The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder

Overactive Bladder Clinical Trial

Official title:

The Effect of Intravesical Lidocaine Solution Versus Placebo as Anesthesia Prior to Intravesical Injection of Onabotulinum Toxin A. A Randomized, Double-blind, Placebo Controlled Cross-over Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415865
• Other study ID #: BTXA2021
• Status: Recruiting
• Phase: Phase 3
• Start date: September 12, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2022
• Source: Herlev and Gentofte Hospital
• Contact: Meryam El Issaoui, MD
• Phone: +4553252379
• Email: meryam.el.issaoui.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of Lidocaine solution versus placebo (isotonic Sodium Chloride NaCl) disposed inside the urinary bladder as intravesical anesthesia prior to onabotulinum toxin A injections in the treatment of urgency urinary incontinence.

Description:

The aim of the study is to investigate if bladder installed Lidocaine solution have an effect on reported pain during BTX-A injections compared to placebo.

The study participants will be recruited from the existing patient populations enrolled in the BTX-A program of the tertiary Urogynaecological Clinic of Herlev University Hospital.

The participants are randomized to:

1. Active drug: Lidocaine Hydrochloride and Sodium hydrogen carbonate

2. Placebo: Sodium Chloride

The study includes 5 study visits:

Visit 1:

• First treatment day

• Randomization

• Registration of pre-treatment pain relief medications: paracetamol, ibuprofen, or other medications. If pre-treatment pain relief is taken before first treatment, same pain relief should be taken before second treatment day (visit 4) in order to reduce bias

• Registration of antibiotic treatment: current antibiotic treatment or long-term prophylactic antibiotic for prevention of recurrent UTI The participant receives the active treatment or placebo, double-blinded

• The participant is asked to grade the intensity of pain according to VAS score immediately after, and when participant has been dressed after the BTX-A injections

Visit 2 (by telephone):

• Phone consultation 1 week after treatment:

• The participant's experience on the procedure on a 5-point ordinal scale: "1- very unsatisfied", "2- unsatisfied", "3- neither unsatisfied or satisfied", "4- satisfied", "5-very satisfied"

Side effects:

• Questions on symptoms of UTI: dysuria, cloudy urine, pollakiuria, nocturia

• Hematuria

• Inability to empty the bladder

• Other symptoms

(Visit 3:)

• The participant contacts the Clinic for next treatment approximately 6-12 months later

• Sponsor or investigator from the Urogynecological Clinic reach out for the participant asking on symptoms of UUI if the participant has not contacted the clinic within 12 months

Visit 4:

• Second treatment day

• The participant receives the opposite treatment, still double-blinded

• Registration of pre-treatment pain relief medications: paracetamol, ibuprofen, or other medications

• Registration of antibiotic treatment: current antibiotic treatment or long-term prophylactic antibiotic for prevention of recurrent UTI

• The participant is asked to grade the intensity of pain according to VAS score immediately after, and when participant has been dressed after the BTX-A injections

Visit 5(by telephone):

• Phone consultation 1 week after treatment:

• The participant's experience on the procedure on a 5-point scale: "1- very unsatisfied", "2- unsatisfied", "3- neither unsatisfied or satisfied", "4- satisfied", "5-very satisfied"

Side effects:

• Questions on symptoms of UTI: dysuria, cloudy urine, pollakiuria nocturia,

• Hematuria

• Inability to empty the bladder

• Other symptoms

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Female, age =18 years

• Admitted to treatment with BTX-A injections at the Urogynecological Clinic at Herlev Hospital due to UUI

• Able to read and understand Danish

• The female accepts to receive BTX-A injections as an outpatient treatment without the option of receiving sedative drugs

Exclusion criteria:

• BTX-A allergy

• Neurological disorder that may affect bladder function (e.g. Multiple sclerosis or spinal cord inju-ry)

• Neurological disorder with neuromuscular transmission failure (i.e. Mystenia Gravis)

• Ongoing UTI or symptoms of UTI prior to treatment, assessed by principal investigator

• Any other bladder pathology at the time of cystoscopy if identified (includes trauma, stones, tu-mor)

• Pregnancy/breastfeeding women

Related Conditions & MeSH terms

• Anesthesia, Local
• Hematuria
• Overactive Bladder
• Pain, Procedural
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge
• Urinary Tract Infections

Intervention

Combination Product:
• Alkalinized Lidocaine
20 ml of Lidocaine Hydrochloride and 10 ml of Sodium hydrogen carbonate will be pulled up and mixed in a syringe on site, and 30 ml mixed solution in total will afterwards be installed in the bladder with a catheter.

Drug:
• Placebo Sodium Chloride 0.9% Inj
20 ml of Sodium Chloride 9 g/L and 10 ml of Sodium Chloride 9 g/L will be pulled up and mixed in a syringe on site, and 30 ml solution in total will afterwards be installed in the bladder with a catheter.

Locations

Country	Name	City	State
Denmark	Kvinde- og Bækkenbundssygdomme, klinik 1	Herlev	Region Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Region Hovedstadens Apotek

Country where clinical trial is conducted

Denmark, 

References & Publications (18)

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Coté TR, Mohan AK, Polder JA, Walton MK, Braun MM. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005 Sep;53(3):407-15. — View Citation

Dmochowski R, Chapple C, Nitti VW, Chancellor M, Everaert K, Thompson C, Daniell G, Zhou J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. J Urol. 2010 Dec;184(6):2416-22. doi: 10.1016/j.juro.2010.08.021. Epub 2010 Oct 16. — View Citation

Duthie JB, Vincent M, Herbison GP, Wilson DI, Wilson D. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD005493. doi: 10.1002/14651858.CD005493.pub3. Review. — View Citation

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25. Review. — View Citation

Henry R, Patterson L, Avery N, Tanzola R, Tod D, Hunter D, Nickel JC, Morales A. Absorption of alkalized intravesical lidocaine in normal and inflamed bladders: a simple method for improving bladder anesthesia. J Urol. 2001 Jun;165(6 Pt 1):1900-3. — View Citation

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Nickel JC, Moldwin R, Lee S, Davis EL, Henry RA, Wyllie MG. Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. BJU Int. 2009 Apr;103(7):910-8. doi: 10.1111/j.1464-410X.2008.08162.x. Epub 2008 Nov 13. — View Citation

Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14. — 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

Pereira E Silva R, Ponte C, Lopes F, Palma Dos Reis J. Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2471-2479. doi: 10.1002/nau.24519. Epub 2020 Sep 21. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	100 mm Visual Analogue Scale (VAS) score	The maximum pain score reported by using VAS	The participant is handed the VAS in paper form and asked to grade the intensity of pain according to the VAS by making a handwritten mark on the VAS immediately after the BTX-A injections
Secondary	Post-void residual requiring Clean Intermittent Catheterization (CIC)	The participant is contacted after each treatment and asked about any inability to empty the bladder	Phone consultation one week after each treatment
Secondary	Urinary tract infection (UTI)	The participant is contacted after each treatment and asked about symptoms of UTI: Dysuria, cloudy urine, pollakiuria, nocturia	Phone consultation one week after each treatment
Secondary	Hematuria	The participant is contacted after each treatment and asked about blood in the urine	Phone consultation one week after each treatment
Secondary	5-point rating scale	The participant is contacted one week after every treatment and asked about the experience on the procedure. The participant's experience on the procedure on a 5-point ordinal scale: "1- very unsatis-fied", "2- unsatisfied", "3- neither unsatisfied or satisfied", "4- satisfied", "5-very satisfied"	Phone consultation one week after each treatment

External Links

•   Abrams P, Cardozo, L, Wagg, A, Wein, A. (Eds) Incontinence 6th Edition. International Continence Society, Bristol UK,: ICI-ICS.; 2017
•   Incontinence. International Consultation on Incontinence: ICUD; 2017