Overactive BladderPhase 4NCT03508921
Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection
A Phase 4 study testing Periprocedural Antibiotics, Extended Antibiotics and Injection of OnabotulinumtoxinA (BTX-A) in people with Overactive Bladder and Urinary Tract Infections, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. Urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Urinary Tract Infections
- What is being tested?
- Periprocedural Antibiotics, Extended Antibiotics and Injection of OnabotulinumtoxinA (BTX-A)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Medication refractory OAB, identified per American Urological Association guidelines
Who cannot join
- Post void residual urine >150ml on two occasions
- Untreated, symptomatic UTI
- Comorbid neurological conditions, including spinal cord injury, systemic neurologic illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system disease (i.e. brain tumor, stroke)
- Prior pelvic irradiation
- Current or prior bladder malignancy
- Hematuria lacking a clinically appropriate evaluation
- Chronic indwelling or intermittent catheterization
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial
Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. Urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent these events. While antibiotics are commonly given at the time of injection, the duration of these antibiotic regimens are variable. The investigators propose a study to investigate different antibiotic protocols and their affect on the rate of urinary tract infection after injection.
Read the detailed description
Intravesical injection of OnabotulinumtoxinA (BTX-A) is a widely practiced third line therapy for non-neurogenic overactive bladder (OAB). However, a paucity of data exists regarding urinary tract infections (UTI), the most common adverse event following injection. The investigators propose a randomized, controlled cross-over trial to investigate the utility of commonly practiced antibiotic protocols and simultaneously derive information regarding risk factors for post-procedural UTIs and their affect on treatment efficacy.
The investigators plan to initiate a prospective, randomized non-inferiority cross-over trial, in which a participant receives peri-procedural antibiotics exclusively at the time of one injection, and then at a subsequent injection, completes a three-day course of antibiotics post-operatively in addition to the peri-procedural dose. Enrollment is planned to achieve a total of 68 participants. Participants will be evaluated at 3 weeks and 3 months following injection to identify adverse events and treatment success. Inter-injection time will be measured and used a surrogate for efficacy over multiple injections.
These results, in addition to filling a void in current literature regarding the increasingly utilized treatment with BTX-A, have the potential to modify clinical practice regarding antibiotic use and decrease rates of adverse events. The means to stratify patients based on their specific risk of UTI may be used to facilitate antibiotic stewardship and improve patient outcomes.
- Conditions
- Overactive Bladder, Urinary Tract Infections
- Being tested
- Periprocedural Antibiotics, Extended Antibiotics, Injection of OnabotulinumtoxinA (BTX-A)
- Keywords
- Onabotulinumtoxin
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periprocedural AntibioticsDrug
Also called trimethoprim/sulfamethoxazole
One the day of injection, after eligibility is determined and consent obtained, research staff will refer to the randomization list to determine to which arm the patient is randomized. Patients randomized to the "Procedural Antibiotics Only" arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first injection.
Extended AntibioticsDrug
Also called trimethoprim/sulfamethoxazole
Patients randomized to the "Extended Antibiotics" arm will receive one dose of trimethoprim/sulfamethoxazole peri-procedurally and additionally be prescribed trimethoprim/sulfamethoxazole twice daily for three days. Patients who are allergic will receive amoxicillin/clavulanic acid (875/125mg) twice daily for three days. If allergic to both of the above antibiotics, patients will receive 100mg nitrofurantoin BID for three days.
For their second injection, they will receive peri-procedural antibiotics only.
Injection of OnabotulinumtoxinA (BTX-A)Procedure or surgery
Patients will receive injection of OnabotulinumtoxinA (BTX-A) per standard clinic practice protocol. All patients will undergo injection per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml.
| Study group | Role | What they receive |
|---|---|---|
| Periprocedural Antibiotics Only | Experimental | Patients receive a one-time dose of antibiotics at the time of injection, prior to injection. Receives: Drug: Periprocedural Antibiotics; Procedure: Injection of OnabotulinumtoxinA (BTX-A) |
| Extended Antibiotics | Experimental | Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally. Receives: Drug: Periprocedural Antibiotics; Drug: Extended Antibiotics; Procedure: Injection of OnabotulinumtoxinA (BTX-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Procedural- Urinary Tract Infection
Number of participants with post procedural- urinary tract infection 3 weeks after injections, measured by a urine culture and defined as a urine culture with >10^5 bacterial colonies in the setting of urinary symptoms.
Measured: 3 weeks post-injection
Secondary outcomes (2)
Urinary Retention
Number of participants with urinary retention > 250 cc post-procedurally as measured by post void residual volume using a bladder scanner in clinic.
Measured: 3 weeks post-injection
Recurrent Urinary Tract Infection
Number of participants with 3 or greater post procedural- urinary tract infection after injections, measured by a urine culture and defined as a urine culture with >10^5 bacterial colonies in the setting of urinary symptoms.
Measured: 3 weeks post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Jul 2018
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Why it stopped: Early termination due to recruitment and follow-up challenges during the pandemic
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 Vanderbilt University Medical CenterThe 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Allergan Foundation, Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
- Responsible party
- Principal investigator, Melissa Kaufman, Vanderbilt University Medical Center
- Investigators
- Melissa Kaufman, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508921
- Sponsor's protocol ID
- 00011112222
- Status last verified
- Oct 2023
- First submitted
- 13 Mar 2018
- Last updated
- 2 Nov 2023
- 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 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT03508921
- Acronym / sponsor ID
- 00011112222
- Conditions
- Overactive Bladder, Urinary Tract Infections
- Keywords
- Onabotulinumtoxin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to recruitment and follow-up challenges during the pandemic
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- The Allergan Foundation, Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 2 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. Urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent these events. While antibiotics are commonly given at the time of injection, the duration of these antibiotic regimens are variable. The investigators propose a study to investigate different antibiotic protocols and their affect on the rate of urinary tract infection after injection.
Detailed description
Intravesical injection of OnabotulinumtoxinA (BTX-A) is a widely practiced third line therapy for non-neurogenic overactive bladder (OAB). However, a paucity of data exists regarding urinary tract infections (UTI), the most common adverse event following injection. The investigators propose a randomized, controlled cross-over trial to investigate the utility of commonly practiced antibiotic protocols and simultaneously derive information regarding risk factors for post-procedural UTIs and their affect on treatment efficacy.
The investigators plan to initiate a prospective, randomized non-inferiority cross-over trial, in which a participant receives peri-procedural antibiotics exclusively at the time of one injection, and then at a subsequent injection, completes a three-day course of antibiotics post-operatively in addition to the peri-procedural dose. Enrollment is planned to achieve a total of 68 participants. Participants will be evaluated at 3 weeks and 3 months following injection to identify adverse events and treatment success. Inter-injection time will be measured and used a surrogate for efficacy over multiple injections.
These results, in addition to filling a void in current literature regarding the increasingly utilized treatment with BTX-A, have the potential to modify clinical practice regarding antibiotic use and decrease rates of adverse events. The means to stratify patients based on their specific risk of UTI may be used to facilitate antibiotic stewardship and improve patient outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periprocedural Antibiotics Only | Experimental | Drug: Periprocedural Antibiotics, Procedure: Injection of OnabotulinumtoxinA (BTX-A)Patients receive a one-time dose of antibiotics at the time of injection, prior to injection. |
| Extended Antibiotics | Experimental | Drug: Periprocedural Antibiotics, Drug: Extended Antibiotics, Procedure: Injection of OnabotulinumtoxinA (BTX-A)Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- Medication refractory OAB, identified per American Urological Association guidelines
Key exclusion criteria (7 listed)
- Post void residual urine >150ml on two occasions
- Untreated, symptomatic UTI
- Comorbid neurological conditions, including spinal cord injury, systemic neurologic illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system disease (i.e. brain tumor, stroke)
- Prior pelvic irradiation
- Current or prior bladder malignancy
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 |
|---|---|---|
| Periprocedural AntibioticsAlso: trimethoprim/sulfamethoxazoleOne the day of injection, after eligibility is determined and consent obtained, research staff will refer to the randomization list to determine to which arm the patient is randomized. Patients randomized to the "Procedural Antibiotics Only" arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first injection. | Drug | Extended Antibiotics, Periprocedural Antibiotics Only |
| Extended AntibioticsAlso: trimethoprim/sulfamethoxazolePatients randomized to the "Extended Antibiotics" arm will receive one dose of trimethoprim/sulfamethoxazole peri-procedurally and additionally be prescribed trimethoprim/sulfamethoxazole twice daily for three days. Patients who are allergic will receive amoxicillin/clavulanic acid (875/125mg) twice daily for three days. If allergic to both of the above antibiotics, patients will receive 100mg nitrofurantoin BID for three days. For their second injection, they will receive peri-procedural antibiotics only. | Drug | Extended Antibiotics |
| Injection of OnabotulinumtoxinA (BTX-A)Patients will receive injection of OnabotulinumtoxinA (BTX-A) per standard clinic practice protocol. All patients will undergo injection per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml. | Procedure or surgery | Extended Antibiotics, Periprocedural Antibiotics Only |
Primary outcome
Post Procedural- Urinary Tract Infection
Time frame: 3 weeks post-injection
Number of participants with post procedural- urinary tract infection 3 weeks after injections, measured by a urine culture and defined as a urine culture with >10^5 bacterial colonies in the setting of urinary symptoms.
2 secondary outcomes
Urinary Retention
Time frame: 3 weeks post-injection
Recurrent Urinary Tract Infection
Time frame: 3 weeks post injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- 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.
Melissa Kaufman, MD, PhD principal investigator
Vanderbilt University Medical Center
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 Periprocedural Antibiotics, Extended Antibiotics and Injection of OnabotulinumtoxinA (BTX-A) in people with Overactive Bladder and Urinary Tract Infections, run by Vanderbilt University Medical Center 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 2 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: stopped early, as of the sponsor's last update on 2 Nov 2023. 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 Nov 2023). 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?
Post Procedural- Urinary Tract Infection (time frame: 3 weeks post-injection). 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 Nov 2023.