INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI (INSTANT)

Mayo Clinic

Status and phase

Withdrawn

Phase 4

Conditions

Urinary Tract Infections

Treatments

Drug: Gentamicin

Drug: Nitrofurantoin

Study type

Interventional

Funder types

Other

Identifiers

NCT03299387

11-002887

Details and patient eligibility

About

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.

Full description

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.