Antibiotic ProphylaxisPhase 4NCT05519072
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA
A Phase 4 study testing Nitrofurantoin in people with Antibiotic Prophylaxis, run by Atlantic Health System at 1 site in United States.
Trial summary
This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Prophylaxis
- What is being tested?
- Nitrofurantoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 16 Aug 2024
- Phase
- Phase 4
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age ≥ 18
- Patient undergoing bladder Botox treatment
Who cannot join
- Pregnant and/or breastfeeding
- Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or post void residual (PVR) > 200 mL, unwillingness or inability to initiate clean intermittent catheterization (CIC) post-treatment if required.
- Contraindication to oral antibiotics - hypersensitivity or allergy
- Inability to take medication by mouth
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
Atlantic Health
Morristown, New Jersey, 07962-1905
Lyudmila Babaev, 862-246-4973, lyudmila.babaev@atlantichealth.org
About this study
Official title: Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial
This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance.
Participants will be randomized to antibiotic or no treatment arm. Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection (UTI) symptoms. They will be called again at 6 weeks for follow up.
Read the detailed description
Single-centered, randomized-controlled trial. Participants will be randomized to antibiotic or no treatment arm. All subjects will obtain a urine culture approximately 14 days before the procedure. Those randomized to the treatment arm will receive oral antibiotics at the discretion of physician in accordance to patient's allergies. Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment.
Technique and dose of Botox injection will be at the discretion of the operating physician. Participants will return for a follow up appointment approximately 2 weeks after treatment as is standard, to check a post void residual. They will be called again at 6 weeks for follow up. The investigators will assess for urinary tract infection symptoms, voiding dysfunction, and other adverse events potentially related to the prophylactic antibiotics. Urine cultures will be collected, when possible, to confirm infection for patients developing symptoms.
For the sample size calculation, the investigators assume an alpha (α) value of 0.05 and a power of 80%. The UTI rate after the bladder Botox procedure is 20% (Chapple et al) and the investigators have chosen a δ of 20%. This was chosen because it was the largest amount the investigators found acceptable to presume the no antibiotic group non-inferior. Using these calculations, 64 persons are needed per study arm. With a 10% drop out rate, a total sample size would equal 140 patients total, with 70 per arm.
If participants are found to meet inclusion criteria, they will be contacted by the study team to assess for desired participation in the study. If the patient is agreeable to participate, a phone or in person consent will be obtained and the patient will be randomized. All participants, regardless of study arm, will have a urine culture collected preoperatively, approximately 14 days before procedure. If found to have a UTI, the participants will be treated accordingly. Those in the no antibiotic treatment arm will not receive any antibiotic prophylaxis and will undergo Botox injection. Those in the treatment arm will receive oral antibiotics prescribed at discretion of physician in accordance to participant's allergies.
The primary concern is the development of adverse side effects to antibiotics. Subjects will be monitored throughout the study for these potential adverse events by screening for symptoms. If an event occurs, the PI will be notified immediately. It will also be reported to the Institutional Review Board (IRB) and to all members of the research team.
- Conditions
- Antibiotic Prophylaxis
- Being tested
- Nitrofurantoin
- Keywords
- Antibiotics, Botox, OnabotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrofurantoinDrug
Also called Trimethoprim/Sulfamethoxazole, Trimethoprim, Cefalexin, Ciprofloxacin
For those randomized to the treatment arm, antibiotics will be prescribed at the discretion of the ordering physician. They will be prescribed only in oral form and in accordance with the patient's allergy profile.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic arm | Experimental | Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. Receives: Drug: Nitrofurantoin |
| No treatment arm | No intervention | No antibiotics administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infections
Number of participants with urinary tract infections
Measured: 2 weeks post-procedure
Secondary outcomes (1)
Urinary tract infections
Number of participants with urinary tract infections
Measured: 6 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start16 Aug 2022
- Primary completion16 Aug 2024 (estimated)
- Study completion16 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Antibiotic ProphylaxisStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Carolyn Botros, Atlantic Health System
- Investigators
- Carolyn Botros, DO, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519072
- Sponsor's protocol ID
- 1889711-1
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, De Ridder D, Jenkins B, Magyar A, Chapple C; 191622-096 Investigators. Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study. J Urol. 2016 Sep;196(3):791-800. doi: 10.1016/j.juro.2016.03.146. Epub 2016 Mar 30.
PubMed 27038769Hashim H, Beusterien K, Bridges JF, Amos K, Cardozo L. Patient preferences for treating refractory overactive bladder in the UK. Int Urol Nephrol. 2015 Oct;47(10):1619-27. doi: 10.1007/s11255-015-1100-3. Epub 2015 Sep 7.
PubMed 26347077Sievert KD, Chapple C, Herschorn S, Joshi M, Zhou J, Nardo C, Nitti VW. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014 Oct;68(10):1246-56. doi: 10.1111/ijcp.12443. Epub 2014 Apr 22.
PubMed 24754838Kuo YC, Kuo HC. Adverse Events of Intravesical OnabotulinumtoxinA Injection between Patients with Overactive Bladder and Interstitial Cystitis--Different Mechanisms of Action of Botox on Bladder Dysfunction? Toxins (Basel). 2016 Mar 16;8(3):75. doi: 10.3390/toxins8030075.
PubMed 26999201Houman J, Moradzadeh A, Patel DN, Asanad K, Anger JT, Eilber KS. What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens. Int Urogynecol J. 2019 May;30(5):701-704. doi: 10.1007/s00192-018-3721-4. Epub 2018 Aug 3.
PubMed 30074062Wencewicz TA. Crossroads of Antibiotic Resistance and Biosynthesis. J Mol Biol. 2019 Aug 23;431(18):3370-3399. doi: 10.1016/j.jmb.2019.06.033. Epub 2019 Jul 6.
PubMed 31288031Huemer M, Mairpady Shambat S, Brugger SD, Zinkernagel AS. Antibiotic resistance and persistence-Implications for human health and treatment perspectives. EMBO Rep. 2020 Dec 3;21(12):e51034. doi: 10.15252/embr.202051034. Epub 2020 Dec 8.
PubMed 33400359Eckhardt SE, Takashima Y, Handler SJ, Tenggardjaja C, Yazdany T. Antibiotic regimen and route of administration do not alter rates of urinary tract infection after intravesical botulinum toxin injection for overactive bladder. Int Urogynecol J. 2022 Mar;33(3):703-709. doi: 10.1007/s00192-021-04691-4. Epub 2021 Feb 16.
PubMed 33594517Lightner DJ, Wymer K, Sanchez J, Kavoussi L. Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis. J Urol. 2020 Feb;203(2):351-356. doi: 10.1097/JU.0000000000000509. Epub 2019 Aug 23.
PubMed 31441676Khan MH, Baldo O, Koenig P, Shaikh N. Use of prophylactic antibiotics for intra-vesicle Botox(R) injection. Neurourol Urodyn. 2017 Mar;36(3):828. doi: 10.1002/nau.23034. Epub 2016 May 13.
PubMed 27177011Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, Thompson C, Zhou J, Haag-Molkenteller C. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013 Aug;64(2):249-56. doi: 10.1016/j.eururo.2013.04.001. Epub 2013 Apr 10.
PubMed 23608668Holubyeva A, Khin K, Gao T, Adair S, Wasenda E, Dhariwal L, Caraballo R, Lozo S, Rutledge J, Botros C. Onabotulinum Toxin A-Led Urinary Tract Infections-Should we Safeguard? A Randomized Controlled Trial. Int Urogynecol J. 2025 Feb;36(2):469-474. doi: 10.1007/s00192-024-06028-3. Epub 2025 Jan 21.
PubMed 39836173
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05519072
- Acronym / sponsor ID
- 1889711-1
- Conditions
- Antibiotic Prophylaxis
- Keywords
- Antibiotics, Botox, OnabotulinumtoxinA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 16 Aug 2024 (estimated)
- Study completion
- 16 Aug 2024 (estimated)
- First posted
- 29 Aug 2022 (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 study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance.
Participants will be randomized to antibiotic or no treatment arm. Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection (UTI) symptoms. They will be called again at 6 weeks for follow up.
Detailed description
Single-centered, randomized-controlled trial. Participants will be randomized to antibiotic or no treatment arm. All subjects will obtain a urine culture approximately 14 days before the procedure. Those randomized to the treatment arm will receive oral antibiotics at the discretion of physician in accordance to patient's allergies. Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment.
Technique and dose of Botox injection will be at the discretion of the operating physician. Participants will return for a follow up appointment approximately 2 weeks after treatment as is standard, to check a post void residual. They will be called again at 6 weeks for follow up. The investigators will assess for urinary tract infection symptoms, voiding dysfunction, and other adverse events potentially related to the prophylactic antibiotics. Urine cultures will be collected, when possible, to confirm infection for patients developing symptoms.
For the sample size calculation, the investigators assume an alpha (α) value of 0.05 and a power of 80%. The UTI rate after the bladder Botox procedure is 20% (Chapple et al) and the investigators have chosen a δ of 20%. This was chosen because it was the largest amount the investigators found acceptable to presume the no antibiotic group non-inferior. Using these calculations, 64 persons are needed per study arm. With a 10% drop out rate, a total sample size would equal 140 patients total, with 70 per arm.
If participants are found to meet inclusion criteria, they will be contacted by the study team to assess for desired participation in the study. If the patient is agreeable to participate, a phone or in person consent will be obtained and the patient will be randomized. All participants, regardless of study arm, will have a urine culture collected preoperatively, approximately 14 days before procedure. If found to have a UTI, the participants will be treated accordingly. Those in the no antibiotic treatment arm will not receive any antibiotic prophylaxis and will undergo Botox injection. Those in the treatment arm will receive oral antibiotics prescribed at discretion of physician in accordance to participant's allergies.
The primary concern is the development of adverse side effects to antibiotics. Subjects will be monitored throughout the study for these potential adverse events by screening for symptoms. If an event occurs, the PI will be notified immediately. It will also be reported to the Institutional Review Board (IRB) and to all members of the research team.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic arm | Experimental | Drug: NitrofurantoinAntibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. |
| No treatment arm | No intervention | –No antibiotics administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Age ≥ 18
- Patient undergoing bladder Botox treatment
Key exclusion criteria (4 listed)
- Pregnant and/or breastfeeding
- Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or post void residual (PVR) > 200 mL, unwillingness or inability to initiate clean intermittent catheterization (CIC) post-treatment if required.
- Contraindication to oral antibiotics - hypersensitivity or allergy
- Inability to take medication by mouth
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 |
|---|---|---|
| NitrofurantoinAlso: Trimethoprim/Sulfamethoxazole, Trimethoprim, Cefalexin, CiprofloxacinFor those randomized to the treatment arm, antibiotics will be prescribed at the discretion of the ordering physician. They will be prescribed only in oral form and in accordance with the patient's allergy profile. | Drug | Antibiotic arm |
Primary outcome
Urinary tract infections
Time frame: 2 weeks post-procedure
Number of participants with urinary tract infections
1 secondary outcome
Urinary tract infections
Time frame: 6 weeks post-procedure
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 27 Mar 2024.
- Background: PubMed 27038769Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, De Ridder D, Jenkins B, Magyar A, Chapple C; 191622-096 Investigators. Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study. J Urol. 2016 Sep;196(3):791-800. doi: 10.1016/j.juro.2016.03.146. Epub 2016 Mar 30.
- Background: PubMed 26347077Hashim H, Beusterien K, Bridges JF, Amos K, Cardozo L. Patient preferences for treating refractory overactive bladder in the UK. Int Urol Nephrol. 2015 Oct;47(10):1619-27. doi: 10.1007/s11255-015-1100-3. Epub 2015 Sep 7.
- Background: PubMed 24754838Sievert KD, Chapple C, Herschorn S, Joshi M, Zhou J, Nardo C, Nitti VW. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014 Oct;68(10):1246-56. doi: 10.1111/ijcp.12443. Epub 2014 Apr 22.
- Background: PubMed 26999201Kuo YC, Kuo HC. Adverse Events of Intravesical OnabotulinumtoxinA Injection between Patients with Overactive Bladder and Interstitial Cystitis--Different Mechanisms of Action of Botox on Bladder Dysfunction? Toxins (Basel). 2016 Mar 16;8(3):75. doi: 10.3390/toxins8030075.
- Background: PubMed 30074062Houman J, Moradzadeh A, Patel DN, Asanad K, Anger JT, Eilber KS. What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens. Int Urogynecol J. 2019 May;30(5):701-704. doi: 10.1007/s00192-018-3721-4. Epub 2018 Aug 3.
- Background: PubMed 31288031Wencewicz TA. Crossroads of Antibiotic Resistance and Biosynthesis. J Mol Biol. 2019 Aug 23;431(18):3370-3399. doi: 10.1016/j.jmb.2019.06.033. Epub 2019 Jul 6.
- Background: PubMed 33400359Huemer M, Mairpady Shambat S, Brugger SD, Zinkernagel AS. Antibiotic resistance and persistence-Implications for human health and treatment perspectives. EMBO Rep. 2020 Dec 3;21(12):e51034. doi: 10.15252/embr.202051034. Epub 2020 Dec 8.
- Background: PubMed 33594517Eckhardt SE, Takashima Y, Handler SJ, Tenggardjaja C, Yazdany T. Antibiotic regimen and route of administration do not alter rates of urinary tract infection after intravesical botulinum toxin injection for overactive bladder. Int Urogynecol J. 2022 Mar;33(3):703-709. doi: 10.1007/s00192-021-04691-4. Epub 2021 Feb 16.
- Background: PubMed 31441676Lightner DJ, Wymer K, Sanchez J, Kavoussi L. Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis. J Urol. 2020 Feb;203(2):351-356. doi: 10.1097/JU.0000000000000509. Epub 2019 Aug 23.
- Background: PubMed 27177011Khan MH, Baldo O, Koenig P, Shaikh N. Use of prophylactic antibiotics for intra-vesicle Botox(R) injection. Neurourol Urodyn. 2017 Mar;36(3):828. doi: 10.1002/nau.23034. Epub 2016 May 13.
- Background: PubMed 23608668Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, Thompson C, Zhou J, Haag-Molkenteller C. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013 Aug;64(2):249-56. doi: 10.1016/j.eururo.2013.04.001. Epub 2013 Apr 10.
- Derived from this study: PubMed 39836173Holubyeva A, Khin K, Gao T, Adair S, Wasenda E, Dhariwal L, Caraballo R, Lozo S, Rutledge J, Botros C. Onabotulinum Toxin A-Led Urinary Tract Infections-Should we Safeguard? A Randomized Controlled Trial. Int Urogynecol J. 2025 Feb;36(2):469-474. doi: 10.1007/s00192-024-06028-3. Epub 2025 Jan 21.
- 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.
Carolyn Botros, DO principal investigator
Atlantic Health System
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 Nitrofurantoin in people with Antibiotic Prophylaxis, run by Atlantic Health System 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 4 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 27 Mar 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?
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 Anastasiya Holubyeva, MD (9739717267, anastasiya.holubyeva@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infections (time frame: 2 weeks post-procedure). 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 NCT05519072, which also lists 12 linked publications.
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 27 Mar 2024.