Overactive BladderPhase 4NCT05719285
Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
A Phase 4 study testing Single-Dose Antibiotic and Multi-Dose Antibiotic in people with Overactive Bladder and Overactive Bladder Syndrome, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence
- What is being tested?
- Single-Dose Antibiotic and Multi-Dose Antibiotic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 8 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with planned in-office bladder onabotulinumtoxinA injection
- Men or Women Age ≥ 18
- Able to read, speak, and write in English
- No contraindication to injection of onabotulinumtoxinA - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
- Willingness and ability to initiate intermittent catheterization post-treatment if required
- No contraindication to oral antibiotics
- No active antibiotic therapy for any indication at the time of onabotulinumtoxinA injection
- Have not participated in this study before
Who cannot join
- Any type of catheterization to empty the bladder
- Unwillingness or inability to initiate intermittent catheterization post-treatment if required
- Less than 3 months since last bladder onabotulinumtoxinA injection
- Pregnant and/or breastfeeding
- Active symptomatic UTI the day of the procedure - new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills
- History of recurrent UTI
- Prior development of urinary retention or incomplete bladder emptying after bladder onabotulinumtoxinA injection requiring catheterization of any type
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Dose Versus Multi-Dose Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder.
The main question it aims to answer are:
- Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics?
Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection.
Researchers will compare incidence of UTI in each group to see if there is a significant difference.
Read the detailed description
- After informed consent is obtained, urinalysis will be collected. Post-void residual will also be assessed by bladder scan if not already documented in the electronic medical record in the prior three months.
- Patients with positive urinalysis and symptomatic for UTI will be excluded from the study.
- Patients will be randomized in a 1:1 ratio to one of two groups.
- Group 1 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.
- Group 2 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.
- The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy.
- Bladder onabotulinumtoxinA injection and dosing will be completed based on the surgeon's standard technique and template.
- Bladder onabotulinumtoxinA injection will be completed by staff or fellows in the Female Pelvic Medicine and Reconstructive Surgery division of the Genitourinary and Kidney Institute.
- Patients will be followed for 4 weeks after the procedure.
- At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period.
- Chart review will occur at 4 weeks to assess for any unreported events.
- Other than this additional phone call, post-operative patient management will not deviate from the standard of care.
- Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators.
- Patients that report symptoms suggestive of a UTI will result in obtaining a urine culture.
- Symptomatic, culture proven UTIs will be treated with appropriate antibiotics per the current AUA guidelines.
- Symptoms suggestive of urinary retention, such as increased urinary frequency, voiding small amounts of urine, or feelings of incomplete bladder emptying, will result in obtaining a post void residual (PVR) and urinalysis.
- Patients will undergo teaching to perform self, clean intermittent catheterization of the bladder per the discretion of the operating surgeon.
- Any adverse reactions to the prescribed antibiotic will result in discontinuation of the antibiotic and managed according to the severity of the reaction.
Antibiotic regimens:
Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth.
First line:
Group 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Group 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses
Second line:
Group 1: cefalexin 500 mg once pre-procedure Group 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Third line:
Group 1: nitrofurantoin 100 mg once pre-procedure Group 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses
Fourth line:
Group 1: ciprofloxacin 500 mg once pre-procedure Group 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence, Urge
- Being tested
- Single-Dose Antibiotic, Multi-Dose Antibiotic
- Keywords
- incontinence, overactive bladder, urge incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Dose AntibioticDrug
Also called ARM 1: Single-Dose Antibiotic Prophylaxis
Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth.
First line:
Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure
Second line:
Arm 1: cefalexin 500 mg once pre-procedure
Third line:
Arm 1: nitrofurantoin 100 mg once pre-procedure
Fourth line:
Arm 1: ciprofloxacin 500 mg once pre-procedure
Multi-Dose AntibioticDrug
Also called ARM 2: Multi-Dose Antibiotic Prophylaxis
Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth.
First line:
Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses
Second line:
Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Third line:
Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses
Fourth line:
Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
| Study group | Role | What they receive |
|---|---|---|
| 1: Single-Dose Antibiotic Prophylaxis | Active comparator | Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. Receives: Drug: Single-Dose Antibiotic |
| 2: Multi-Dose Antibiotic Prophylaxis | Active comparator | Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. Receives: Drug: Multi-Dose Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration.
To assess this aim, the rate of postoperative urinary tract infection (UTI) within 4 weeks following bladder onabotulinumtoxinA injection will be compared between groups. Noninferiority will be declared if the incidence of UTI in the single dose group is not more than UTI incidence in the multiple dose group within statistical variability, by the prespecified noninferiority margin.
Measured: 4 weeks
Secondary outcomes (2)
Antibiotic Adverse Events
Summarize rates of adverse events related to antibiotics in each group.
Measured: 4 weeks
Symptomatic Urinary Retention
Estimate the rate of symptomatic urinary retention requiring catheterization among refractory overactive bladder patients who experience a UTI.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start6 Dec 2022
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Model description
- Men and women 18 years of age or older with refractory overactive bladder or neurogenic bladder will be randomized in a 1:1 ratio into one of two groups until the targeted sample size is met: * The single dose group will receive one dose of antibiotic prior to intradetrusor Botox injection. * Individuals in the multi-dose group will receive one dose of antibiotic prior to intradetrusor Botox injection and additional antibiotics for a total of three days of antibiotic administration. Random permuted block randomization with block sizes of 2, 4, 6, and 8 will be used to assign eligible patients to treatment groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Slopnick, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719285
- Sponsor's protocol ID
- 22-698
- Status last verified
- Sep 2023
- First submitted
- 23 Jan 2023
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Versus Multi-Dose Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
- ClinicalTrials.gov ID
- NCT05719285
- Acronym / sponsor ID
- 22-698
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence, Urge
- Keywords
- incontinence, overactive bladder, urge incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Posted 2 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder.
The main question it aims to answer are:
- Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics?
Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection.
Researchers will compare incidence of UTI in each group to see if there is a significant difference.
Detailed description
- After informed consent is obtained, urinalysis will be collected. Post-void residual will also be assessed by bladder scan if not already documented in the electronic medical record in the prior three months.
- Patients with positive urinalysis and symptomatic for UTI will be excluded from the study.
- Patients will be randomized in a 1:1 ratio to one of two groups.
- Group 1 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.
- Group 2 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.
- The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy.
- Bladder onabotulinumtoxinA injection and dosing will be completed based on the surgeon's standard technique and template.
- Bladder onabotulinumtoxinA injection will be completed by staff or fellows in the Female Pelvic Medicine and Reconstructive Surgery division of the Genitourinary and Kidney Institute.
- Patients will be followed for 4 weeks after the procedure.
- At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period.
- Chart review will occur at 4 weeks to assess for any unreported events.
- Other than this additional phone call, post-operative patient management will not deviate from the standard of care.
- Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators.
- Patients that report symptoms suggestive of a UTI will result in obtaining a urine culture.
- Symptomatic, culture proven UTIs will be treated with appropriate antibiotics per the current AUA guidelines.
- Symptoms suggestive of urinary retention, such as increased urinary frequency, voiding small amounts of urine, or feelings of incomplete bladder emptying, will result in obtaining a post void residual (PVR) and urinalysis.
- Patients will undergo teaching to perform self, clean intermittent catheterization of the bladder per the discretion of the operating surgeon.
- Any adverse reactions to the prescribed antibiotic will result in discontinuation of the antibiotic and managed according to the severity of the reaction.
Antibiotic regimens:
Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth.
First line:
Group 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Group 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses
Second line:
Group 1: cefalexin 500 mg once pre-procedure Group 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Third line:
Group 1: nitrofurantoin 100 mg once pre-procedure Group 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses
Fourth line:
Group 1: ciprofloxacin 500 mg once pre-procedure Group 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Men and women 18 years of age or older with refractory overactive bladder or neurogenic bladder will be randomized in a 1:1 ratio into one of two groups until the targeted sample size is met: * The single dose group will receive one dose of antibiotic prior to intradetrusor Botox injection. * Individuals in the multi-dose group will receive one dose of antibiotic prior to intradetrusor Botox injection and additional antibiotics for a total of three days of antibiotic administration. Random permuted block randomization with block sizes of 2, 4, 6, and 8 will be used to assign eligible patients to treatment groups
| Arm | Type | Receives |
|---|---|---|
| 1: Single-Dose Antibiotic Prophylaxis | Active comparator | Drug: Single-Dose AntibioticPatients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. |
| 2: Multi-Dose Antibiotic Prophylaxis | Active comparator | Drug: Multi-Dose AntibioticPatients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with planned in-office bladder onabotulinumtoxinA injection
- Men or Women Age ≥ 18
- Able to read, speak, and write in English
- No contraindication to injection of onabotulinumtoxinA - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
- Willingness and ability to initiate intermittent catheterization post-treatment if required
Key exclusion criteria (7 listed)
- Any type of catheterization to empty the bladder
- Unwillingness or inability to initiate intermittent catheterization post-treatment if required
- Less than 3 months since last bladder onabotulinumtoxinA injection
- Pregnant and/or breastfeeding
- Active symptomatic UTI the day of the procedure - new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills
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 |
|---|---|---|
| Single-Dose AntibioticAlso: ARM 1: Single-Dose Antibiotic ProphylaxisAllergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure | Drug | 1: Single-Dose Antibiotic Prophylaxis |
| Multi-Dose AntibioticAlso: ARM 2: Multi-Dose Antibiotic ProphylaxisAllergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses | Drug | 2: Multi-Dose Antibiotic Prophylaxis |
Primary outcome
Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration.
Time frame: 4 weeks
To assess this aim, the rate of postoperative urinary tract infection (UTI) within 4 weeks following bladder onabotulinumtoxinA injection will be compared between groups. Noninferiority will be declared if the incidence of UTI in the single dose group is not more than UTI incidence in the multiple dose group within statistical variability, by the prespecified noninferiority margin.
2 secondary outcomes
Antibiotic Adverse Events
Time frame: 4 weeks
Symptomatic Urinary Retention
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Emily Slopnick, MD principal investigator
The Cleveland Clinic
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 Single-Dose Antibiotic and Multi-Dose Antibiotic in people with Overactive Bladder and Overactive Bladder Syndrome, run by The Cleveland Clinic 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 8 inclusion and 7 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 2 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration. (time frame: 4 weeks). 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 2 Jan 2024.