Antibiotic StewardshipNCT04754737
Antibiotic Usage Prior to OnabotulinumtoxinA Injection
A study testing No antibiotic, Prophylactic antibiotic and cystoscopic injection of onabotulinumtoxinA in people with Antibiotic Stewardship and Overactive Bladder, run by Benaroya Research Institute at 1 site in United States.
Trial summary
Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for 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
- Antibiotic Stewardship, Overactive Bladder, Onabotulinumtoxin A
- What is being tested?
- No antibiotic, Prophylactic antibiotic and cystoscopic injection of onabotulinumtoxinA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18
- Diagnosis of OAB who have failed 1st and 2nd line therapies per the AUA/SUFU OAB guidelines (including bladder training, dietary modification and pharmacotherapy with an anticholinergic and/or beta-3 agonist)
- Not symptomatic for UTI at the time of injection
- Negative urinalysis at the time of the injection defined as: negative for nitrites and leukocyte esterace, with urine white blood cell count less than 5 per high-power field
- Consent to participate in the study.
Who cannot join
- Antibiotic usage within 48 hours prior to intradetrusor onabotulinumtoxinA injection
- Women who are pregnant or planning to become pregnant, women who are breastfeeding
- Concurrent use of onabotulinumtoxinA injection with maximum cumulative dose exceeding 400 units in a 3-month interval.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook Medicine
Stony Brook, New York, 11794
Justina Tam, MD, 631-444-1910
About this study
Official title: Optimizing Antibiotic Use in Treatment of Overactive Bladder: Evaluating the Need for Prophylactic Antibiotics Prior to OnabotulinumtoxinA Injection in Patients Without Urinary Tract Infection
Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onabotulinumtoxinA is currently standard of care of patients with OAB who have persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure. However, these recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate. A previously published prospective study demonstrated that the rate of post-procedural UTI did not differ amongst patients with neurogenic bladder who did not receive prophylactic antibiotics and were asymptomatic for UTI, regardless of whether they had sterile urine cultures or asymptomatic bacteriuria, suggesting that patients who are not symptomatic for UTI may not require antibiotic prophylaxis prior to intradetrusor onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal/allergic and gastro-intestinal manifestations. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally evaluate the differences in UTI frequency in subjects who have a negative urinalysis and are not symptomatic for UTI and receive prophylactic antibiotics at the time of intradetrusor onabotulinumtoxinA injection compared to those who do not receive prophylactic antibiotics at the time of injection. The proposed study seeks to evaluate the current practice standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.
Read the detailed description
Intradetrusor injection of onabotulinumtoxinA, which is performed thorough a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for OAB. Intradetrusor of onabotulinumtoxinA is currently standard of care in patients with persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure as the current standard of care. However, the guideline recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate, and does not address cystoscopic injection procedures like onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal/allergic and gastro-intestinal manifestations. In an effort to optimize antibiotic usage, antimicrobial stewardship is required in nursing facilities, acute-care and critical care hospitals, as well as ambulatory care centers. These efforts highlight the importance of re-evaluating our current practice standard of prophylactic antibiotic administration in urologic procedures. A prospective study that included patients undergoing intradetrusor onabutulinumtoxin injections who were not symptomatic for UTI and did not receive antibiotic prophylaxis demonstrated that the rate of post-procedure UTI within 6 weeks of treatment was not significantly different in those with a sterile urine culture compared to those with asymptomatic bacteriuria, suggesting that in patients who are not symptomatic for UTI, antibiotic prophylaxis may not be necessary prior to intradetrusor onabotulinumtoxin injection. To date, there have been no randomized studies that evaluate differences in outcomes when prophylactic antibiotics are not given prior to onabotulinumtoxinA injection. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally investigate whether there is a difference in the rate of symptomatic post-procedure UTI after intradetrusor onabotulinumtoxin when antibiotic prophylaxis is given compared to when antibiotic prophylaxis is not given in patients who are not symptomatic for UTI and have a negative urinalysis. The proposed study seeks to evaluate the current practice standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.
- Conditions
- Antibiotic Stewardship, Overactive Bladder, Onabotulinumtoxin A, UTI
- Being tested
- No antibiotic, Prophylactic antibiotic, cystoscopic injection of onabotulinumtoxinA
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No antibioticOther
No antibiotics will be given prior to intravesical injection of onabotulinumtoxinA
Prophylactic antibioticOther
This is the current standard of care, this group of patients will be given a single dose of prophylactic antibiotic prior to the injection of onabotulinumtoxinA via cystoscopy
cystoscopic injection of onabotulinumtoxinAProcedure or surgery
cystoscopic injection of onabotulinumtoxinA
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic antibiotic | Other | These patients will receive the current standard of care, which is to receive a single dose of prophylactic antibiotics just prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy. The specific prophylactic antibiotics will vary depending on patient's prior urine culture sensitivities and patient medication allergies/sensitivities and medical comorbidities. Receives: Other: Prophylactic antibiotic; Procedure: cystoscopic injection of onabotulinumtoxinA |
| No antibiotics | Experimental | These patients will receive no prophylactic antibiotics prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy. Receives: Other: No antibiotic; Procedure: cystoscopic injection of onabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic UTI
the number of symptomatic UTIs which occur within the 14 day period after cystoscopic intradetrusor injection of onabotulinumtoxinA
Measured: 14 days
Secondary outcomes (2)
Percentage of subjective improvement in overactive bladder symptoms
Patient reported percentage of subjective improvement
Measured: 14-30 days
Rate of adverse events including dysuria, gross hematuria, and urinary retention
Patient reported adverse events
Measured: 14-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start23 Mar 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic StewardshipStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, un-blinded
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, Stony Brook University, Northwell Health, Virginia Mason Hospital/Medical Center
- Responsible party
- Sponsor
- Investigators
- Justina Tam, MD, Principal investigator, Stony Brook Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754737
- Sponsor's protocol ID
- IRB20-101
- Status last verified
- Apr 2024
- First submitted
- 7 Feb 2021
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to other researchers who are not involved in the study.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antibiotic Use in Treatment of Overactive Bladder: Evaluating the Need for Prophylactic Antibiotics Prior to OnabotulinumtoxinA Injection in Patients Without Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT04754737
- Acronym / sponsor ID
- IRB20-101
- Conditions
- Antibiotic Stewardship, Overactive Bladder, Onabotulinumtoxin A, UTI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, Stony Brook University, Northwell Health, Virginia Mason Hospital/Medical Center
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Feb 2021 (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.
Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onabotulinumtoxinA is currently standard of care of patients with OAB who have persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure. However, these recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate. A previously published prospective study demonstrated that the rate of post-procedural UTI did not differ amongst patients with neurogenic bladder who did not receive prophylactic antibiotics and were asymptomatic for UTI, regardless of whether they had sterile urine cultures or asymptomatic bacteriuria, suggesting that patients who are not symptomatic for UTI may not require antibiotic prophylaxis prior to intradetrusor onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal/allergic and gastro-intestinal manifestations. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally evaluate the differences in UTI frequency in subjects who have a negative urinalysis and are not symptomatic for UTI and receive prophylactic antibiotics at the time of intradetrusor onabotulinumtoxinA injection compared to those who do not receive prophylactic antibiotics at the time of injection. The proposed study seeks to evaluate the current practice standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.
Detailed description
Intradetrusor injection of onabotulinumtoxinA, which is performed thorough a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for OAB. Intradetrusor of onabotulinumtoxinA is currently standard of care in patients with persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure as the current standard of care. However, the guideline recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate, and does not address cystoscopic injection procedures like onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal/allergic and gastro-intestinal manifestations. In an effort to optimize antibiotic usage, antimicrobial stewardship is required in nursing facilities, acute-care and critical care hospitals, as well as ambulatory care centers. These efforts highlight the importance of re-evaluating our current practice standard of prophylactic antibiotic administration in urologic procedures. A prospective study that included patients undergoing intradetrusor onabutulinumtoxin injections who were not symptomatic for UTI and did not receive antibiotic prophylaxis demonstrated that the rate of post-procedure UTI within 6 weeks of treatment was not significantly different in those with a sterile urine culture compared to those with asymptomatic bacteriuria, suggesting that in patients who are not symptomatic for UTI, antibiotic prophylaxis may not be necessary prior to intradetrusor onabotulinumtoxin injection. To date, there have been no randomized studies that evaluate differences in outcomes when prophylactic antibiotics are not given prior to onabotulinumtoxinA injection. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally investigate whether there is a difference in the rate of symptomatic post-procedure UTI after intradetrusor onabotulinumtoxin when antibiotic prophylaxis is given compared to when antibiotic prophylaxis is not given in patients who are not symptomatic for UTI and have a negative urinalysis. The proposed study seeks to evaluate the current practice standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, un-blinded
| Arm | Type | Receives |
|---|---|---|
| Prophylactic antibiotic | Other | Other: Prophylactic antibiotic, Procedure: cystoscopic injection of onabotulinumtoxinAThese patients will receive the current standard of care, which is to receive a single dose of prophylactic antibiotics just prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy. The specific prophylactic antibiotics will vary depending on patient's prior urine culture sensitivities and patient medication allergies/sensitivities and medical comorbidities. |
| No antibiotics | Experimental | Other: No antibiotic, Procedure: cystoscopic injection of onabotulinumtoxinAThese patients will receive no prophylactic antibiotics prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Diagnosis of OAB who have failed 1st and 2nd line therapies per the AUA/SUFU OAB guidelines (including bladder training, dietary modification and pharmacotherapy with an anticholinergic and/or beta-3 agonist)
- Not symptomatic for UTI at the time of injection
- Negative urinalysis at the time of the injection defined as: negative for nitrites and leukocyte esterace, with urine white blood cell count less than 5 per high-power field
- Consent to participate in the study.
Key exclusion criteria (3 listed)
- Antibiotic usage within 48 hours prior to intradetrusor onabotulinumtoxinA injection
- Women who are pregnant or planning to become pregnant, women who are breastfeeding
- Concurrent use of onabotulinumtoxinA injection with maximum cumulative dose exceeding 400 units in a 3-month interval.
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 |
|---|---|---|
| No antibioticNo antibiotics will be given prior to intravesical injection of onabotulinumtoxinA | Other | No antibiotics |
| Prophylactic antibioticThis is the current standard of care, this group of patients will be given a single dose of prophylactic antibiotic prior to the injection of onabotulinumtoxinA via cystoscopy | Other | Prophylactic antibiotic |
| cystoscopic injection of onabotulinumtoxinAcystoscopic injection of onabotulinumtoxinA | Procedure or surgery | No antibiotics, Prophylactic antibiotic |
Primary outcome
symptomatic UTI
Time frame: 14 days
the number of symptomatic UTIs which occur within the 14 day period after cystoscopic intradetrusor injection of onabotulinumtoxinA
2 secondary outcomes
Percentage of subjective improvement in overactive bladder symptoms
Time frame: 14-30 days
Rate of adverse events including dysuria, gross hematuria, and urinary retention
Time frame: 14-30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No. IPD will not be made available to other researchers who are not involved in the study.
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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.
Justina Tam, MD principal investigator
Stony Brook Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No antibiotic, Prophylactic antibiotic and cystoscopic injection of onabotulinumtoxinA in people with Antibiotic Stewardship and Overactive Bladder, run by Benaroya Research Institute 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 May 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justina Tam, MD (6314441910, justina.tam@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic UTI (time frame: 14 days). 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 24 May 2024.