Recurrent UtiPhase 4NCT06332781
Intravesical Gentamicin to Prevent Recurrent UTI
A Phase 4 study testing Gentamicin and Nitrofurantoin in people with Recurrent Uti, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
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) Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Uti
- What is being tested?
- Gentamicin and Nitrofurantoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal
- 2 UTIs in 6 months
- desire to start antibiotic prophylaxis to prevent UTIs
Who cannot join
- Parkinsons disease
- myasthenia gravis
- renal failure
- liver failure
- bladder pain syndrome
- multiple negative urine cultures associated with UTI symptoms (>/= 3)
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02903
About this study
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)
Read the detailed 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).
- Conditions
- Recurrent Uti
- Being tested
- Gentamicin, Nitrofurantoin
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentamicinDrug
administered via bladder
NitrofurantoinDrug
administered PO
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care Receives: Drug: Nitrofurantoin |
| Experimental | Experimental | Gentamicin Receives: Drug: Gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess feasibility of trial recruitment
measure screening ratio (number of people screened versus number enrolled)
Measured: 3 months
Examine treatment compliance
compare medication compliance between groups, as measured by weekly self-reported number of doses taken in the oral medication group and attendance at installation visits in the intravesical gentamicin group
Measured: 3 months
Examine trial retention
compare the proportion of participants retained in each group
Measured: 3 months
Secondary outcomes (7)
culture-proven UTIs
Measured: 3 months
Patient reported outcome measures
UTI Symptom Assessment
Measured: 6 weeks, 3 months
Patient reported outcome measures
recurrent UTI symptom scale
Measured: 6 weeks, 3 months
Patient reported outcome measures
recurrent UTI impact questionaire
Measured: 6 weeks, 3 months
Patient reported outcome measures
short-form-36
Measured: 6 weeks, 3 months
Patient reported outcome measures
general anxiety disorder-7
Measured: 6 weeks, 3 months
Patient reported outcome measures
patient health questionnaire
Measured: 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start28 Apr 2025
- Primary completion30 Sep 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent UtiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332781
- Sponsor's protocol ID
- 2126175 // CTR grant U54GM1156
- Status last verified
- Apr 2026
- First submitted
- 13 Dec 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Gentamicin to Prevent Recurrent UTI
- ClinicalTrials.gov ID
- NCT06332781
- Acronym / sponsor ID
- 2126175 // CTR grant U54GM1156
- Conditions
- Recurrent Uti
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: NitrofurantoinStandard of care |
| Experimental | Experimental | Drug: GentamicinGentamicin |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal
- 2 UTIs in 6 months
- desire to start antibiotic prophylaxis to prevent UTIs
Key exclusion criteria (14 listed)
- Parkinsons disease
- myasthenia gravis
- renal failure
- liver failure
- bladder pain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentamicinadministered via bladder | Drug | Experimental |
| Nitrofurantoinadministered PO | Drug | Standard of Care |
Primary outcome
Assess feasibility of trial recruitment
Time frame: 3 months
measure screening ratio (number of people screened versus number enrolled)
Examine treatment compliance
Time frame: 3 months
compare medication compliance between groups, as measured by weekly self-reported number of doses taken in the oral medication group and attendance at installation visits in the intravesical gentamicin group
Examine trial retention
Time frame: 3 months
compare the proportion of participants retained in each group
7 secondary outcomes
culture-proven UTIs
Time frame: 3 months
Patient reported outcome measures
Time frame: 6 weeks, 3 months
Patient reported outcome measures
Time frame: 6 weeks, 3 months
Patient reported outcome measures
Time frame: 6 weeks, 3 months
Patient reported outcome measures
Time frame: 6 weeks, 3 months
Patient reported outcome measures
Time frame: 6 weeks, 3 months
Patient reported outcome measures
Time frame: 6 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Recurrent Uti
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
RecruitingPhase 3
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Recurrent Urinary Tract Infections in Women
Active, not recruiting
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Recurrent Urinary Tract Infection
RecruitingPhase 4
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gentamicin and Nitrofurantoin in people with Recurrent Uti, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess feasibility of trial recruitment (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.