Recurrent Urinary Tract Infections and Heparin (RUTIH Trial)

NCT02246270 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 8481
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in UTI rate at 6 months

  Will measure change from baseline in UTI rate at 6 months using statistical methods

  6 months

Secondary Outcomes (1)

• Change from Baseline in median time to UTI recurrence at 6 months

  6 months

Other Outcomes (1)

• Change from Baseline in NGAL levels at 6 months(NGAL) levels after Heparin treatment

  6 months

Study Arms (2)

Intravesical heparin

EXPERIMENTAL

Recurrent UTI subject receives intravesical heparin once every week for 6 weeks

Drug: Intravesical Heparin

Placebo

ACTIVE COMPARATOR

Recurrent UTI subject receives intravesical saline once every week for 6 weeks

Other: Placebo

Interventions

Intravesical Heparin DRUG

Heparin bladder instillation

Also known as: Intravesical heparin bladder instillation

Intravesical heparin

Placebo OTHER

Intravesical saline

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

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

Tulsa, Oklahoma, 74135, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jameca R. Price, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jameca R Price, MD

CONTACT

918-660-8350; Jameca-Price@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 22, 2014
• Study Start: November 28, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

US (1)