Recurrent Urinary Tract Infections and Heparin: a Double-blind Randomized Trial (RUTIH Trial)

Who is this study for? Adult female patients with recurrent urinary tract infection
What treatments are being studied? Intravesical Heparin
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Urinary Tract Infections (UTIs) are the second most common infection in the body. UTIs account for five percent of all visits to primary care physicians. Many women who have had a UTI will develop recurring urinary tract infections. Recent studies suggest that some women who suffer from recurrent UTIs have urinary tracts that allow bacteria to adhere to it more readily than others. Women who suffered from bladder inflammation and recurrent UTIs were noted to have reduced UTIs and bladder inflammation with heparin bladder instillations. Heparin is a highly-sulfated glycosaminoglycan and stored within the secretory granules of mast cells and released only into the vasculature at sites of tissue injury. It has been proposed that, in addition to anticoagulation, the main purpose of heparin is defense at such sites against invading bacteria and other foreign materials. The central question the research is intended to answer is does Heparin bladder instillations decrease UTI rates in patients.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Women aged 18-85 with history of recurrent urinary tract infections.

‣ Definition of Recurrent UTI: if experienced either more than 3 symptomatic UTI episodes in the past year (including the index infection) or 2 such episodes in the past 6 months.

⁃ Definition of UTI: \>103 cfu/mL of a uropathogen in midstream urine culture from a woman experiencing more than 2 symptoms of cystitis (dysuria, urgency, frequency, suprapubic pain, or hematuria) or, in the absence of a culture, demonstration of pyuria on urinalysis and more than 2 urinary symptoms, as well as complete and rapid resolution of symptoms in response to antibiotic therapy for UTI.

Locations
United States
Oklahoma
University of Oklahoma-Tulsa OB/GYN Dept and OU-Physicians
RECRUITING
Tulsa
Contact Information
Primary
Jameca R Price, MD
Jameca-Price@ouhsc.edu
918-660-8350
Time Frame
Start Date: 2017-11-28
Estimated Completion Date: 2024-12
Participants
Target number of participants: 30
Treatments
Experimental: Intravesical heparin
Recurrent UTI subject receives intravesical heparin once every week for 6 weeks
Active_comparator: Placebo
Recurrent UTI subject receives intravesical saline once every week for 6 weeks
Related Therapeutic Areas
Sponsors
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov

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