Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

NCT05519072 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1889711-1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antibiotic Prophylaxis

Keywords

Antibiotics; Botox; OnabotulinumtoxinA

Outcome Measures

Primary Outcomes (1)

• Urinary tract infections

  Number of participants with urinary tract infections

  2 weeks post-procedure

Secondary Outcomes (1)

• Urinary tract infections

  6 weeks post-procedure

Other Outcomes (1)

• Urinary retention and adverse reactions

  6 weeks

Study Arms (2)

Antibiotic arm

EXPERIMENTAL

Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment.

Drug: Nitrofurantoin

No treatment arm

NO INTERVENTION

No antibiotics administered.

Interventions

Nitrofurantoin DRUG

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.

Also known as: Trimethoprim/Sulfamethoxazole, Trimethoprim, Cefalexin, Ciprofloxacin, Augmentin, Fosfomycin

Antibiotic arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age ≥ 18
• Patient undergoing bladder Botox treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead
• Columbia University: collaborator

Study Sites (1)

Atlantic Health

Morristown, New Jersey, 07962-1905, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 27038769 BACKGROUND

• 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.

  PMID: 26347077 BACKGROUND

• 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.

  PMID: 24754838 BACKGROUND

• 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.

  PMID: 26999201 BACKGROUND

• 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.

  PMID: 30074062 BACKGROUND

• 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.

  PMID: 31288031 BACKGROUND

• 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.

  PMID: 33400359 BACKGROUND

• 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.

  PMID: 33594517 BACKGROUND

• 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.

  PMID: 31441676 BACKGROUND

• 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.

  PMID: 27177011 BACKGROUND

• 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.

  PMID: 23608668 BACKGROUND

MeSH Terms

Interventions

Nitrofurantoin; Trimethoprim, Sulfamethoxazole Drug Combination; Trimethoprim; Cephalexin; Ciprofloxacin; Amoxicillin-Potassium Clavulanate Combination; Fosfomycin

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Drug Combinations; Pharmaceutical Preparations; Cephalosporins; beta-Lactams; Lactams; Thiazines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Clavulanic Acid; Clavulanic Acids; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Organophosphonates; Organophosphorus Compounds

Study Officials

• Carolyn Botros, DO

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasiya Holubyeva, MD

CONTACT

9739717267; anastasiya.holubyeva@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Program Director FPMRS Fellowship, Principal Investigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: August 16, 2022
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)