Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02246270
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2014-09-15
Brief Title:
Recurrent Urinary Tract Infections and Heparin RUTIH Trial
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Recurrent Urinary Tract Infections and Heparin a Double-blind Randomized Trial RUTIH Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 233 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None