Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Antibiotic Prophylaxis Clinical Trial

Official title:

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519072
• Other study ID #: 1889711-1
• Status: Recruiting
• Phase: Phase 4
• Start date: August 16, 2022
• Est. completion date: August 16, 2024

Study information

• Verified date: March 2024
• Source: Atlantic Health System
• Contact: Anastasiya Holubyeva, MD
• Phone: 9739717267
• Email: anastasiya.holubyeva[@]atlantichealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 16, 2024
• Est. primary completion date: August 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• Age = 18

• Patient undergoing bladder Botox treatment

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Antibiotic Prophylaxis

Intervention

Drug:
• Nitrofurantoin
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.

Locations

Country	Name	City	State
United States	Atlantic Health	Morristown	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Atlantic Health System	Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Chapple 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. — View Citation

Eckhardt 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. — View Citation

Hashim 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. — View Citation

Houman 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. — View Citation

Huemer 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. — View Citation

Khan 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. — View Citation

Kuo 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. — View Citation

Lightner 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. — View Citation

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. — View Citation

Sievert 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. — View Citation

Wencewicz 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urinary retention and adverse reactions	Number of participants with reactions to antibiotics and urinary retention	6 weeks
Primary	Urinary tract infections	Number of participants with urinary tract infections	2 weeks post-procedure
Secondary	Urinary tract infections	Number of participants with urinary tract infections	6 weeks post-procedure