Recurrent Urinary Tract Infections and Heparin (RUTIH Trial)

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University; University of Oklahoma
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Taking any anticoagulant such as warfarin sodium, heparin

• Taking any thrombolytic agent such as a tissue plasminogen activator or streptokinase

• Known aneurysm, thrombocytopenia, hemorrhagic disease, hemophilia, gastrointestinal ulceration, polyps, or diverticula

• Known hypersensitivity to heparin

• History of, or currently has neurogenic bladder, pelvic irradiation or chemical cystitis

• Presence of urethral, pelvic, or rectal carcinoma, Benign or malignant bladder tumors

• Tuberculous cystitis, urinary schistosomiasis

• Bladder or ureteral calculi, urethral or bladder obstruction, augmentation cystoplasty, cystectomy, supratrigonal denervation of the bladder (cystolysis), neurectomy, or implanted peripheral nerve stimulator that has affected bladder function; Microscopic hematuria as defined as > 5 red blood cells (RBC) /high power field at baseline visit without a negative workup within the last year

• Positive pregnancy test at the baseline visit, are pregnant or lactating, or are planning to become pregnant during the study period

• Have history of uterine, cervical or vaginal cancer during the past 3 years

• Clinically significant vaginitis at baseline visit