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Glycosaminoglycan

Heparin for Urinary Tract Infections

Phase 1 & 2
Recruiting
Led By Jameca R. Price, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Known aneurysm, thrombocytopenia, hemorrhagic disease, hemophilia, gastrointestinal ulceration, polyps, or diverticula
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial is testing whether or not heparin bladder instillations can help reduce the number of UTIs a person suffers from.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from the instillation procedure itself and possible bleeding due to heparin's blood-thinning properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had more than 3 UTIs in the last year or 2 in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a known aneurysm or a bleeding disorder.
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I have had surgery or procedures on my bladder or nerves affecting bladder function.
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I have had issues with my bladder due to nerve problems, radiation, or chemical irritation.
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I have a severe vaginal infection.
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I have a bladder condition caused by tuberculosis or a parasitic worm.
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I am currently taking blood thinners like warfarin or heparin.
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I have cancer in my urethra, pelvis, rectum, or bladder.
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I am currently taking medication to break down blood clots.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in UTI rate at 6 months
Secondary study objectives
Change from Baseline in median time to UTI recurrence at 6 months
Other study objectives
Change from Baseline in NGAL levels at 6 months(NGAL) levels after Heparin treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intravesical heparinExperimental Treatment1 Intervention
Recurrent UTI subject receives intravesical heparin once every week for 6 weeks
Group II: PlaceboActive Control1 Intervention
Recurrent UTI subject receives intravesical saline once every week for 6 weeks

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,651 Total Patients Enrolled
Jameca R. Price, MDPrincipal InvestigatorUniversity of Oklahoma

Media Library

Heparin (Glycosaminoglycan) Clinical Trial Eligibility Overview. Trial Name: NCT02246270 — Phase 1 & 2
Urinary Tract Infection Research Study Groups: Placebo, Intravesical heparin
Urinary Tract Infection Clinical Trial 2023: Heparin Highlights & Side Effects. Trial Name: NCT02246270 — Phase 1 & 2
Heparin (Glycosaminoglycan) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02246270 — Phase 1 & 2
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