The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder
NCT ID: NCT05415865
Last Updated: 2022-09-22
Study Results
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Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2022-09-12
2024-05-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Alkalinized Lidocaine, then Placebo
Participants will have Lidocaine Hydrochloride 20 mg/ml, 20 ml and Sodium hydrogen carbonate 1 mmol/ml, 10 ml (ie a total of 30 ml) installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
When signing up for the next BTXA-injection with a wash out period of minimum three months, participants will have the matching placebo containing Sodium Chloride 9 g/L, 20 ml and Sodium Chloride 9 g/L, 10 ml, a total of 30 ml installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
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.
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.
Placebo, then Alkalinized Lidocaine
Participants will have placebo containing Sodium Chloride 9 g/L, 20 ml and Sodium Chloride 9 g/L, 10 ml, a total of 30 ml installed in the bladder 15 minutes prior to the BTXA-injection procedure.
When signing up for the next BTXA-injection with a wash out period of minimum three months, participants will have Lidocaine Hydrochloride 20 mg/ml, 20 ml and Sodium hydrogen carbonate 1 mmol/ml, 10 ml (ie a total of 30 ml) installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Region Hovedstadens Apotek
OTHER_GOV
Herlev and Gentofte Hospital
OTHER
Responsible Party
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Meryam El Issaoui
MD, PhD Student
Principal Investigators
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Niels Klarskov, Prof,MD,DMSc
Role: STUDY_DIRECTOR
Herlev and Gentofte Hospital, University of Copenhagen
Locations
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Kvinde- og Bækkenbundssygdomme, klinik 1
Herlev, Capital Region, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Vaughan CP, Johnson TM 2nd, Ala-Lipasti MA, Cartwright R, Tammela TL, Taari K, Auvinen A, Tikkinen KA. The prevalence of clinically meaningful overactive bladder: bother and quality of life results from the population-based FINNO study. Eur Urol. 2011 Apr;59(4):629-36. doi: 10.1016/j.eururo.2011.01.031. Epub 2011 Jan 25.
Irwin DE, Milsom I, Kopp Z, Abrams P; EPIC Study Group. Symptom bother and health care-seeking behavior among individuals with overactive bladder. Eur Urol. 2008 May;53(5):1029-37. doi: 10.1016/j.eururo.2008.01.027. Epub 2008 Jan 16.
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.
Nambiar AK, Younis A, Khan ZA, Hildrup I, Emery SJ, Lucas MG. Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: A prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity. Neurourol Urodyn. 2016 Apr;35(4):522-7. doi: 10.1002/nau.22750. Epub 2015 Mar 8.
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.
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. doi: 10.1097/00005392-200106000-00014.
Narahashi T, Frazier T, Yamada M. The site of action and active form of local anesthetics. I. Theory and pH experiments with tertiary compounds. J Pharmacol Exp Ther. 1970 Jan;171(1):32-44. No abstract available.
Henry RA, Patterson L, Nickel C, Morales A. Alkalinized intravesical lidocaine to treat interstitial cystitis: absorption kinetics in normal and interstitial cystitis bladders. Urology. 2001 Jun;57(6 Suppl 1):119. doi: 10.1016/s0090-4295(01)01069-x. No abstract available.
Yanagi H, Sankawa H, Saito H, Iikura Y. Effect of lidocaine on histamine release and Ca2+ mobilization from mast cells and basophils. Acta Anaesthesiol Scand. 1996 Oct;40(9):1138-44. doi: 10.1111/j.1399-6576.1996.tb05577.x.
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.
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.
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.
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.
Cote 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. doi: 10.1016/j.jaad.2005.06.011.
Thrasher JB, Peterson NE, Donatucci CF. Lidocaine as a topical anesthetic for bladder biopsies. J Urol. 1991 Jun;145(6):1209-10. doi: 10.1016/s0022-5347(17)38577-4.
Thrasher JB, Kreder KJ, Peterson NE, Donatucci CF. Lidocaine as topical anesthesia for bladder mappings and cold-cup biopsies. J Urol. 1993 Aug;150(2 Pt 1):335-6. doi: 10.1016/s0022-5347(17)35477-0.
Birch BR, Miller RA. Absorption characteristics of lignocaine following intravesical instillation. Scand J Urol Nephrol. 1994 Dec;28(4):359-64. doi: 10.3109/00365599409180513.
El Issaoui M, Elmelund M, Klarskov N. Alkalinised lidocaine as an anaesthetic before onabotulinumtoxinA injections. a randomised trial. BJU Int. 2025 Apr;135(4):638-647. doi: 10.1111/bju.16647. Epub 2025 Jan 11.
Related Links
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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
Other Identifiers
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BTXA2021
Identifier Type: -
Identifier Source: org_study_id
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