RECRUITING

Recurrent Urinary Tract Infections and Heparin (RUTIH Trial)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Recurrent Urinary Tract Infections and Heparin: a Double-blind Randomized Trial (RUTIH Trial)

Quick Facts

Study Start:2017-11-28

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02246270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Jameca R Price, MD

CONTACT

918-660-8350

Jameca-Price@ouhsc.edu

Principal Investigator

Jameca R. Price, MD

PRINCIPAL_INVESTIGATOR

University of Oklahoma

Study Locations (Sites)

University of Oklahoma-Tulsa OB/GYN Dept and OU-Physicians

Tulsa, Oklahoma, 74135

United States

Collaborators and Investigators

Sponsor: University of Oklahoma

Jameca R. Price, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-11-28

Study Completion Date2024-12

Study Record Updates

Study Start Date2017-11-28

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Urinary Tract Infections