Clinical trial NCT03299387: INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI
Official title: INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: urinary tract
infection
recurrent
women
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in microbiologic effect of a chronic acute Urinary Tract Infection
timeFrame: baseline, 7-10 days
measure: Change in symptomatic relief of a chronic acute Urinary Tract Infection
timeFrame: baseline, 7-10 days
Secondary outcomes:
measure: To establish the clinical FTE needs for providing urgent intravesical treatments
timeFrame: baseline, through stufy completion, an average of one year
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Deborah Lightner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Audrey N Schuetz, MD
role: PRINCIPAL_INVESTIGATOR
References: