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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have had more than 3 UTIs in the last year or 2 in the last 6 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in UTI rate at 6 months
Secondary outcome measures
Change from Baseline in median time to UTI recurrence at 6 months
Other outcome measures
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
455 Previous Clinical Trials
95,893 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to patients who are over the age of 55?

"The age requirements to take part in this clinical trial are between 18-85 years old."

Answered by AI

Are there other historical examples of Intravesical Heparin's efficacy?

"Currently, there are 45 different ongoing studies that are investigating Intravesical Heparin. Out of these, 15 trials are in Phase 3. The majority of clinical trials related to Intravesical Heparin happen in Sherbrooke, Quebec; however, across 389 locations, research teams are conducting similar investigations."

Answered by AI

Could I potentially qualify to join this research project?

"This study requires 30 individuals that have a history of repeated urinary tract infections. The age range for eligible patients is 18 to 85 years old. It's worth mentioning that only women are able to participate and meet the following recurrent UTI definition: having 3 or more symptomatic episodes in the past year, or 2 such episodes within 6 months."

Answered by AI

What benefits does Intravesical Heparin have for patients?

"Intravesical heparin can not only be used to treat medical devices, but also various other conditions such as atrial fibrillation, unstable angina pectoris, and sprains."

Answered by AI

Is this study still looking for participants?

"The trial is recruiting patients at the moment, as stated on clinicaltrials.gov. This information was last updated on 10/31/2022, with the original posting date being 11/28/2017."

Answered by AI

Does this research break new ground in the medical field?

"Since 2006, when the first study on Intravesical Heparin was published, there has been a growing body of research on this topic. In 2006, Ash Access Technology sponsored the initial trial which had 415 participants. After this initial study, Intravesical Heparin received approval for Phase 3 drug trials. As of now, there are 45 ongoing trials involving this medication in 211 cities and 23 countries."

Answered by AI

Who else is applying?

What site did they apply to?
University of Oklahoma-Tulsa OB/GYN Dept and OU-Physicians
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Recurrent Urinary Tract Infections and Heparin (RUTIH Trial)
2017. "Recurrent Urinary Tract Infections and Heparin (RUTIH Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02246270.
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~2 spots leftby Dec 2024
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