Dysfunctional Voiding Clinical Trial
Official title:
Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding - A Multicenter Study, Randomized, Double-Blind, Placebo Control
Verified date | March 2017 |
Source | Buddhist Tzu Chi General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Adults with age of 20 years old or above. - Free of active urinary tract infection. - Free of bladder outlet obstruction on enrollment. - Patients should have severe dysuria or urinary retention, large residual urine and have been treated with medication or other therapeutic modality for over 3 months. Exclusion Criteria: - Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up. - Patients with bladder outlet obstruction on enrollment. - Patients with uncontrolled confirmed diagnosis of acute urinary tract infection. - Patients have laboratory abnormalities at screening including: Alanine aminotransferase (ALT) > 3 x upper limit of normal range aspartate aminotransferase (AST) > 3 x upper limit of normal range. - Patients have abnormal serum creatinine level > 2 x upper limit of normal range. - Patients with any contraindication to be urethral catheterization during treatment. - Female patients who is pregnant, lactating, or with child-bearing potential without contraception. - Patients with any other serious disease considered by the investigator not suitable for general anesthesia or in the condition to enter the trial. - Patients participated investigational drug trial within 1 month before entering this study. - Written informed consent has been obtained. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Buddhist Tzu Chi General Hospital | Hualien |
Lead Sponsor | Collaborator |
---|---|
Buddhist Tzu Chi General Hospital |
Taiwan,
Blaivas JG. Pathophysiology of lower urinary tract dysfunction. Urol Clin North Am. 1985 May;12(2):215-24. — View Citation
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. — View Citation
Carlson KV, Rome S, Nitti VW. Dysfunctional voiding in women. J Urol. 2001 Jan;165(1):143-7; discussion 147-8. — View Citation
Carson CC, Segura JW, Osborne DM. Evaluation and treatment of the female urethral syndrome. J Urol. 1980 Nov;124(5):609-10. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Fantl JA. Behavioral intervention for community-dwelling individuals with urinary incontinence. Urology. 1998 Feb;51(2A Suppl):30-4. Review. — View Citation
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. — View Citation
Grazko MA, Polo KB, Jabbari B. Botulinum toxin A for spasticity, muscle spasms, and rigidity. Neurology. 1995 Apr;45(4):712-7. — View Citation
Hinman F Jr. Nonneurogenic neurogenic bladder (the Hinman syndrome)--15 years later. J Urol. 1986 Oct;136(4):769-77. — View Citation
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. — View Citation
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. — View Citation
Kaplan WE, Firlit CF, Schoenberg HW. The female urethral syndrome: external sphincter spasm as etiology. J Urol. 1980 Jul;124(1):48-9. — View Citation
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.
Kuo HC. Videourodynamic evaluation of the pathophysiology of lower urinary tract symptoms in neurologically intact women. Tzu Chi Med J 11:203-213,1999.
Kvirkvelia L. Neocortical theta activity during learning in cats [proceedings]. Act Nerv Super (Praha). 1977 Mar;19(1):40-1. — View Citation
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. — View Citation
McGuire EJ, Savastano JA. Urodynamic studies in enuresis and the nonneurogenic neurogenic bladder. J Urol. 1984 Aug;132(2):299-302. — View Citation
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.
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. — View Citation
Raz S, Smith RB. External sphincter spasticity syndrome in female patients. J Urol. 1976 Apr;115(4):443-6. — View Citation
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. — View Citation
Schurch B, Stöhrer 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. — View Citation
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. — View Citation
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. — View Citation
Wennergren H, Oberg B. Pelvic floor exercises for children: a method of treating dysfunctional voiding. Br J Urol. 1995 Jul;76(1):9-15. Erratum in: Br J Urol 1995 Dec;76(6):815. — View Citation
* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Net change of Patient Perception of Bladder Condition (PPBC) | Efficacy: Efficacy measured the net change of Patient Perception of Bladder Condition (PPBC) at baseline and 4 weeks after the initial injection. If patients have a PPBC improved by two scales, they are considered as successfully treated, otherwise failed treatment. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the quality of life score | Efficacy: Efficacy measured the net change of the quality of life score at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Quality of life score which are adopted from the International Prostate Symptom Score (IPSS) system. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the maximal urethral closure pressure (MUCP) | Efficacy: Efficacy measured the net change of the maximal urethral closure pressure (MUCP) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the functional profile length (FPL) | Efficacy: Efficacy measured the net change of the functional profile length (FPL) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the cystometric bladder capacity (CBC) | Efficacy: Efficacy measured the net change of cystometric bladder capacity (CBC) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the bladder compliance | Efficacy: Efficacy measured the net change of the bladder compliance at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the voiding detrusor pressure (Pdet) | Efficacy: Efficacy measured the net change of the voiding detrusor pressure (Pdet) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the maximal flow rate (Qmax) | Efficacy: Efficacy measured the net change of the maximal flow rate (Qmax) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the voided volume | Efficacy: Efficacy measured the net change of the voided volume at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Safety: Systemic adverse events |
Baseline and 4 weeks | |
Secondary | Net change of the postvoid residual urine volume (PVR) | Efficacy: Efficacy measured the net change of the residual urine volume (PVR) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Safety: Systemic adverse events |
Baseline and 4 weeks |
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