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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-84
SponsorKaro Pharma AB

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Multi-Gyn UT Protect gel

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators