Heparin for Urinary Tract Infections

Recruiting in Palo Alto (17 mi)

Overseen by Jameca R. Price, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Oklahoma

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jameca R. Price, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for women aged 18-85 who have had more than three UTIs in the past year or at least two in six months. Participants must not be on blood thinners, pregnant, or have a history of certain bladder issues and cancers. They should also not have any known allergies to heparin.

Inclusion Criteria

I have had more than 3 UTIs in the last year or 2 in the last 6 months.

I have had a UTI with symptoms that improved quickly with antibiotics.

I am a woman aged 18-85 and have had multiple urinary tract infections.

Exclusion Criteria

I have a known aneurysm or a bleeding disorder.

I have had surgery or procedures on my bladder or nerves affecting bladder function.

I have had issues with my bladder due to nerve problems, radiation, or chemical irritation.

Treatment Details

Interventions

• Heparin (Glycosaminoglycan)

Trial Overview The RUTIH Trial is testing whether Heparin bladder instillations can reduce the rate of recurrent urinary tract infections (UTIs) in women prone to them compared to a placebo group.

Participant Groups

Group I: Intravesical heparin Experimental Treatment 1 Intervention

Recurrent UTI subject receives intravesical heparin once every week for 6 weeks

Group II: Placebo Active Control 1 Intervention

Recurrent UTI subject receives intravesical saline once every week for 6 weeks

Heparin is already approved in Canada for the following indications:

Approved in Canada as Heparin sodium for:

• Prevention of thromboembolic disorders
• Treatment of deep vein thrombosis
• Treatment of pulmonary embolism

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Dr. Scott Rollins

University of Oklahoma

Chief Executive Officer since 2016

PhD in Immunology from the University of Oklahoma

Dr. Ondria Gleason

University of Oklahoma

Chief Medical Officer

MD from the University of Oklahoma College of Medicine