Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections (UTI)

Karo Pharma

Status

Enrolling

Conditions

Urinary Tract Infections (UTIs)

Treatments

Device: Multi-Gyn UT Protect gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT07233473

24-1775-U5

Details and patient eligibility

About

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.

This clinical trial aims to evaluate the safety and effectiveness of Multi-Gyn UT Protect gel in preventing the recurrence of UTIs. The trial will involve 50 adult female participants who have experienced a UTI in recent months but do not currently have an active infection.

Each participant will apply the gel twice a week for four months. They will be monitored throughout this period to assess whether participants develop the reappearance of UTI symptoms.

The primary objective is to determine how many participants do not experience a recurrence of UTI by the end of the four-month treatment period.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 84 years old

Volunteers

Accepts Healthy Volunteers

Inclusion 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 contraceptive regimen, a delay of 6 hours between application and sexual intercourse must be respected.
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.

Exclusion criteria

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.