Intravesical Gentamicin to Prevent Recurrent UTI

Recurrent Uti Clinical Trial

Official title:

Intravesical Gentamicin to Prevent Recurrent UTI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332781
• Other study ID #: 2126175
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI)

Description:

The overall goal of this project is to assess the feasibility of a larger trial investigating the use of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day). Investigators plan to gain patient perspective regarding preferences for study design and assess associations between the treatments with changes in the postmenopausal urinary microbiome (urobiome).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

• 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.

Related Conditions & MeSH terms

• Recurrence
• Recurrent Uti
• Urinary Tract Infections

Intervention

Drug:
• Gentamicin
administered via bladder
• Nitrofurantoin
administered PO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	urobiome analysis	bacterial presence	3 months, 6 months
Other	urobiome analysis	antimicrobial resistance gene presence	3 months, 6 months
Primary	UTIs	culture-proven UTIs	3 months, 6 months
Secondary	Patient reported outcome measures	UTI Symptom Assessment	3 months, 6 months
Secondary	Patient reported outcome measures	recurrent UTI symptom scale	3 months, 6 months
Secondary	Patient reported outcome measures	recurrent UTI impact questionaire	3 months, 6 months
Secondary	Patient reported outcome measures	short-form-36	3 months, 6 months
Secondary	Patient reported outcome measures	general anxiety disorder-7	3 months, 6 months
Secondary	Patient reported outcome measures	patient health questionnaire	3 months, 6 months