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NCT04831840 Clinical Trial

Recurrent Urinary Tract Infections and the Microbiome

Recurrent Urinary Tract Infection Clinical Trial

Official title:
Is PCR Amplification More Sensitive Than Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Recurrent Bladder Infections?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04831840
Other study ID # 20201198
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 26, 2021
Est. completion date June 1, 2024

Study information
Verified date April 2023
Source University of Miami
Contact Laura Martin, DO
Phone 3052436590
Email lem114@med.miami.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective is to determine if polymerase chain reaction (PCR) (UTIP™) is more sensitive in identifying urinary tract infections (UTI's) than standard urine cultures.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 18 y/o-90 y/o - Able to consent - Female - Group A only: Recurrent UTI (2 UTIs in 6 months) - Group B only: No history of recurrent UTIs Exclusion Criteria: - Pregnant - Pelvic radiation - Urinary retention (>200 ml residual) - Greater than Stage 2 prolapse - Renal calculi - Immunosuppressed - Neurologic disorder with significant bladder impairment - No current UTI via dip stick

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Holy Cross Hospital Fort Lauderdale Florida
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of uropathogens The proportion of uropathogens found on PCR versus urine culture from urine samples. Day 1
Primary Proportion of patients negative for repeat testing The proportion of negative patient on repeat testing of urine samples. Up to 4 weeks
See also
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Completed NCT01958073 - Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women Phase 4
Recruiting NCT05652374 - Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study Phase 4
Recruiting NCT06124820 - RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections N/A
Recruiting NCT04807894 - Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo Phase 4
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Recruiting NCT04859621 - Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections Phase 2
Withdrawn NCT03854396 - Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women Phase 3
Completed NCT02705495 - Acupuncture for Prevention of Recurrent Urinary Tract Infections. N/A
Active, not recruiting NCT05537519 - Phage Therapy for the Treatment of Urinary Tract Infection Phase 1/Phase 2
Recruiting NCT06035601 - EHR-integrated rUTI Texting Platform N/A
Not yet recruiting NCT04285320 - Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections Phase 4
Recruiting NCT03142295 - Controlled Human Urine Transfusion for UTI N/A
Recruiting NCT05895578 - Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection. N/A
Completed NCT00214045 - Rigid Versus Flexible Cystoscopy in Women N/A
Enrolling by invitation NCT05551949 - Preventing Recurrent UTI With Vaginal Estrogen Phase 4
Recruiting NCT05472779 - Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections Phase 2