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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study product | Experimental | Multi-Gyn UT Protect gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Gyn UT Protect gel | Device | Vaginal gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of Multi-Gyn UT Protect gel for the prevention of Urinary Tract Infection (UTI) relapse within 4 months | The number of patients without UTI relapse within 4 months will be summarized in frequency (N) and percentage (%), with a confidential interval CI 95%. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of Multi-Gyn UT Protect gel for the prevention of UTI relapse within 1, 2 and 3 months | The number of patients without UTI relapse within 1, 2, 3 months will be summarized in frequency (N) and percentage (%), with a confidential interval CI 95% by time point. | 1, 2 and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Women only
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Zeneli, MD | Contact | 0031 614706949 | diana.zeneli@karo.com | |
| Harsha Madapura, Ph.D. | Contact | 0046 72156 50 75 | harsha.madapura@karo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Pharmascan | Recruiting | Villeurbanne | 69100 | France |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Vaginal gel
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |