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, the gel could reduce UTI recurrences and lower the need for repeated antibiotic courses, improving quality of life.

How similar studies have performed: Other non-antibiotic, microbiome-targeting approaches such as vaginal estrogen or certain probiotics have shown modest benefit in reducing recurrent UTIs, but evidence for vaginal gels of this type is limited and mixed.

Eligibility criteria

Inclusion Criteria:

1. Age: 18 to 84 years old.
2. Sex: Female.
3. Subject suffering from uncomplicated recurrent urinary tract infections: ≥ 4. UTIs within 12 months or ≥ 2 within 6 months.
4. Subject having given freely and expressly her informed consent.
5. Subject using a contraceptive regimen recognized as effective (pill, implant, Intra Uterine Device (IUD), condoms) since at least 12 weeks before inclusion visit and during the whole study. If subject use condoms as contraceptive regimen, a delay of 6 hours between application and sexual intercourse must be respected.
6. Subject affiliated to a health social security system.
7. Subject cooperative and aware of the device's modalities of use and the necessity and duration of the follow-up visits so that perfect adhesion to the protocol can be expected.

Exclusion Criteria:

1. Pregnant or nursing woman or planning a pregnancy during the study.
2. Subject who gave birth in the 3 previous months.
3. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
4. Subject in a social or sanitary establishment.
5. Subject suspected to be non-compliant according to the investigator's judgment.
6. Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
7. Subject enrolled in another clinical trial or which exclusion period is not over.
8. Subject with history of complicated urinary tract infection.
9. Subject with urinary tract infection at the time of inclusion.
10. Subject with vaginal mycosis infection in the last 3 weeks.
11. Subject with recurrent vaginal mycosis (more than 2 in the last 6 months).
12. Subject having a known allergy or hypersensitivity to one of the components of the investigational device.
13. Subject suffering from a sexually transmitted gynaecological infection or aerobic vaginitis (including gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis).
14. Subject with history of hormone-dependent cancer or bladder cancer.
15. Subject with current genital malignancies.
16. Subject who had a chemotherapy treatment for a cancer in the 12 months before inclusion.
17. Subject who had a radiotherapy treatment in the genito-urinary area in the 12 months before inclusion.
18. Subject using treatment for urinary tract infection, vaginal conditions, vaginal infections, or other intravaginal treatment at the time of inclusion.
19. Subject using food supplements for prevention of urinary tract infection in the last 3 months.
20. Subject using antibiotics, corticoids or antifungal treatment for any reason in the 3 weeks before inclusion.
21. Subject using vaginal douches and who do not wish to refrain using them during the clinical investigation.
22. Subject with a pessary.
23. Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.

Where this trial is running

Villeurbanne

• Eurofins Dermscan Pharmascan — Villeurbanne, France (Recruiting)

Study contacts

• Study coordinator: Diana Zeneli, MD

Conditions Urinary Tract Infections