Recurrent Urinary Tract InfectionPhase 4NCT04285320
Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections
A Phase 4 study testing Intravesical antibiotic instillation and Antibiotic oral suppressive therapy in people with Recurrent Urinary Tract Infection, run by Atlantic Health System.
Trial summary
This is a research study that aims to determine if antibiotic bladder instillations (placing an antibiotic directly into the bladder) over several sessions at the office is a good option to prevent recurrent urinary tract infections, in comparison with oral suppression therapy (taking daily antibiotics in the form of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Intravesical antibiotic instillation and Antibiotic oral suppressive therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Apr 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-menopausal women with recurrent urinary tract infections (2 infections in a 6-month period or at least 3 infections in a 1-year period)
- Receiving estrogen vaginal therapy for 1 month prior to enrollment
- Able to come in to the office twice weekly for 3-4 weeks
- English speaking
- No allergy to at least one of the three antibiotics used for bladder instillations and at least one of the four antibiotics recommended for oral suppressive therapy.
- No uro-pathogen resistance to at least one of the three antibiotics used for bladder instillations and at least one of the four antibiotics recommended for oral suppressive therapy.
Who cannot join
- Allergy to all study antibiotics (Gentamicin, Tobramycin, Amikacin, Trimethoprim/sulfamethoxazole, Fosfomycin, Nitrofurantoin and Cephalexin)
- Recent Urine culture with pathogens resistant to all study antibiotics (Gentamicin, Tobramycin, Amikacin, Trimethoprim/sulfamethoxazole, Fosfomycin, Nitrofurantoin and Cephalexin)
- Renal failure (Creatinine clearance <30ml/min)
- History of urinary retention
- History of genitourinary structural abnormalities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intravesical Antibiotic Instillations Versus Oral Suppression for the Treatment of Recurrent Urinary Tract Infections in Post-menopausal Women
This is a research study that aims to determine if antibiotic bladder instillations (placing an antibiotic directly into the bladder) over several sessions at the office is a good option to prevent recurrent urinary tract infections, in comparison with oral suppression therapy (taking daily antibiotics in the form of pills by mouth). Oral antibiotic suppression therapy is currently the most common treatment route for recurrent urinary tract infections in post-menopausal women. The bladder antibiotic instillation may overcome the disadvantages of oral suppression therapy such as antibiotic resistance, certain side effects, and recurrence of infections after finishing the treatment course.
Read the detailed description
In this study, the investigators aim to determine the effectiveness of intra-vesical antibiotic instillations for the prophylactic treatment of recurrent urinary tract infections in menopausal women in comparison with oral suppressive therapy. This is a parallel un-blinded randomized-controlled trial. the investigators will randomize post-menopausal women with recurrent urinary tract infections to either receive 6-8 intra-vesical antibiotic instillations at the office or to receive 3 months of oral antibiotic suppressive therapy.
In the bladder instillation arm, based on the participant's allergy and antibiotic resistance profile, one of the following three antibiotics will be instilled intravesically via a latex free BARD® 12 French Foley catheter for a total of 6-8 instillations (2 instillations/week) according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol:
- Amikacin-30 mg in 60 ml of sterile water
- Gentamycin-80mg in 60ml sterile water
- Tobramycin-80 mg in 100 ml of sterile water
In the antibiotic oral suppression therapy arm, one of the following routinely used antibiotics will be prescribed for a total of 3 months according to the American Urogynecology Society Guidelines and based on the participant's allergy and antibiotic resistance profile:
- Trimethoprim daily (100 mg)
- Trimethoprim/sulfamethoxazole daily (40 mg/200 mg)
- Trimethoprim/sulfamethoxazole every 3 days (40 mg/200 mg)
- Nitrofurantoin monohydrate/macrocrystals daily (50 mg)
- Nitrofurantoin monohydrate/macrocrystals daily (100 mg)
- Cephalexin daily (125 mg)
- Cephalexin daily (250 mg)
- Fosfomycin every 10 days (3 grams) All medications used in this study are approved by the FDA to treat urinary tract infections.
Participants will be followed for total of 3 months after finishing either treatment course by only reviewing their medical records to collect data regarding development of urinary tract infections after treatment.
Primary endpoint/outcome:
- To compare the number of women developing urinary tract infections during the 3 months following treatment between the two groups.
Secondary endpoints/outcomes:
- To compare the rate of antibiotic resistance of isolated pathogens after intravesical antibiotic instillation vs. oral antibiotic suppressive therapy
- To compare side effects of the two treatment modalities
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Intravesical antibiotic instillation, Antibiotic oral suppressive therapy
- Keywords
- Antibiotic bladder instillation, Intravesical antibiotic instillation, Oral suppressive therapy, Recurrent UTI
- 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.
Intravesical antibiotic instillationDrug
Based on the participant's allergy and antibiotic resistance profile, one of the following three antibiotics will be instilled intravesically via a latex free BARD® 12 French Foley catheter for a total of 6-8 instillations (2 instillations/week) according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol:
- Amikacin-30 mg in 60 ml of sterile water
- Gentamycin-80mg in 60ml sterile water
- Tobramycin-80 mg in 100 ml of sterile water
Antibiotic oral suppressive therapyDrug
In the antibiotic oral suppression therapy arm, one of the following routinely used antibiotics will be prescribed for a total of 3 months according to the American Urogynecology Society Guidelines and based on the participant's allergy and antibiotic resistance profile:
- Trimethoprim daily (100 mg)
- Trimethoprim/sulfamethoxazole daily (40 mg/200 mg)
- Trimethoprim/sulfamethoxazole every 3 days (40 mg/200 mg)
- Nitrofurantoin monohydrate/macrocrystals daily (50 mg)
- Nitrofurantoin monohydrate/macrocrystals daily (100 mg)
- Cephalexin daily (125 mg)
- Cephalexin daily (250 mg)
- Fosfomycin every 10 days (3 grams)
| Study group | Role | What they receive |
|---|---|---|
| Intravesical antibiotic instillation | Active comparator | Not described Receives: Drug: Intravesical antibiotic instillation |
| Oral antibiotic suppressive therapy | Active comparator | Not described Receives: Drug: Antibiotic oral suppressive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants with urinary tract infections following treatment course
To compare the percentage of women developing urinary tract infections during the 3 months following treatment between the two groups.
Measured: Assessed starting immediately after the treatment is completed for a total of 3 months.
Secondary outcomes (2)
The rate of antibiotic resistance of pathogens in participants developing urinary tract infections after completing the treatment course.
To compare the rate of antibiotic resistance of isolated pathogens when participants develop a urinary tract infection during the 3 months follow up period after intra-vesical antibiotic instillation vs. oral antibiotic suppressive therapy. the percentage of antibiotics on the susceptibility list of urine cultures will be compared between participants developing urinary tract infection in each group during the 3 months follow-up period after completing the treatment.
Measured: Assessed starting immediately after the treatment is completed for a total of 3 months
the percentage of patients developing side effects of the 2 treatments
To compare the percentage of patients developing side effects between the two treatment modalities. At their routine follow up visits patients will be asked about whether or not they developed side effects and the type and severity of side effects of the treatment received. The percentage of patients developing side effects (per type and severity) in each arm will be compared.
Measured: From the date of randomization until the date of first documented side effect assessed up to 3 months after the treatment is completed in each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study startMar 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Urinary Tract InfectionStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, charbel salamon, Atlantic Health System
- Investigators
- Charbel Salamon, MD, MS, Principal investigator, Atlantic Health System - Morristown Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285320
- Sponsor's protocol ID
- 1565199
- Status last verified
- Jan 2021
- First submitted
- 17 Feb 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chernyak S, Salamon C. Intravesical Antibiotic Administration in the Treatment of Recurrent Urinary Tract Infections: Promising Results From a Case Series. Female Pelvic Med Reconstr Surg. 2020 Feb;26(2):152-154. doi: 10.1097/SPV.0000000000000810.
PubMed 31990805
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Antibiotic Instillations Versus Oral Suppression for the Treatment of Recurrent Urinary Tract Infections in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT04285320
- Acronym / sponsor ID
- 1565199
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- Antibiotic bladder instillation, Intravesical antibiotic instillation, Oral suppressive therapy, Recurrent UTI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 26 Feb 2020 (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.
This is a research study that aims to determine if antibiotic bladder instillations (placing an antibiotic directly into the bladder) over several sessions at the office is a good option to prevent recurrent urinary tract infections, in comparison with oral suppression therapy (taking daily antibiotics in the form of pills by mouth). Oral antibiotic suppression therapy is currently the most common treatment route for recurrent urinary tract infections in post-menopausal women. The bladder antibiotic instillation may overcome the disadvantages of oral suppression therapy such as antibiotic resistance, certain side effects, and recurrence of infections after finishing the treatment course.
Detailed description
In this study, the investigators aim to determine the effectiveness of intra-vesical antibiotic instillations for the prophylactic treatment of recurrent urinary tract infections in menopausal women in comparison with oral suppressive therapy. This is a parallel un-blinded randomized-controlled trial. the investigators will randomize post-menopausal women with recurrent urinary tract infections to either receive 6-8 intra-vesical antibiotic instillations at the office or to receive 3 months of oral antibiotic suppressive therapy.
In the bladder instillation arm, based on the participant's allergy and antibiotic resistance profile, one of the following three antibiotics will be instilled intravesically via a latex free BARD® 12 French Foley catheter for a total of 6-8 instillations (2 instillations/week) according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol:
- Amikacin-30 mg in 60 ml of sterile water
- Gentamycin-80mg in 60ml sterile water
- Tobramycin-80 mg in 100 ml of sterile water
In the antibiotic oral suppression therapy arm, one of the following routinely used antibiotics will be prescribed for a total of 3 months according to the American Urogynecology Society Guidelines and based on the participant's allergy and antibiotic resistance profile:
- Trimethoprim daily (100 mg)
- Trimethoprim/sulfamethoxazole daily (40 mg/200 mg)
- Trimethoprim/sulfamethoxazole every 3 days (40 mg/200 mg)
- Nitrofurantoin monohydrate/macrocrystals daily (50 mg)
- Nitrofurantoin monohydrate/macrocrystals daily (100 mg)
- Cephalexin daily (125 mg)
- Cephalexin daily (250 mg)
- Fosfomycin every 10 days (3 grams) All medications used in this study are approved by the FDA to treat urinary tract infections.
Participants will be followed for total of 3 months after finishing either treatment course by only reviewing their medical records to collect data regarding development of urinary tract infections after treatment.
Primary endpoint/outcome:
- To compare the number of women developing urinary tract infections during the 3 months following treatment between the two groups.
Secondary endpoints/outcomes:
- To compare the rate of antibiotic resistance of isolated pathogens after intravesical antibiotic instillation vs. oral antibiotic suppressive therapy
- To compare side effects of the two treatment modalities
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravesical antibiotic instillation | Active comparator | Drug: Intravesical antibiotic instillation |
| Oral antibiotic suppressive therapy | Active comparator | Drug: Antibiotic oral suppressive therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Post-menopausal women with recurrent urinary tract infections (2 infections in a 6-month period or at least 3 infections in a 1-year period)
- Receiving estrogen vaginal therapy for 1 month prior to enrollment
- Able to come in to the office twice weekly for 3-4 weeks
- English speaking
- No allergy to at least one of the three antibiotics used for bladder instillations and at least one of the four antibiotics recommended for oral suppressive therapy.
Key exclusion criteria (5 listed)
- Allergy to all study antibiotics (Gentamicin, Tobramycin, Amikacin, Trimethoprim/sulfamethoxazole, Fosfomycin, Nitrofurantoin and Cephalexin)
- Recent Urine culture with pathogens resistant to all study antibiotics (Gentamicin, Tobramycin, Amikacin, Trimethoprim/sulfamethoxazole, Fosfomycin, Nitrofurantoin and Cephalexin)
- Renal failure (Creatinine clearance <30ml/min)
- History of urinary retention
- History of genitourinary structural abnormalities
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 |
|---|---|---|
| Intravesical antibiotic instillationBased on the participant's allergy and antibiotic resistance profile, one of the following three antibiotics will be instilled intravesically via a latex free BARD® 12 French Foley catheter for a total of 6-8 instillations (2 instillations/week) according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol: * Amikacin-30 mg in 60 ml of sterile water * Gentamycin-80mg in 60ml sterile water * Tobramycin-80 mg in 100 ml of sterile water | Drug | Intravesical antibiotic instillation |
| Antibiotic oral suppressive therapyIn the antibiotic oral suppression therapy arm, one of the following routinely used antibiotics will be prescribed for a total of 3 months according to the American Urogynecology Society Guidelines and based on the participant's allergy and antibiotic resistance profile: * Trimethoprim daily (100 mg) * Trimethoprim/sulfamethoxazole daily (40 mg/200 mg) * Trimethoprim/sulfamethoxazole every 3 days (40 mg/200 mg) * Nitrofurantoin monohydrate/macrocrystals daily (50 mg) * Nitrofurantoin monohydrate/macrocrystals daily (100 mg) * Cephalexin daily (125 mg) * Cephalexin daily (250 mg) * Fosfomycin every 10 days (3 grams) | Drug | Oral antibiotic suppressive therapy |
Primary outcome
The percentage of participants with urinary tract infections following treatment course
Time frame: Assessed starting immediately after the treatment is completed for a total of 3 months.
To compare the percentage of women developing urinary tract infections during the 3 months following treatment between the two groups.
2 secondary outcomes
The rate of antibiotic resistance of pathogens in participants developing urinary tract infections after completing the treatment course.
Time frame: Assessed starting immediately after the treatment is completed for a total of 3 months
the percentage of patients developing side effects of the 2 treatments
Time frame: From the date of randomization until the date of first documented side effect assessed up to 3 months after the treatment is completed in each arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 31990805Chernyak S, Salamon C. Intravesical Antibiotic Administration in the Treatment of Recurrent Urinary Tract Infections: Promising Results From a Case Series. Female Pelvic Med Reconstr Surg. 2020 Feb;26(2):152-154. doi: 10.1097/SPV.0000000000000810.
- Individual participant dataSharing planned: No
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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.
Charbel Salamon, MD, MS principal investigator
Atlantic Health System - Morristown Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravesical antibiotic instillation and Antibiotic oral suppressive therapy in people with Recurrent Urinary Tract Infection, run by Atlantic Health System.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Sabatino, MPH (973-971-7361, caroline.sabatino@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of participants with urinary tract infections following treatment course (time frame: Assessed starting immediately after the treatment is completed for a total of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04285320, which also lists 1 linked publication.
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 14 Jan 2021.