Recurrent Urinary Tract Infections and Heparin (RUTIH Trial)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Urology |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 9/28/2018 |
| Start Date: | November 28, 2017 |
| End Date: | December 2019 |
| Contact: | Jameca R Price, MD |
| Email: | Jameca-Price@ouhsc.edu |
| Phone: | 918-660-8350 |
Recurrent Urinary Tract Infections and Heparin: a Double-blind Randomized Trial (RUTIH 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.
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.
Primary Objectives: The specific aims of this study are to 1) demonstrate that Heparin
bladder instillations reduce the number of UTI episodes; 2) demonstrate Heparin bladder
instillations increase median intervals between UTI; and 3) demonstrate that Heparin bladder
instillations decrease urine inflammatory (NGAL) levels. Study Design: This study will be a
randomized, double-blind, placebo-controlled trial of subjects treated for documented
recurrent urinary tract infections with heparin bladder instillation versus sterile saline
instillations. The study recruits women (n = 30) with 3 or more UTI episodes in one year from
the patient population at The University of Oklahoma Health Sciences Center (OUHSC) and The
University of Oklahoma-Tulsa (OU-Tulsa) and randomly assigns them to treatment as usual care
with sterile saline instillation (n =15) or treatment as usual with heparin bladder
instillations (n = 15). Subjects are given 6 weekly bladder instillations with interval
follow-ups; the primary outcome measures are number of UTI episodes during the six month
study period and a survival analysis assesses time to the next UTI. The usual care of this
study is antibiotic treatment for UTI only. Urine samples will be collected at certain
intervals. Analysis: We will seek a statistically significant difference of the recurrent UTI
rate for 6 months between heparin instillation and sterile saline instillation group.
Assuming Recurrent UTI rate of sterile saline bladder instillation is 2.3.3 UTI episodes per
six months, a 35% reduction in the recurrent UTI rate is deemed significant based on previous
literature. A sample size 30 (15 for each group) will achieve 60% power to detect a 35%
reduction in recurrent UTI rate at a 0.05 significance level. Allowing for a 25% drop out, a
total of 30 subjects will be required. Significance: Recurrent UTIs are challenging to
manage, especially if microbiological results are equivocal. In women who suffer from
frequent recurrences, daily antibiotic use is the most effective strategy for recurrent UTI
prevention compared to daily cranberry pills, daily estrogen therapy, and acupuncture.
However even with this traditional approach of continuous antibiotic for 6 to 12 months, the
rate of UTI was only reduced during prophylaxis and the rate of UTI was unchanged after
stopping antibiotic treatment. Increasing antibiotic resistance rates require immediate
identification of innovative alternative prophylactic therapies. The lack of non-antibiotic
therapies gives an opportunity to develop innovative strategies to decrease recurrent UTIs
and decrease the burden of UTIs. This study will augment the current evidence available on
the aggregate effects of a treatment that emphasizes the optimization of both antibiotic
regimens and non-antibiotic interventions.
bladder instillations reduce the number of UTI episodes; 2) demonstrate Heparin bladder
instillations increase median intervals between UTI; and 3) demonstrate that Heparin bladder
instillations decrease urine inflammatory (NGAL) levels. Study Design: This study will be a
randomized, double-blind, placebo-controlled trial of subjects treated for documented
recurrent urinary tract infections with heparin bladder instillation versus sterile saline
instillations. The study recruits women (n = 30) with 3 or more UTI episodes in one year from
the patient population at The University of Oklahoma Health Sciences Center (OUHSC) and The
University of Oklahoma-Tulsa (OU-Tulsa) and randomly assigns them to treatment as usual care
with sterile saline instillation (n =15) or treatment as usual with heparin bladder
instillations (n = 15). Subjects are given 6 weekly bladder instillations with interval
follow-ups; the primary outcome measures are number of UTI episodes during the six month
study period and a survival analysis assesses time to the next UTI. The usual care of this
study is antibiotic treatment for UTI only. Urine samples will be collected at certain
intervals. Analysis: We will seek a statistically significant difference of the recurrent UTI
rate for 6 months between heparin instillation and sterile saline instillation group.
Assuming Recurrent UTI rate of sterile saline bladder instillation is 2.3.3 UTI episodes per
six months, a 35% reduction in the recurrent UTI rate is deemed significant based on previous
literature. A sample size 30 (15 for each group) will achieve 60% power to detect a 35%
reduction in recurrent UTI rate at a 0.05 significance level. Allowing for a 25% drop out, a
total of 30 subjects will be required. Significance: Recurrent UTIs are challenging to
manage, especially if microbiological results are equivocal. In women who suffer from
frequent recurrences, daily antibiotic use is the most effective strategy for recurrent UTI
prevention compared to daily cranberry pills, daily estrogen therapy, and acupuncture.
However even with this traditional approach of continuous antibiotic for 6 to 12 months, the
rate of UTI was only reduced during prophylaxis and the rate of UTI was unchanged after
stopping antibiotic treatment. Increasing antibiotic resistance rates require immediate
identification of innovative alternative prophylactic therapies. The lack of non-antibiotic
therapies gives an opportunity to develop innovative strategies to decrease recurrent UTIs
and decrease the burden of UTIs. This study will augment the current evidence available on
the aggregate effects of a treatment that emphasizes the optimization of both antibiotic
regimens and non-antibiotic interventions.
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
We found this trial at
1
site
Tulsa, Oklahoma 74135
Principal Investigator: Jameca R. Price, MD
Phone: 918-660-8350
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