Efficacy and Safety of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women with Overactive Bladder and the Value of Local Anesthesia: A randomized Clinical Study

Overview

Journal Wien Klin Wochenschr

Publisher Springer

Specialty General Medicine

Date 2024 Aug 23

PMID 39179906

Authors

Niko Kavcic

Andrej Avsenak

Jan Zmazek

Tamara Serdinsek

Igor But

Affiliations

Soon will be listed here.

Abstract

Background: A non-inferiority clinical study evaluated the efficacy and safety of abobotulinumtoxinA vs. incobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence. Also, the effect of local anesthesia on the pain level of the procedure was assessed.

Methods: Patients were randomized to receive 20 intradetrusor injections of either 300 U abobotulinumtoxinA or 100 U incobotulinumtoxinA. They were further randomized to receive either local anesthesia (40 ml 1% lidocaine solution) or placebo before botulinum toxin injection. Before the procedure and 4 months after the procedure each patient reported urinary incontinence episodes, frequency, nocturia, completed the Urogenital Distress Inventory (UDI-6) score, Incontinence Impact Questionnaire (IIQ-7), and Incontinence Quality of Life (I-QOL) questionnaire. Each patient completed a patient satisfaction survey 4 months after the procedure. During the procedure, the patients graded the pain intensity of every injection on a visual analog scale (VAS). The total score of each questionnaire was considered.

Results: A total of 54 patients with a mean age of 66 ± 13 (SD) years completed the study. Total scores of UDI‑6, IIQ‑7, I‑QOL, patient satisfaction, urinary incontinence episodes, frequency, nocturia and VAS questionnaires did not show differences between the abobotulinumtoxinA (n = 26) or incobotulinumtoxinA (n = 28) group. Urinary retention requiring catheterization was noted in five patients. The VAS and patient satisfaction questionnaire values did not show significant differences between the group receiving bladder instillation with lidocaine solution (n = 28) or the group receiving placebo (n = 26).

Conclusion: In women with overactive bladder and urge urinary incontinence where conservative treatment failed, abobotulinumtoxinA vs. incobotulinumtoxinA intradetrusor injections showed comparable results regarding improved clinical outcome and patient satisfaction. Local anesthesia before the procedure did not reduce the pain level in comparison with the placebo.

References

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U . The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003; 61(1):37-49. DOI: 10.1016/s0090-4295(02)02243-4. View

Haylen B, Ridder D, Freeman R, Swift S, Berghmans B, Lee J . An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2009; 21(1):5-26. DOI: 10.1007/s00192-009-0976-9. View

Milsom I, Abrams P, Cardozo L, Roberts R, Thuroff J, Wein A . How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001; 87(9):760-6. DOI: 10.1046/j.1464-410x.2001.02228.x. View

Stewart W, Van Rooyen J, Cundiff G, Abrams P, Herzog A, Corey R . Prevalence and burden of overactive bladder in the United States. World J Urol. 2003; 20(6):327-36. DOI: 10.1007/s00345-002-0301-4. View

Patrick D, Khalaf K, Dmochowski R, Kowalski J, Globe D . Psychometric performance of the incontinence quality-of-life questionnaire among patients with overactive bladder and urinary incontinence. Clin Ther. 2013; 35(6):836-45. DOI: 10.1016/j.clinthera.2013.04.013. View

Bartoli S, Aguzzi G, Tarricone R . Impact on quality of life of urinary incontinence and overactive bladder: a systematic literature review. Urology. 2009; 75(3):491-500. DOI: 10.1016/j.urology.2009.07.1325. View

Amarenco G, Arnould B, Carita P, Haab F, Labat J, Richard F . European psychometric validation of the CONTILIFE: a Quality of Life questionnaire for urinary incontinence. Eur Urol. 2003; 43(4):391-404. DOI: 10.1016/s0302-2838(03)00054-x. View

Cui Y, Wang L, Liu L, Zeng F, Niu J, Qi L . Botulinum toxin-A injections for idiopathic overactive bladder: a systematic review and meta-analysis. Urol Int. 2013; 91(4):429-38. DOI: 10.1159/000351037. View

Coelho A, Antunes-Lopes T, Gillespie J, Cruz F . Beta-3 adrenergic receptor is expressed in acetylcholine-containing nerve fibers of the human urinary bladder: An immunohistochemical study. Neurourol Urodyn. 2017; 36(8):1972-1980. DOI: 10.1002/nau.23224. View

10.

Michel M, Cardozo L, Chermansky C, Cruz F, Igawa Y, Lee K . Current and Emerging Pharmacological Targets and Treatments of Urinary Incontinence and Related Disorders. Pharmacol Rev. 2023; 75(4):554-674. DOI: 10.1124/pharmrev.121.000523. View

11.

Esquenazi A, Albanese A, Chancellor M, Elovic E, Segal K, Simpson D . Evidence-based review and assessment of botulinum neurotoxin for the treatment of adult spasticity in the upper motor neuron syndrome. Toxicon. 2012; 67:115-28. DOI: 10.1016/j.toxicon.2012.11.025. View

12.

Jost W, Benecke R, Hauschke D, Jankovic J, Kanovsky P, Roggenkamper P . Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders. Drug Des Devel Ther. 2015; 9:1913-26. PMC: 4389813. DOI: 10.2147/DDDT.S79193. View

13.

Giannantoni A, Gubbiotti M, Rubilotta E, Balzarro M, Antonelli A, Bini V . IncobotulinumtoxinA versus onabotulinumtoxinA intradetrusor injections in patients with neurogenic detrusor overactivity incontinence: a double-blind, randomized, non-inferiority trial. Minerva Urol Nephrol. 2021; 74(5):625-635. DOI: 10.23736/S2724-6051.21.04227-2. View

14.

Mangera A, Andersson K, Apostolidis A, Chapple C, Dasgupta P, Giannantoni A . Contemporary management of lower urinary tract disease with botulinum toxin A: a systematic review of botox (onabotulinumtoxinA) and dysport (abobotulinumtoxinA). Eur Urol. 2011; 60(4):784-95. DOI: 10.1016/j.eururo.2011.07.001. View

15.

Chapple C, Sievert K, MacDiarmid S, Khullar V, Radziszewski P, Nardo 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; 64(2):249-56. DOI: 10.1016/j.eururo.2013.04.001. View

16.

Skorupska K, Grzybowska M, Kubik-Komar A, Rechberger T, Miotla P . Identification of the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 cutoff scores in urinary incontinent women. Health Qual Life Outcomes. 2021; 19(1):87. PMC: 7962285. DOI: 10.1186/s12955-021-01721-z. View

17.

Shumaker S, Wyman J, Uebersax J, McClish D, Fantl J . Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res. 1994; 3(5):291-306. DOI: 10.1007/BF00451721. View

18.

Uebersax J, Wyman J, Shumaker S, McClish D, Fantl J . Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995; 14(2):131-9. DOI: 10.1002/nau.1930140206. View

19.

Patrick D, Martin M, Bushnell D, Yalcin I, Wagner T, Buesching D . Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology. 1999; 53(1):71-6. DOI: 10.1016/s0090-4295(98)00454-3. View

20.

Skorupska K, Miotla P, Kubik-Komar A, Skorupski P, Rechberger T . Development and validation of the Polish version of the Urogenital Distress Inventory short form and the Incontinence Impact Questionnaire short form. Eur J Obstet Gynecol Reprod Biol. 2017; 215:171-174. DOI: 10.1016/j.ejogrb.2017.06.024. View