Araştırma Makalesi
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Antikolinerjik Tedaviye Dirençli İdiopatik Aşırı Aktif Mesane Hastalarında 200 IU OnabotulinumtoxinA (Botulinum Toksin Tip A) Etkinliği: Retrospektif Analiz

Yıl 2025, Cilt: 20 Sayı: 2, 64 - 70, 29.06.2025
https://doi.org/10.33719/nju1550632

Öz

Amaç: Bu çalışmanın amacı, antikolinerjik tedaviye yanıt vermeyen idiyopatik aşırı aktif mesane (AAM) ve idrar kaçırma sorunu olan hastalarda 200 IU onabotulinumtoxinA'nın etkinliğini ve güvenliğini değerlendirmektir. Ayrıca, mesane duvarı kalınlığındaki (MDK) azalma ile tedavi sonuçları arasındaki ilişkiyi incelemek de hedeflenmiştir.

Yöntemler: Ocak 2016 ile Haziran 2022 arasında tedavi edilen hastalar üzerinde retrospektif bir analiz yapılmıştır. Başlangıç semptomları ve yaşam kalitesi verileri, tedavi sonrası altı ayda elde edilen verilerle karşılaştırılmıştır. Başlangıçta yapılan ultrason (US) ölçümleri ile postvoid rezidüel idrar (PVR) ve MDK kayıt altına alınmıştır. Nörolojik hastalık öyküsü bulunan, antikolinerjik tedavi almamış, mesane kanseri tanısı almış veya mesane çıkış obstrüksiyonu olan hastalar dışlanmıştır.

Bulgular: Çalışmaya 36.05 yaş ortalamasına sahip 60 hasta (41 kadın, 19 erkek) dahil edilmiştir. Altı ay sonunda AAM semptomlarında, ortalama idrara çıkma sıklığı, nokturna ve idrar kaçırma olaylarında istatistiksel olarak anlamlı iyileşmeler gözlenmiştir (p<0.001). Ayrıca, MDK'da kayda değer azalmalar görülmüştür (medyan ve ortalama değerler sırasıyla 5.25 mm ve 5.22 mm'den 4.60 mm ve 4.66 mm'ye düşmüştür). İki hasta idrar yolu enfeksiyonu yaşamış, hiçbiri temiz aralıklı kateterizasyon (TAK) gerektirmemiştir.

Sonuçlar: OnabotulinumtoxinA, antikolinerjik tedaviye yanıt vermeyen hastalarda semptomlar ve hasta tarafından bildirilen sonuçlarda belirgin iyileşmeler göstermiştir. MDK'daki azalma, tedavi başarısını değerlendirmek için değerli bir parametre olabilir, ancak istatistiksel analiz içeren daha fazla araştırmaya ihtiyaç vardır.

Kaynakça

  • 1. Haylen BT, De Ridder D, Freeman RM, et al. 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. https://doi.org/10.1007/s00192-009-0976-9
  • 2. Hsieh PF, Chiu HC, Chen KC, et al. Botulinum toxin A for the Treatment of Overactive Bladder. Toxin (Basel). 2016 Feb 29;8(3):59. https://doi.org/10.3390/toxins8030059
  • 3. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-36. https://doi.org/10.1007/s00345-002-0301-4
  • 4. Chapple C, Sievert KD, Macdiarmid S, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence in a randomized, double-blind, placebo-controlled trial. Eur Urol. 2013;64(2):249-56. https://doi.org/10.1016/j.eururo.2013.04.001
  • 5. Tincello DG. Botulinum toxin treatment of overactive bladder and detrusor overactivity in adults. World J Urol. 2012;30(4):451-6. https://doi.org/10.1007/s00345-011-0778-9
  • 6. Herbison P, Hay-Smith J, Ellis G, et al. Effectiveness of anticholinergic drugs compared with placebo in the treatment of overactive bladder: systematic review. BMJ. 2003 Apr 19;326(7394):841-4. https://doi.org/10.1136/bmj.326.7394.841
  • 7. Kelleher CJ, Cardozo LD, Khullar V et al. Medium-term analysis of subjective efficacy of treatment in women with detrusor instability and low bladder compliance. Br J Obstet Gynaecol. 1997;104(9):988-93. https://doi.org/10.1111/j.1471-0528.1997.tb12054.x
  • 8. Lucas MG, Bosch RJL, Burkhard FC, et al. EAU guidelines for the surgical treatment of urinary incontinence. European Association of Urology [Internet]. EAU guidelines on surgical treatment of urinary incontinence. Eur Urol. 2012;62(6):1118-29. https://doi.org/10.1016/j.eururo.2012.09.023
  • 9. Lightner DJ, Gomelsky A, Souter L, et al. Diagnosis and Treatment of Overactive Bladder (non-neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019;202(3):558-563. https://doi.org/10.1097/JU.0000000000000309
  • 10. Duthie JB, Vincent M, Herbison GP, et al. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev. 2011;(12). https://doi.org/10.1002/14651858.CD005493.pub3
  • 11. Sahai A, Khan MS, Dasgupta P. Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single-center, randomized, double-blind, placebo-controlled trial. J Urol. 2007;177(6):2231-6. https://doi.org/10.1016/j.juro.2007.01.130
  • 12. Brubaker L, Richter HE, Visco A, et al. Pelvic floor disorder network. Refractory idiopathic urge urinary incontinence and botulinum A injections. J Urol. 2008;180(1):217-22. https://doi.org/10.1016/j.juro.2008.03.028
  • 13. Rovner E, Kennelly M, Schulte-Baukloh H, et al. Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxinA in a randomized, placebo-controlled dose-finding study in idiopathic overactive bladder. Neurourol Urodyn. 2011;30(4):556-62. https://doi.org/10.1002/nau.21021
  • 14. Dmochowski R, Chapple C, Nitti VW, et al. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo-controlled, randomized, dose-ranging trial. J Urol. 2010;184(6):2416-22. https://doi.org/10.1016/j.juro.2010.08.021
  • 15. Tincello DG, Kenyon S, Abrams KR, et al. Botulinum toxin a versus placebo for refractory detrusor overactivity in women: A randomized blinded placebo-controlled trial of 240 women (the RELAX study). Eur Urol. 2012;62(3):507-14. https://doi.org/10.1016/j.eururo.2011.12.056
  • 16. Robinson D, Anders K, Cardozo L, et al. Can ultrasound replace ambulatory urodynamics in women with irritative urinary symptoms? BJOG. 2002;109(2):145-8. https://doi.org/10.1111/j.1471-0528.2002.01021.x
  • 17. Robinson D, Oelke M, Khullar V, et al. Bladder wall thickness in women with symptoms of overactive bladder and detrusor overactivity: Results from a randomized, placebo-controlled shrink study. Neurourol Urodyn. 2016;35(7):819-25. https://doi.org/10.1002/nau.22808
  • 18. Compérat E, Reitz A, Delcourt A, et al. Histologic features in the urinary bladder wall affected from neurogenic overactivity--a comparison of inflammation, oedema and fibrosis with and without injection of botulinum toxin type A. Eur Urol. 2006;50(5):1058-64. https://doi.org/10.1016/j.eururo.2006.01.025
  • 19. Bartoli, S, Aguzzi, G, Tarricone, R. Impact of urinary incontinence and overactive bladder on quality of life: A systematic literature review. Urology. 2010;75(3):491-500. https://doi.org/10.1016/j.urology.2009.07.1325
  • 20. Höfner K, Burkart M, Jacob G, et al. Symptomatic and quality of life response to tolterodine in subgroups of men with overactive bladder symptoms and presumed non-obstructive benign prostatic hyperplasia. World J Urol. 2010;28(3):353-7. https://doi.org/10.1007/s00345-009-0460-7
  • 21. Denys P, Le Normand L, Ghout I, et al. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: A multicenter, double-blind, randomized, placebo-controlled dose-ranging study. Eur Urol. 2012;61(3):520-9. https://doi.org/10.1016/j.eururo.2011.10.028
  • 22. Flynn MK, Amundsen CL, Perevich M, et al. Outcomes of a randomized, double-blind, placebo-controlled trial of botulinum A toxin for refractory overactive bladder. J Urol. 2009;181(6):2608-15. https://doi.org/10.1016/j.juro.2009.01.117
  • 23. Smith CP, Chancellor MB. Simplified bladder botulinum toxin delivery technique using a flexible cystoscope and 10 injection sites. J Endourol. 2005;19(7):880-2. https://doi.org/10.1089/end.2005.19.880
  • 24. Latthe PM, Champaneria R, Khan KS, et al. A systematic review of the accuracy of ultrasound as a method of measuring bladder wall thickness in the diagnosis of detrusor overactivity. Int Urogynecol J. 2010;21(8):1019-24. https://doi.org/10.1007/s00192-010-1144-y

Efficacy of 200 IU OnabotulinumtoxinA (Botulinum Toxin Type A) in Patients with Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment: A Retrospective Analysis

Yıl 2025, Cilt: 20 Sayı: 2, 64 - 70, 29.06.2025
https://doi.org/10.33719/nju1550632

Öz

Objective: This study aimed to evaluate the efficacy and safety of 200 IU of onabotulinumtoxinA in patients with idiopathic overactive bladder (OAB) and urinary incontinence who had previously shown no response to anticholinergic treatment. This study also sought to examine the impact of a reduction in bladder wall thickness (BWT) on treatment outcomes.
Material and Methods: A retrospective analysis was conducted on patients treated between January 2016 and June 2022. Baseline symptoms and quality of life data were compared with those obtained six months post-treatment. Baseline ultrasound (US)-measured post-void residual urine (PVR) and BWT were recorded. Patients with a history of neurological disorders, anticholinergic-naive patients, those diagnosed with bladder cancer, and those with bladder outlet obstruction were excluded.
Results: This study included 60 patients (41 females and 19 males) with a mean age of 36.05 years. At six months, statistically significant improvements were observed in OAB symptoms, including average urination frequency, nocturia, and incontinence episodes (p<0.001). Noteworthy reductions in BWT were also observed (median and mean values decreased from 5.25 mm and 5.22 mm to 4.60 mm and 4.66 mm, respectively). Two patients experienced urinary tract infections, and none required clean intermittent catheterization (CIC).
Conclusions: OnabotulinumtoxinA demonstrated substantial improvements in symptoms and patient-reported outcomes in patients who previously failed to respond to anticholinergic treatment. BWT reduction may be a valuable parameter for evaluating treatment success, although further research with statistical analysis is necessary.

Etik Beyan

Ministry of Health Hisar Hospital Medical and Ethical Advisory Board Date: 10.11.2023 Protocol: 23/54. This study was conducted in accordance with the Declaration of Helsinki of the World Medical Association.

Destekleyen Kurum

None.

Kaynakça

  • 1. Haylen BT, De Ridder D, Freeman RM, et al. 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. https://doi.org/10.1007/s00192-009-0976-9
  • 2. Hsieh PF, Chiu HC, Chen KC, et al. Botulinum toxin A for the Treatment of Overactive Bladder. Toxin (Basel). 2016 Feb 29;8(3):59. https://doi.org/10.3390/toxins8030059
  • 3. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-36. https://doi.org/10.1007/s00345-002-0301-4
  • 4. Chapple C, Sievert KD, Macdiarmid S, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence in a randomized, double-blind, placebo-controlled trial. Eur Urol. 2013;64(2):249-56. https://doi.org/10.1016/j.eururo.2013.04.001
  • 5. Tincello DG. Botulinum toxin treatment of overactive bladder and detrusor overactivity in adults. World J Urol. 2012;30(4):451-6. https://doi.org/10.1007/s00345-011-0778-9
  • 6. Herbison P, Hay-Smith J, Ellis G, et al. Effectiveness of anticholinergic drugs compared with placebo in the treatment of overactive bladder: systematic review. BMJ. 2003 Apr 19;326(7394):841-4. https://doi.org/10.1136/bmj.326.7394.841
  • 7. Kelleher CJ, Cardozo LD, Khullar V et al. Medium-term analysis of subjective efficacy of treatment in women with detrusor instability and low bladder compliance. Br J Obstet Gynaecol. 1997;104(9):988-93. https://doi.org/10.1111/j.1471-0528.1997.tb12054.x
  • 8. Lucas MG, Bosch RJL, Burkhard FC, et al. EAU guidelines for the surgical treatment of urinary incontinence. European Association of Urology [Internet]. EAU guidelines on surgical treatment of urinary incontinence. Eur Urol. 2012;62(6):1118-29. https://doi.org/10.1016/j.eururo.2012.09.023
  • 9. Lightner DJ, Gomelsky A, Souter L, et al. Diagnosis and Treatment of Overactive Bladder (non-neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019;202(3):558-563. https://doi.org/10.1097/JU.0000000000000309
  • 10. Duthie JB, Vincent M, Herbison GP, et al. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev. 2011;(12). https://doi.org/10.1002/14651858.CD005493.pub3
  • 11. Sahai A, Khan MS, Dasgupta P. Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single-center, randomized, double-blind, placebo-controlled trial. J Urol. 2007;177(6):2231-6. https://doi.org/10.1016/j.juro.2007.01.130
  • 12. Brubaker L, Richter HE, Visco A, et al. Pelvic floor disorder network. Refractory idiopathic urge urinary incontinence and botulinum A injections. J Urol. 2008;180(1):217-22. https://doi.org/10.1016/j.juro.2008.03.028
  • 13. Rovner E, Kennelly M, Schulte-Baukloh H, et al. Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxinA in a randomized, placebo-controlled dose-finding study in idiopathic overactive bladder. Neurourol Urodyn. 2011;30(4):556-62. https://doi.org/10.1002/nau.21021
  • 14. Dmochowski R, Chapple C, Nitti VW, et al. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo-controlled, randomized, dose-ranging trial. J Urol. 2010;184(6):2416-22. https://doi.org/10.1016/j.juro.2010.08.021
  • 15. Tincello DG, Kenyon S, Abrams KR, et al. Botulinum toxin a versus placebo for refractory detrusor overactivity in women: A randomized blinded placebo-controlled trial of 240 women (the RELAX study). Eur Urol. 2012;62(3):507-14. https://doi.org/10.1016/j.eururo.2011.12.056
  • 16. Robinson D, Anders K, Cardozo L, et al. Can ultrasound replace ambulatory urodynamics in women with irritative urinary symptoms? BJOG. 2002;109(2):145-8. https://doi.org/10.1111/j.1471-0528.2002.01021.x
  • 17. Robinson D, Oelke M, Khullar V, et al. Bladder wall thickness in women with symptoms of overactive bladder and detrusor overactivity: Results from a randomized, placebo-controlled shrink study. Neurourol Urodyn. 2016;35(7):819-25. https://doi.org/10.1002/nau.22808
  • 18. Compérat E, Reitz A, Delcourt A, et al. Histologic features in the urinary bladder wall affected from neurogenic overactivity--a comparison of inflammation, oedema and fibrosis with and without injection of botulinum toxin type A. Eur Urol. 2006;50(5):1058-64. https://doi.org/10.1016/j.eururo.2006.01.025
  • 19. Bartoli, S, Aguzzi, G, Tarricone, R. Impact of urinary incontinence and overactive bladder on quality of life: A systematic literature review. Urology. 2010;75(3):491-500. https://doi.org/10.1016/j.urology.2009.07.1325
  • 20. Höfner K, Burkart M, Jacob G, et al. Symptomatic and quality of life response to tolterodine in subgroups of men with overactive bladder symptoms and presumed non-obstructive benign prostatic hyperplasia. World J Urol. 2010;28(3):353-7. https://doi.org/10.1007/s00345-009-0460-7
  • 21. Denys P, Le Normand L, Ghout I, et al. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: A multicenter, double-blind, randomized, placebo-controlled dose-ranging study. Eur Urol. 2012;61(3):520-9. https://doi.org/10.1016/j.eururo.2011.10.028
  • 22. Flynn MK, Amundsen CL, Perevich M, et al. Outcomes of a randomized, double-blind, placebo-controlled trial of botulinum A toxin for refractory overactive bladder. J Urol. 2009;181(6):2608-15. https://doi.org/10.1016/j.juro.2009.01.117
  • 23. Smith CP, Chancellor MB. Simplified bladder botulinum toxin delivery technique using a flexible cystoscope and 10 injection sites. J Endourol. 2005;19(7):880-2. https://doi.org/10.1089/end.2005.19.880
  • 24. Latthe PM, Champaneria R, Khan KS, et al. A systematic review of the accuracy of ultrasound as a method of measuring bladder wall thickness in the diagnosis of detrusor overactivity. Int Urogynecol J. 2010;21(8):1019-24. https://doi.org/10.1007/s00192-010-1144-y
Toplam 24 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Üroloji
Bölüm Araştırma Makalesi
Yazarlar

Ali Egemen Avci

Basri Cakiroglu 0000-0001-5337-5226

Mehmet Gürkan Arıkan

Meftun Çulpan 0000-0001-8573-1192

Yayımlanma Tarihi 29 Haziran 2025
Gönderilme Tarihi 16 Eylül 2024
Kabul Tarihi 3 Nisan 2025
Yayımlandığı Sayı Yıl 2025 Cilt: 20 Sayı: 2

Kaynak Göster

Vancouver Avci AE, Cakiroglu B, Arıkan MG, Çulpan M. Efficacy of 200 IU OnabotulinumtoxinA (Botulinum Toxin Type A) in Patients with Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment: A Retrospective Analysis. New J Urol. 2025;20(2):64-70.