Heparin treatment for recurrent urinary tract infections
Recurrent Urinary Tract Infections and Heparin: a Double-blind Randomized Trial (RUTIH Trial)
PHASE1; PHASE2 · University of Oklahoma · NCT02246270
This study is testing if heparin treatments can help women with frequent urinary tract infections have fewer episodes and feel better.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | University of Oklahoma (other) |
| Locations | 1 site (Tulsa, Oklahoma) |
| Trial ID | NCT02246270 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of heparin bladder instillations on women suffering from recurrent urinary tract infections (UTIs). It aims to determine if these instillations can reduce the frequency of UTI episodes, increase the time between infections, and lower urine inflammatory markers. The study is designed as a randomized, double-blind, placebo-controlled trial involving 30 women who have experienced multiple UTIs in the past year. Participants will receive either heparin or a placebo (sterile saline) over six weeks, with follow-up assessments to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-85 with a history of recurrent urinary tract infections, defined as three or more episodes in the past year.
Not a fit: Patients currently taking anticoagulants or with certain medical conditions such as known aneurysms or hypersensitivity to heparin may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of recurrent UTIs in women, improving their quality of life.
How similar studies have performed: While the use of heparin for this purpose is novel, previous studies have suggested potential benefits of heparin in reducing UTI rates, indicating a promising area of exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tulsa, Oklahoma
- University of Oklahoma-Tulsa OB/GYN Dept and OU-Physicians — Tulsa, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Jameca R. Price, MD — University of Oklahoma
- Study coordinator: Jameca R Price, MD
- Email: Jameca-Price@ouhsc.edu
- Phone: 918-660-8350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrent Urinary Tract Infections