drugset / Trial / NCT01733290
Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients with dysfunctional voiding. The results of this study can provide further information for patient selection and therapeutic duration.
Timeline
- Start
- 2012-10
- Primary completion
- 2017-02
- Completion
- 2017-02
Publications
- Background Blaivas JG. Pathophysiology of lower urinary tract dysfunction. Urol Clin North Am. 1985 May;12(2):215-24.
- Background Elbadawi A, Schenk EA. A new theory of the innervation of bladder musculature. 4. Innervation of the vesicourethral junction and external urethral sphincter. J Urol. 1974 May;111(5):613-5. doi: 10.1016/s0022-5347(17)60028-4. No abstract available.
- Background Kuo HC. Effectiveness of baclofen plus terazosin treatment in patients with lower urinary tract symptoms caused by spastic urethral sphincter. Tzu Chi Med J 12:141-148, 2000.
- Background Kaplan SA, Ikeguchi EF, Santarosa RP, D'Alisera PM, Hendricks J, Te AE, Miller MI. Etiology of voiding dysfunction in men less than 50 years of age. Urology. 1996 Jun;47(6):836-9. doi: 10.1016/S0090-4295(96)00038-6.
- Background Kvirkvelia L. Neocortical theta activity during learning in cats [proceedings]. Act Nerv Super (Praha). 1977 Mar;19(1):40-1. No abstract available.
- Background Carson CC, Segura JW, Osborne DM. Evaluation and treatment of the female urethral syndrome. J Urol. 1980 Nov;124(5):609-10. doi: 10.1016/s0022-5347(17)55578-0.
- Background Raz S, Smith RB. External sphincter spasticity syndrome in female patients. J Urol. 1976 Apr;115(4):443-6. doi: 10.1016/s0022-5347(17)59235-6.
- Background Deindl FM, Vodusek DB, Bischoff C, Hofmann R, Hartung R. Dysfunctional voiding in women: which muscles are responsible? Br J Urol. 1998 Dec;82(6):814-9. doi: 10.1046/j.1464-410x.1998.00866.x.
- Background Nitti VW, Fiske J. Cystometrogram versus cystometrogram plus voiding pressure-flow studies in women with lower urinary tract symptoms. J Urol 161(Suppl):201,1999.
- Background Kuo HC. Videourodynamic evaluation of the pathophysiology of lower urinary tract symptoms in neurologically intact women. Tzu Chi Med J 11:203-213,1999.
- Background Hinman F Jr. Nonneurogenic neurogenic bladder (the Hinman syndrome)--15 years later. J Urol. 1986 Oct;136(4):769-77. doi: 10.1016/s0022-5347(17)45077-4.
- Background Kaplan WE, Firlit CF, Schoenberg HW. The female urethral syndrome: external sphincter spasm as etiology. J Urol. 1980 Jul;124(1):48-9. doi: 10.1016/s0022-5347(17)55287-8.
- Background McGuire EJ, Savastano JA. Urodynamic studies in enuresis and the nonneurogenic neurogenic bladder. J Urol. 1984 Aug;132(2):299-302. doi: 10.1016/s0022-5347(17)49603-0.
- Background Fantl JA. Behavioral intervention for community-dwelling individuals with urinary incontinence. Urology. 1998 Feb;51(2A Suppl):30-4. doi: 10.1016/s0090-4295(98)90006-1.
- Background Carlson KV, Rome S, Nitti VW. Dysfunctional voiding in women. J Urol. 2001 Jan;165(1):143-7; discussion 147-8. doi: 10.1097/00005392-200101000-00035.
- Background De Paepe H, Hoebeke P, Renson C, Van Laecke E, Raes A, Van Hoecke E, Van Daele J, Vande Walle J. Pelvic-floor therapy in girls with recurrent urinary tract infections and dysfunctional voiding. Br J Urol. 1998 May;81 Suppl 3:109-13. doi: 10.1046/j.1464-410x.1998.00021.x.
- Background Wennergren H, Oberg B. Pelvic floor exercises for children: a method of treating dysfunctional voiding. Br J Urol. 1995 Jul;76(1):9-15. doi: 10.1111/j.1464-410x.1995.tb07823.x.
- Background Vijverberg MA, Elzinga-Plomp A, Messer AP, van Gool JD, de Jong TP. Bladder rehabilitation, the effect of a cognitive training programme on urge incontinence. Eur Urol. 1997;31(1):68-72. doi: 10.1159/000474421.
- Background Grazko MA, Polo KB, Jabbari B. Botulinum toxin A for spasticity, muscle spasms, and rigidity. Neurology. 1995 Apr;45(4):712-7. doi: 10.1212/wnl.45.4.712.
- Background Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.
- Background Dykstra DD, Sidi AA. Treatment of detrusor-sphincter dyssynergia with botulinum A toxin: a double-blind study. Arch Phys Med Rehabil. 1990 Jan;71(1):24-6.
- Background Schurch B, Hauri D, Rodic B, Curt A, Meyer M, Rossier AB. Botulinum-A toxin as a treatment of detrusor-sphincter dyssynergia: a prospective study in 24 spinal cord injury patients. J Urol. 1996 Mar;155(3):1023-9. doi: 10.1016/s0022-5347(01)66376-6.
- Background Gallien P, Robineau S, Verin M, Le Bot MP, Nicolas B, Brissot R. Treatment of detrusor sphincter dyssynergia by transperineal injection of botulinum toxin. Arch Phys Med Rehabil. 1998 Jun;79(6):715-7. doi: 10.1016/s0003-9993(98)90050-8.
- Background Borodic GE, Joseph M, Fay L, Cozzolino D, Ferrante RJ. Botulinum A toxin for the treatment of spasmodic torticollis: dysphagia and regional toxin spread. Head Neck. 1990 Sep-Oct;12(5):392-9. doi: 10.1002/hed.2880120504.
- Background Phelan MW, Franks M, Somogyi GT, Yokoyama T, Fraser MO, Lavelle JP, Yoshimura N, Chancellor MB. Botulinum toxin urethral sphincter injection to restore bladder emptying in men and women with voiding dysfunction. J Urol. 2001 Apr;165(4):1107-10.
- Background Schurch B, Stohrer M, Kramer G, Schmid DM, Gaul G, Hauri D. Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs? Preliminary results. J Urol. 2000 Sep;164(3 Pt 1):692-7. doi: 10.1097/00005392-200009010-00018.
- Background Steinhardt GF, Naseer S, Cruz OA. Botulinum toxin: novel treatment for dramatic urethral dilatation associated with dysfunctional voiding. J Urol. 1997 Jul;158(1):190-1. doi: 10.1097/00005392-199707000-00067. No abstract available.
- Background Maria G, Destito A, Lacquaniti S, Bentivoglio AR, Brisinda G, Albanese A. Relief by botulinum toxin of voiding dysfunction due to prostatitis. Lancet. 1998 Aug 22;352(9128):625. doi: 10.1016/S0140-6736(05)79580-5. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 100 iu | Other |