Using gentamicin in the bladder to prevent recurrent UTIs
Intravesical Gentamicin to Prevent Recurrent UTI
This study is testing if putting gentamicin directly into the bladder can help prevent recurrent urinary tract infections in postmenopausal women better than taking antibiotics by mouth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06332781 on ClinicalTrials.gov |
What this trial studies
This project evaluates the feasibility of using intravesical gentamicin instillation, which involves delivering antibiotics directly into the bladder, compared to the standard oral prophylaxis with nitrofurantoin for preventing recurrent urinary tract infections (UTIs). The study aims to gather patient perspectives on the preferred study design and to explore the impact of these treatments on the postmenopausal urinary microbiome. By assessing these factors, the study seeks to lay the groundwork for a larger trial in the future.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women who have experienced two or more UTIs in the past six months and are seeking antibiotic prophylaxis.
Not a fit: Patients with certain conditions such as Parkinson's disease, renal failure, or those who have had multiple negative urine cultures associated with UTI symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective method for preventing recurrent UTIs in postmenopausal women.
How similar studies have performed: While this approach is novel, other studies have explored antibiotic prophylaxis for UTIs, but the specific use of intravesical gentamicin is less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Postmenopausal * 2 UTIs in 6 months * desire to start antibiotic prophylaxis to prevent UTIs Exclusion criteria: * Parkinsons disease * myasthenia gravis * renal failure * liver failure * bladder pain syndrome * multiple negative urine cultures associated with UTI symptoms (\>/= 3) * bladder Botox treatments in the past * treatment planned for UI and prolapse * unevaluated microscopic hematuria * history of kidney stones * no antibiotics within 4 weeks * most recent weight \<40kg (88.18lbs) * surgically altered urinary tract (urinary diversion, phalloplasty, etc) * allergy or hypersensitivity to either of the study medications or medications in the same family including but not limited to: amikacin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.
Where this trial is running
Providence, Rhode Island
- Women & Infants Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Julia K Shinnick
- Email: jshinnick@wihri.org
- Phone: 401 274 1122
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.