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A multicentre, prospective, randomised, double-blind study to measure the treatment effectiveness of abobotulinum A (AboBTXA) among women with refractory interstitial cystitis/bladder pain syndrome

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Abstract

Introduction and hypothesis

To determine if abobotulinumtoxin A (AboBTXA) is an effective treatment for interstitial cystitis/bladder pain syndrome (IC/BPS).

Methods

We performed a double-blind study of 54 women with severe, refractory IC from three referral centres whom we randomly allocated to treatment with hydrodistension + injection of normal saline or to hydrodistension + injection with AboBTXA. The O’Leary-Sant questionnaire consists of problem (OLS-PI) and symptom (OLS-PI) index scores, and bladder diary data were compared between AboBTXA and control patients at baseline and at 3 months of follow-up. Measurements were made beyond 3 months, but no further randomised comparison was possible due to the ability of nonresponsive patients in either group to have AboBTXA treatment.

Results

Complete data were available in 50 patients, and in both groups, OLS questionnaires showed improvement at 3 months. Only the OLS-PI was improved in the AboBTXA group (p = 0.04). At 3 months, no difference was found in either OLS-SI or total OLS score. Twelve patients had urinary tract infection (UTI) treated during the follow-up period, which confounded results. In the 38 patients without UTI, there was improvement in total OLS score (p = 0.02), OLS-PI (0.08), and OLS-SI (p = 0.008) for the AboBTXA group at 3 months. Only five AboBTXA compared with two control patients had a 50 % reduction in OLS score.

Conclusions

For chronic refractory IC/BPS patients, AboBTXA was associated with no overall improvement in total OLS score, although significant benefit was noted in a small number of patients. The absence of posttreatment UTI was associated with a better response to AboBTXA.

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Abbreviations

OnaBTXA:

Onabotulinum A toxin (Botox®)

AboBTXA:

Abobotulinum A toxin (Dysport®)

UTI:

Urinary tract infection

IC/BPS:

Interstitial cystitis bladder pain syndrome

OLS:

O’Leary-Sant questionnaire score

BCG:

Bacille Calmette-Guerin

References

  1. Smith C, Radziszewski P, Borkowski A, Somogyi G, Boone T, Chancellor MB (2004) Botulinum toxin a has antinocicpetive effects in treating interstitial cystitis. Urology 64(5):871–875

    Article  PubMed  Google Scholar 

  2. Giannantoni A, Porena M, Costantini E, Zucchi A, Mearini L, Mearini E (2008) BotulinumA toxin intravesical injection in patients with painful bladder syndrome: 1-year followup. J Urol 179(3):1031–1034

    CAS  PubMed  Google Scholar 

  3. Ramsay AK, Small DR, Conn IG (2007) IntravesicalBotulinum toxin type A in chronic interstitial cystitis: results of a pilot study. Surg J R Coll Surg Edinb Ireland 5(6):331–333

    CAS  Google Scholar 

  4. Chuang YC, Yoshimura N, Huang CC, Chiang PH, Chancellor MB (2004) Intravesical Botulinum Toxin A administration produces analgesia against acetic acid induced bladder pain responses in rats. J Urol 172(4):1529–1532

    CAS  PubMed  Google Scholar 

  5. Pinto R, Silva A, Lopes T, Silva JF, Silva CM, Cruz FR, Dinis PO (2009) Intra-trigonal injection of Botulinum toxin A in patients with bladder pain syndrome.Results at 9 months of follow-up. J Urol 181(4,supplement):20

    Google Scholar 

  6. El-Bahnasy AE, Faharat YA, El-Bendary M, Taha MR, El-Damhogy M, Mourad S (2005) A randomised controlled trial of Bacillus Calmette-Guerin and Botulinum Toxin A for the treatment of refractory interstitial cystitis. UIJ 12(6):1944

    Google Scholar 

  7. Gillenwater JY, Wein AJ (1987) Summary of the National Institiute of Arthritis, Diabetes, Digestive and Kidney Diseases Workshop on Interstitial cystitis, National Institiutes of Health, Bethesda, Maryland, August 28-29. J Urol 1987(140):203–206

    Google Scholar 

  8. Karsai S, Raulin C (2010) Botox and Dysport: Is there a dose conversion ratio in dermatology and aesthetic medicine? J Am Acad Dermatol 62(2):346–347

    Article  PubMed  Google Scholar 

  9. Manstein C, Beidas OE (2011) Comparing Clinical Efficacy of Botox and Dysport in a Small Group of Patients. Plastic Reconstr Surg 128(1):26e

    Article  CAS  Google Scholar 

  10. Jacobson NS, Truax P (1991) Clincial Significance: A Statistical Approach to Defining Meaningful Change in Psychotherapy Research, J. Consult Clin Psychol 59(1):12–19

    Article  CAS  Google Scholar 

  11. Deyo RA, Diehr P, Patrick DL (1991) Reproducibility and Responsiveness of Health Status Measures. Control Clin Trials 12:142S–158S

    Article  CAS  PubMed  Google Scholar 

  12. Van de Merwe JNJ, Bouchelouche P, Bouchelouche K, Cervigni M, Daha L, Elneil S, Fall M, Hohlbrugger G, Irwin P, Mortensen S, van Ophoven A, Osborne J, Peeker R, Richter B, Riedl C, Sairanen J, Tinzl M, Wyndaele J-J (2008) Diagnostic Criteria, Classification, and Nomenclature for Painful Bladder Syndrome/Interstitial Cystitis: An ESSIC Proposal. Eur Urol 53:60–67

    Article  PubMed  Google Scholar 

  13. Kuo HC (2010) questionnaire) Preliminary results of suburothelial injection of botulinum a toxin in the treatment of chronic interstitial cystitis. Urol Int 75:170–174

    Article  Google Scholar 

  14. Lee CL, Kuo HC (2013) Intravesical botulinum toxin a injections do not benefit patients with ulcer type interstitial cystitis. Pain Phys 16(2):109–116

    Google Scholar 

  15. Davies A, Chahal R, Inman R, Urwin G (2006) Intravesicalbotulinum A toxin (Botox)-- does it have a role in the management of interstitial cystitis. Eur Urol, Suppl 5(suppl 2):22

    Google Scholar 

  16. Sairanen J, Leppilahti M, Tammela TL, Paananen I, Aaltomaa S, Taari K, Ruutu M (2009) Evaluation of health-related quality of life in patients with painful bladder syndrome/interstitial cystitis and the impact of four treatments on it. Scand J Urol Nephrol 43(3):212–219

    Article  CAS  PubMed  Google Scholar 

  17. Flynn MK, Amundsen CL, Perevich MA, Liu F, Webster GD (2009) Outcome of a randomized, double blind, placebo controlled trial of Botulinum A toxin for refractory overactive bladder. J Urol 181(6):2608–2615

    CAS  PubMed Central  PubMed  Google Scholar 

  18. Liu HT, Tyagi P, Chancellor MB, Kuo HC (2009) Urinary nerve growth factor level is increased in patients with interstitial cystitis/ bladder pain syndrome and decreased in responders to treatment. BJU Int 104(10):1476–1481

    Article  CAS  PubMed  Google Scholar 

  19. Jeffrey S, Fynes M, Lee F, Williams L, Morley R (2007) Efficacy and complications of intradetrusor injection with botulinum toxin A in patients with refractory idiopathic detrusor overactivity. BJU Int 100(6):1302–1306

    Article  Google Scholar 

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Conflict of Interest

PD is on Advisory Board for Allergan

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Authors and Affiliations

  1. John Hunter Hospital, PO Box 648, The Junction, 2291, NSW, Australia

    Jane Manning

  2. Mercy Hospital for Women, Vic, Australia

    Peter Dwyer & Christine Murray

  3. Monash Medical Centre, Vic, Australia

    Anna Rosamilia & Elizabeth Fitzgerald

  4. University of Newcastle, Newcastle, NSW, Australia

    Kim Colyvas

Authors
  1. Jane Manning
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  2. Peter Dwyer
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  3. Anna Rosamilia
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  4. Kim Colyvas
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  5. Christine Murray
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Correspondence to Jane Manning.

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Manning, J., Dwyer, P., Rosamilia, A. et al. A multicentre, prospective, randomised, double-blind study to measure the treatment effectiveness of abobotulinum A (AboBTXA) among women with refractory interstitial cystitis/bladder pain syndrome. Int Urogynecol J 25, 593–599 (2014). https://doi.org/10.1007/s00192-013-2267-8

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  • DOI: https://doi.org/10.1007/s00192-013-2267-8

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