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

Phase 4

Withdrawn

• Conditions: Urinary Tract Infections
• Interventions: Drug: Nitrofurantoin; Drug: Gentamicin

• Registration Number: NCT03299387
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2017-06-28
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Primary Completion: 2018-07-05
• Study Completion: 2018-07-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Nitrofurantoin	Nitrofurantoin	Participants will randomized to oral nitrofurantoin
Intravesical Gentamicin	Gentamicin	Participants will be randomized to intravesical gentamicin

Primary Outcome Measures

Name	Time	Method
Change in microbiologic effect of a chronic acute Urinary Tract Infection	baseline, 7-10 days	Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days
Change in symptomatic relief of a chronic acute Urinary Tract Infection	baseline, 7-10 days	Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot)

Secondary Outcome Measures

Name	Time	Method
To establish the clinical FTE needs for providing urgent intravesical treatments	baseline, through stufy completion, an average of one year	Nursing needs to provide intravesical treatments of acute Urinary Tract Infections (UTI) in women with chronic recurrent UTIs. Measured in amount of participants and FTE requirement for nursing staff.