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| Name | Class |
|---|---|
| Region Hovedstadens Apotek | OTHER_GOV |
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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.
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:
The study includes 5 study visits:
Visit 1:
Visit 2 (by telephone):
Side effects:
(Visit 3:)
Visit 4:
Visit 5(by telephone):
Side effects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alkalinized Lidocaine, then Placebo | Active Comparator | 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. |
|
| Placebo, then Alkalinized Lidocaine | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alkalinized Lidocaine | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Urinary tract infection (UTI) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meryam El Issaoui, MD | Contact | +4553252379 | meryam.el.issaoui.01@regionh.dk | |
| Niels Klarskov, Prof,MD,DMSc | Contact | +4538681406 | niels.klarskov@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Niels Klarskov, Prof,MD,DMSc | Herlev and Gentofte Hospital, University of Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kvinde- og Bækkenbundssygdomme, klinik 1 | Recruiting | Herlev | Capital Region | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19937315 | Background | 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. | |
| 21306820 |
| Label | URL |
|---|---|
| Abrams P, Cardozo, L, Wagg, A, Wein, A. (Eds) Incontinence 6th Edition. International Continence Society, Bristol UK,: ICI-ICS.; 2017 | View source |
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The study is a randomized, controlled, double-blinded, crossover study. The participants are their own control in the evaluation of the effect of intravesical alkalinized Lidocaine solution versus placebo as anesthesia prior to intravesical injection of onabotulinum toxin A. The chosen model is advantageous as a smaller sample size is needed, and error variance is reduced.
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Region Hovedstadens Apotek, Herlev Hospital produces the Lidocaine solution and the matching placebo solution, performs the randomization, and packages the blinded dosing kits with the order of Lidocaine and placebo in a balanced design (50% Lidocaine at the first treatment). Participants will get consecutive randomization numbers, which specify the dosing kit. Neither the participant, the operator, or the healthcare professional interviewing the participant about her pain score know what solution the participant gets administered.
| Placebo Sodium Chloride 0.9% Inj | Drug | 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. |
|
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 |
| Hematuria | The participant is contacted after each treatment and asked about blood in the urine | Phone consultation one week after each treatment |
| 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 |
| 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. |
| 18243515 | Background | 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. |
| 27038769 | Background | 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. |
| 25754188 | Background | 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. |
| 19021619 | Background | 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. |
| 11371877 | Background | 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. |
| 5410936 | Background | 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. |
| 11378101 | Background | 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. |
| 8933856 | Background | 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. |
| 32956506 | Background | 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. |
| 23246476 | Background | 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. |
| 22161392 | Background | 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;2011(12):CD005493. doi: 10.1002/14651858.CD005493.pub3. |
| 20952013 | Background | 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. |
| 16112345 | Background | 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. |
| 2033694 | Background | 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. |
| 8326556 | Background | 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. |
| 7886411 | Background | 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. |
| 39797697 | Derived | 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. |
| Incontinence. International Consultation on Incontinence: ICUD; 2017 | View source |
| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| D000073818 | Pain, Procedural |
| D014552 | Urinary Tract Infections |
| D006417 | Hematuria |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D007239 | Infections |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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