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Prevention study for Urinary Tract Infections (UTIs)
Official title Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections
ClinicalTrials.gov ID: NCT07233473
What this study is testing
- What it's testing
- Urinary Tract Infections (UTIs) are among the most common bacterial infections. Although they are typically treated effectively with antibiotics, recurrence is a frequent and troublesome issue.
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 84, women only. Healthy volunteers may be eligible.
You may be able to join if
- Age: 18 to 84 years old.
- Sex: Female.
- Subject suffering from uncomplicated recurrent urinary tract infections: ≥ 4. UTIs within 12 months or ≥ 2 within 6 months.
- Subject having given freely and expressly her informed consent.
- Subject using a contraceptive regimen recognized as effective (pill, implant, Intra Uterine Device (IUD), condoms) since at least 12 weeks before...
You likely can't join if
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject who gave birth in the 3 previous months.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the...
See the full eligibility criteria
- Age: 18 to 84 years old.
- Sex: Female.
- Subject suffering from uncomplicated recurrent urinary tract infections: ≥ 4. UTIs within 12 months or ≥ 2 within 6 months.
- Subject having given freely and expressly her informed consent.
- 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...
- Subject affiliated to a health social security system.
- 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.
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject who gave birth in the 3 previous months.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
- Subject enrolled in another clinical trial or which exclusion period is not over.
- Subject with history of complicated urinary tract infection.
- Subject with urinary tract infection at the time of inclusion.
- Subject with vaginal mycosis infection in the last 3 weeks.
- Subject with recurrent vaginal mycosis (more than 2 in the last 6 months).
- Subject having a known allergy or hypersensitivity to one of the components of the investigational device.
- Subject suffering from a sexually transmitted gynaecological infection or aerobic vaginitis (including gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis).
- Subject with history of hormone-dependent cancer or bladder cancer.
- Subject with current genital malignancies.
- Subject who had a chemotherapy treatment for a cancer in the 12 months before inclusion.
- Subject who had a radiotherapy treatment in the genito-urinary area in the 12 months before inclusion.
- Subject using treatment for urinary tract infection, vaginal conditions, vaginal infections, or other intravaginal treatment at the time of inclusion.
- Subject using food supplements for prevention of urinary tract infection in the last 3 months.
- Subject using antibiotics, corticoids or antifungal treatment for any reason in the 3 weeks before inclusion.
- Subject using vaginal douches and who do not wish to refrain using them during the clinical investigation.
- Subject with a pessary.
- Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
The study team makes the final eligibility decision.
Where it's taking place
- Villeurbanne, France
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 84 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villeurbanne, France. 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.