Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxina in a randomized, placebo-controlled dose-finding study in idiopathic overactive bladder

Neurourology and Urodynamics

Volumn 30, Issue 4, 2011, Pages 556-562

  Rovner, Eric ^a   Kennelly, Michael ^b   Schulte Baukloh, Heinrich ^c   Zhou, Jihao ^d,e   Haag Molkenteller, Cornelia ^d   Dasgupta, Prokar ^f  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b Carolinas Rehabilitation   (United States)

^c HUMBOLDT UNIVERSITY   (Germany)

^d ALLERGAN INC   (United States)

^e INDIANA UNIVERSITY   (United States)

^f KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

botulinum toxin type A; detrusor overactivity; dose response relationship; drug; overactive; urgency; urinary bladder; urinary incontinence; urinary retention

Indexed keywords

BOTULINUM TOXIN A; CHOLINERGIC RECEPTOR BLOCKING AGENT; PLACEBO;

ADULT; AGED; ARTICLE; BLADDER CAPACITY; BLADDER COMPLIANCE; BLADDER CONTRACTION; CONTROLLED STUDY; CYSTOMETRY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OVERACTIVE BLADDER; PARALYSIS; POSTVOID RESIDUAL URINE VOLUME; RANDOMIZED CONTROLLED TRIAL; RESPIRATION DEPRESSION; SINGLE DRUG DOSE; URGE INCONTINENCE; URINARY TRACT INFECTION; URINE RETENTION; URODYNAMICS; XEROSTOMIA;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BOTULINUM TOXINS, TYPE A; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INJECTIONS, INTRAMUSCULAR; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; PATIENT SELECTION; TREATMENT OUTCOME; URINARY BLADDER, OVERACTIVE; URINARY INCONTINENCE; URODYNAMICS;

EID: 79954603137     PISSN: 07332467     EISSN: 15206777     Source Type: Journal    
DOI: 10.1002/nau.21021     Document Type: Article

References (25)

1. Abrams P, Artibani W, Cardozo L, et al. Reviewing the ICS 2002 terminology report: the ongoing debate. Neurourol Urodyn 2009; 28: 287.
2. Homma Y, Batista J, S B, et al. Urodynamics. In:, Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence, 2nd edition. Jersey, UK: Health Publication Ltd; 2002. p. 317-72.
3. Hashim H, Abrams P,. Is the bladder a reliable witness for predicting detrusor overactivity? J Urol 2006; 175: 191-4, discussion 194-5. (Pubitemid 41797136)
4. Andersson KE,. Antimuscarinics for treatment of overactive bladder. Lancet Neurol 2004; 3: 46-53.
5. Flynn MK, Webster GD, Amundsen CL,. The effect of botulinum-A toxin on patients with severe urge urinary incontinence. J Urol 2004; 172: 2316-20. (Pubitemid 39507517)
6. Kessler TM, Danuser H, Schumacher M, et al. Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity? Neurourol Urodyn 2005; 24: 231-6. (Pubitemid 40617096)
7. Kuo HC,. Clinical effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity refractory to anticholinergics. Urology 2005; 66: 94-8.
8. Popat R, Apostolidis A, Kalsi V, et al. A comparison between the response of patients with idiopathic detrusor overactivity and neurogenic detrusor overactivity to the first intradetrusor injection of botulinum-A toxin. J Urol 2005; 174: 984-9. (Pubitemid 41140656)
9. Rajkumar GN, Small DR, Mustafa AW, et al. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int 2005; 96: 848-52. (Pubitemid 41391395)
10. Schmid DM, Sauermann P, Werner M, et al. Experience with 100 cases treated with botulinum-A toxin injections in the detrusor muscle for idiopathic overactive bladder syndrome refractory to anticholinergics. J Urol 2006; 176: 177-85. (Pubitemid 43815416)
11. Schulte-Baukloh H, Weiss C, Stolze T, et al. Botulinum-A toxin detrusor and sphincter injection in treatment of overactive bladder syndrome: objective outcome and patient satisfaction. Eur Urol 2005; 48: 984-90, discussion 990. (Pubitemid 41641650)
12. Flynn MK, Amundsen CL, Perevich M, et al. Outcome of a randomized, double-blind, placebo controlled trial of botulinum A toxin for refractory overactive bladder. J Urol 2009; 181: 2608-15.
13. 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: 2231-6. (Pubitemid 46726400)
14. Apostolidis A, Popat R, Yiangou Y, et al. Decreased sensory receptors P2X3 and TRPV1 in suburothelial nerve fibers following intradetrusor injections of botulinum toxin for human detrusor overactivity. J Urol 2005; 174: 977-82, discussion 982-973. (Pubitemid 41140654)
15. Dmochowski R, Chapple C, Nitti VW, et al. Efficacy and safety of onabotulinumtoxinA in idiopathic overactive bladder: a double-blind, placebo-controlled, randomized, dose-ranging trial. J Urol 2010; 184: 2416-2422.
16. Fowler C, Auerbach S, Ginsberg D, et al. Botulinum toxin A (BOTOX) demonstrates dose-dependent improvements in health-related quality-of-life measures in idiopathic overactive bladder. American Urological Association 2009 Annual Meeting. Chicago, IL, 2009.
17. Malone-Lee JG, Al-Buheissi S,. Does urodynamic verification of overactive bladder determine treatment success? Results from a randomized placebo-controlled study. BJU Int 2009; 103: 931-7.
18. Nitti VW, Rovner ES, Bavendam T,. Response to fesoterodine in patients with an overactive bladder and urgency urinary incontinence is independent of the urodynamic finding of detrusor overactivity. BJU Int 2010; 105: 1268-75.
19. DuBeau CE, Khullar V, Versi E,. " Unblinding" in randomized controlled drug trials for urinary incontinence: implications for assessing outcomes when adverse effects are evident. Neurourol Urodyn 2005; 24: 13-20. (Pubitemid 40052533)
20. Lemack GE,. Urodynamic assessment of overactive bladder: neurogenic and nonneurogenic. In:, Goldman HB, Vasavada SP, editors. Female urology: a practical clinical guide. Totowa, NJ: Humana Press Inc; 2008. p. 51-60.
21. Sahai A, Khan MS, Le Gall N, et al. Urodynamic assessment of poor responders after botulinum toxin-A treatment for overactive bladder. Urology 2008; 71: 455-9. (Pubitemid 351374741)
22. Heslington K, Hilton P,. Ambulatory monitoring and conventional cystometry in asymptomatic female volunteers. Br J Obstet Gynaecol 1996; 103: 434-41. (Pubitemid 26141633)
23. Hosker G, Rosier P, Gajewski J, et al. Dynamic testing. In:, Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence, 4th edition. Jersey, UK: Health Publication Ltd; 2009; p. 413-522.
24. van Waalwijk van Doorn ES, Meier AH, Ambergen AW, et al. Ambulatory urodynamics: extramural testing of the lower and upper urinary tract by Holter monitoring of cystometrogram, uroflowmetry, and renal pelvic pressures. Urol Clin North Am 1996; 23: 345-71. (Pubitemid 26260181)
25. Wyndaele JJ,. Normality in urodynamics studied in healthy adults. J Urol 1999; 161: 899-902.