INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/5/2017 |
| Start Date: | June 28, 2017 |
| End Date: | July 14, 2019 |
| Contact: | Deborah J Lightner, MD |
| Email: | lightner.deborah@mayo.edu |
| Phone: | 507-284-6784 |
INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)
Women have problems with oral antibiotics, including vagina and bowel infections. Also,
bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement
of antibiotic directly into the bladder does not cause these problems and are at doses that
are may be able to stop bacteria from being resistant to antibiotics.
bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement
of antibiotic directly into the bladder does not cause these problems and are at doses that
are may be able to stop bacteria from being resistant to antibiotics.
Each participant once enrolled returns with an active Urinary Tract Infection (UTI),
confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent
with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin
treatment for 7 days, or intravesical gentamicin instillation once a day for three days.
Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and
with a repeated questionnaire for symptom relief.
confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent
with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin
treatment for 7 days, or intravesical gentamicin instillation once a day for three days.
Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and
with a repeated questionnaire for symptom relief.
Inclusion Criteria:
- Ability to understand study procedures and to comply with them for the entire length
of the study.
Exclusion Criteria:
- Patients who report that they are pregnant.
- Patients with a positive urine pregnancy test
- Patients with a history of renal transplantation.
- Patients with bladder augmentation procedures using bowel.
- Patients with poorly controlled Type II diabetes, Hgb A1C >6.5%
- Patients with spinal cord injury, ASIA Impairment Scale of C or higher.
- Patients with pelvic surgery within 6 months.
- Patients with urologic procedure within 6 months.
- Patients with a history of reconstructive urologic surgery, such as reflux, congenital
abnormality.
- Immunocompromised patients being treated for malignancy or a history of actively
treated malignancy within 5 years.
- Patients with active systemic autoimmune disease.
- Patients on systemic immunosuppression.
- Use of antibiotic prophylaxis within 6 months
- Use of antibiotics within 10 days of active infection
- Allergy/sensitivity to gentamicin or nitrofurantoin.
- Current drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual to give written informed consent.
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Deborah Lightner, MD
Phone: 507-284-6784
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