- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657409
Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome
Comparison of the Therapeutic Effects of Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a single blind, randomized, parallel, actively controlled trial. The urodynamic DO confirmed patients were randomly assigned to receive injection of onabotulinumtoxinA 100 U (BoNT-A, Allergan, Irvine, California, USA), which was reconstituted to 10 ml with normal saline for suburothelial injections, in one of the three groups with the following injection number: (A) 100 U in 10ml injections, 1.0ml for each injection, totally 10 injections at bladder body (B) 100 U in 10ml, 0.5ml for each injection, totally 20 injections at bladder body, (C) 100 U in 10ml, 0.25ml for each injection, totally 40 injections at bladder body. Permuted block randomization was used for this trial. All treatments were evaluated at baseline and the primary end-point at 3 months.
The inclusion criteria were patients of either gender, aged 20 years or more, with urodynamic DO and at least one episode of urgency (urgency severity scale, USS≥2) or UUI per day as recorded in the 3-day voiding diary. Patients with neurogenic bladder, urodynamically confirmed bladder outlet obstruction, prior pelvic surgery, anti-incontinence surgery or urinary tract infection (UTI, white blood cell(WBC)>10/high power field (HPF) in urinalysis) were excluded. Informed consent was obtained from all patients before randomization. This study should be approved by the Institution Review Board and Ethics Committee of the hospital.
All patients had been managed with behavioral modification and treated with a certain number of antimuscarinics for more than 4 weeks before they were enrolled into this trial. Antimuscarinics was discontinued on the day of screening to wash out the remaining effect and obtaining a voiding diary that may reflect the true bladder condition.
The injection method for each patient was not recorded in the operation note and the study nurse who controlled the outcome measures was blinded to the treatment assignment. All procedures were performed transurethrally under intravenous general anesthesia in the operation room. Anticoagulant was discontinued 1 week prior to onabotulinumtoxinA treatment. The bladder volume was kept at 100-150 ml and the blood vessels were avoided during injections. An indwelling Foley catheter was placed in the bladder overnight and the patients were discharged the next morning. Broad-spectrum prophylactic antibiotics were given postoperatively for 3 days. Patients who developed acute urinary retention (AUR) or PVR volumes greater than 250 ml were advised to perform CIC periodically to evacuate their bladders. The patients were monitored at the outpatient clinic regularly for upto 24 months until symptoms returned to baseline levels.
Videourodynamic study was routinely performed at baseline, 3 and 6 months to measure urodynamic variables and detecting vesicoureteral reflux. The measured urodynamic variables included: maximum flow rate (Qmax), PVR, cystometric bladder capacity (CBC), detrusor pressure at Qmax (Pdet) and voiding efficiency (VE). The procedure and definition of videourodynamic study were in accordance of the recommendations of the International Continence Society.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Hualien, Taiwan, 970
- Buddhist Tzu Chi General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The inclusion criteria were patients of either gender, aged 20 years or more, with urodynamic DO and at least one episode of urgency (urgency severity scale, USS≥2) or UUI per day as recorded in the 3-day voiding diary. Patients with neurogenic bladder, urodynamically confirmed bladder outlet obstruction, prior pelvic surgery, anti-incontinence surgery or urinary tract infection (UTI, white blood cell (WBC) >10/high power field (HPF) in urinalysis) were excluded. Informed consent was obtained from all patients before randomization. This study should be approved by the Institution Review Board and Ethics Committee of the hospital.
Exclusion Criteria:
- Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms
- 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 postvoid residual > 150ml
- 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.
- Myasthenia gravis, Eaton Lambert syndrome.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BoNT-A (10 injection)
100 U in 10ml, 1.0ml for each injection, totally 10 injections at bladder body
|
BoNT-A 100 U 10 injections
Other Names:
|
Experimental: BoNT-A (20 injections)
100 U in 10ml, 0.5ml for each injection, totally 20 injections at bladder body
|
BoNT-A 100 U 20 injections
Other Names:
|
Experimental: BoNT-A (40 injections)
100 U in 10ml, 0.25ml for each injection, totally 40 injections at bladder body
|
BoNT-A 100 U 40 injections
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global response assessment (GRA) of satisfaction by the patient
Time Frame: 2 weeks after initial treatment
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GRA (-3, -2, -1, 0, +1, +2, +3) of satisfaction by the patient
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2 weeks after initial treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Voiding and urodynamic parameters
Time Frame: 2 weeks after the initial treatment day
|
|
2 weeks after the initial treatment day
|
Collaborators and Investigators
Publications and helpful links
General Publications
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- Rajkumar GN, Small DR, Mustafa AW, Conn G. 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 Oct;96(6):848-52. doi: 10.1111/j.1464-410X.2005.05725.x.
- Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x. Erratum In: BJU Int 2001 Nov;88(7):807.
- Aoki KR. Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache. 2003 Jul-Aug;43 Suppl 1:S9-15. doi: 10.1046/j.1526-4610.43.7s.3.x.
- Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000 Jul;6(11 Suppl):S580-90.
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- Chen GD, Lin TL, Hu SW, Chen YC, Lin LY. Prevalence and correlation of urinary incontinence and overactive bladder in Taiwanese women. Neurourol Urodyn. 2003;22(2):109-17. doi: 10.1002/nau.10010.
- Homma Y, Yamaguchi O, Hayashi K; Neurogenic Bladder Society Committee. An epidemiological survey of overactive bladder symptoms in Japan. BJU Int. 2005 Dec;96(9):1314-8. doi: 10.1111/j.1464-410X.2005.05835.x.
- Kullmann FA, Artim DE, Birder LA, de Groat WC. Activation of muscarinic receptors in rat bladder sensory pathways alters reflex bladder activity. J Neurosci. 2008 Feb 20;28(8):1977-87. doi: 10.1523/JNEUROSCI.4694-07.2008.
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- Apostolidis A, Popat R, Yiangou Y, Cockayne D, Ford AP, Davis JB, Dasgupta P, Fowler CJ, Anand P. Decreased sensory receptors P2X3 and TRPV1 in suburothelial nerve fibers following intradetrusor injections of botulinum toxin for human detrusor overactivity. J Urol. 2005 Sep;174(3):977-82; discussion 982-3. doi: 10.1097/01.ju.0000169481.42259.54.
- Yiangou Y, Facer P, Ford A, Brady C, Wiseman O, Fowler CJ, Anand P. Capsaicin receptor VR1 and ATP-gated ion channel P2X3 in human urinary bladder. BJU Int. 2001 Jun;87(9):774-9. doi: 10.1046/j.1464-410x.2001.02190.x.
- Avelino A, Cruz F. TRPV1 (vanilloid receptor) in the urinary tract: expression, function and clinical applications. Naunyn Schmiedebergs Arch Pharmacol. 2006 Jul;373(4):287-99. doi: 10.1007/s00210-006-0073-2. Epub 2006 May 24.
- Popat R, Apostolidis A, Kalsi V, Gonzales G, Fowler CJ, Dasgupta P. 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 Sep;174(3):984-9. doi: 10.1097/01.ju.0000169480.43557.31.
- Kuo HC. Urodynamic evidence of effectiveness of botulinum A toxin injection in treatment of detrusor overactivity refractory to anticholinergic agents. Urology. 2004 May;63(5):868-72. doi: 10.1016/j.urology.2003.12.007.
- 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 Jun;177(6):2231-6. doi: 10.1016/j.juro.2007.01.130.
- Reitz A, Stohrer M, Kramer G, Del Popolo G, Chartier-Kastler E, Pannek J, Burgdorfer H, Gocking K, Madersbacher H, Schumacher S, Richter R, von Tobel J, Schurch B. European experience of 200 cases treated with botulinum-A toxin injections into the detrusor muscle for urinary incontinence due to neurogenic detrusor overactivity. Eur Urol. 2004 Apr;45(4):510-5. doi: 10.1016/j.eururo.2003.12.004.
- Kessler TM, Danuser H, Schumacher M, Studer UE, Burkhard FC. Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity? Neurourol Urodyn. 2005;24(3):231-6. doi: 10.1002/nau.20105.
- Schulte-Baukloh H, Weiss C, Stolze T, Sturzebecher B, Knispel HH. Botulinum-A toxin for treatment of overactive bladder without detrusor overactivity: urodynamic outcome and patient satisfaction. Urology. 2005 Jul;66(1):82-7. doi: 10.1016/j.urology.2005.01.036.
- Kuo HC. Clinical effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity refractory to anticholinergics. Urology. 2005 Jul;66(1):94-8. doi: 10.1016/j.urology.2005.02.002.
- Ghei M, Maraj BH, Miller R, Nathan S, O'Sullivan C, Fowler CJ, Shah PJ, Malone-Lee J. Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, double-blind, placebo controlled, crossover trial. J Urol. 2005 Nov;174(5):1873-7; discussion 1877. doi: 10.1097/01.ju.0000177477.83991.88.
- Sahai A, Sangster P, Kalsi V, Khan MS, Fowler CJ, Dasgupta P. Assessment of urodynamic and detrusor contractility variables in patients with overactive bladder syndrome treated with botulinum toxin-A: is incomplete bladder emptying predictable? BJU Int. 2009 Mar;103(5):630-4. doi: 10.1111/j.1464-410X.2008.08076.x. Epub 2008 Oct 16.
- White WM, Pickens RB, Doggweiler R, Klein FA. Short-term efficacy of botulinum toxin a for refractory overactive bladder in the elderly population. J Urol. 2008 Dec;180(6):2522-6. doi: 10.1016/j.juro.2008.08.030. Epub 2008 Oct 19.
- Brady CM, Apostolidis AN, Harper M, Yiangou Y, Beckett A, Jacques TS, Freeman A, Scaravilli F, Fowler CJ, Anand P. Parallel changes in bladder suburothelial vanilloid receptor TRPV1 and pan-neuronal marker PGP9.5 immunoreactivity in patients with neurogenic detrusor overactivity after intravesical resiniferatoxin treatment. BJU Int. 2004 Apr;93(6):770-6. doi: 10.1111/j.1464-410X.2003.04722.x.
- Brady CM, Apostolidis A, Yiangou Y, Baecker PA, Ford AP, Freeman A, Jacques TS, Fowler CJ, Anand P. P2X3-immunoreactive nerve fibres in neurogenic detrusor overactivity and the effect of intravesical resiniferatoxin. Eur Urol. 2004 Aug;46(2):247-53. doi: 10.1016/j.eururo.2003.12.017.
- Smet PJ, Moore KH, Jonavicius J. Distribution and colocalization of calcitonin gene-related peptide, tachykinins, and vasoactive intestinal peptide in normal and idiopathic unstable human urinary bladder. Lab Invest. 1997 Jul;77(1):37-49.
- Yoshida M, Miyamae K, Iwashita H, Otani M, Inadome A. Management of detrusor dysfunction in the elderly: changes in acetylcholine and adenosine triphosphate release during aging. Urology. 2004 Mar;63(3 Suppl 1):17-23. doi: 10.1016/j.urology.2003.11.003.
- Apostolidis A, Brady CM, Yiangou Y, Davis J, Fowler CJ, Anand P. Capsaicin receptor TRPV1 in urothelium of neurogenic human bladders and effect of intravesical resiniferatoxin. Urology. 2005 Feb;65(2):400-5. doi: 10.1016/j.urology.2004.10.007.
- Wiseman OJ, Fowler CJ, Landon DN. The role of the human bladder lamina propria myofibroblast. BJU Int. 2003 Jan;91(1):89-93. doi: 10.1046/j.1464-410x.2003.03802.x.
- Sui GP, Rothery S, Dupont E, Fry CH, Severs NJ. Gap junctions and connexin expression in human suburothelial interstitial cells. BJU Int. 2002 Jul;90(1):118-29. doi: 10.1046/j.1464-410x.2002.02834.x.
- Apostolidis A, Dasgupta P, Fowler CJ. Proposed mechanism for the efficacy of injected botulinum toxin in the treatment of human detrusor overactivity. Eur Urol. 2006 Apr;49(4):644-50. doi: 10.1016/j.eururo.2005.12.010. Epub 2006 Jan 4.
- Tyagi P, Wu PC, Chancellor M, Yoshimura N, Huang L. Recent advances in intravesical drug/gene delivery. Mol Pharm. 2006 Jul-Aug;3(4):369-79. doi: 10.1021/mp060001j.
- Giannantoni A, Di Stasi SM, Chancellor MB, Costantini E, Porena M. New frontiers in intravesical therapies and drug delivery. Eur Urol. 2006 Dec;50(6):1183-93; discussion 1193. doi: 10.1016/j.eururo.2006.08.025. Epub 2006 Aug 30.
- Giannantoni A, Porena M, Costantini E, Zucchi A, Mearini L, Mearini E. Botulinum A toxin intravesical injection in patients with painful bladder syndrome: 1-year followup. J Urol. 2008 Mar;179(3):1031-4. doi: 10.1016/j.juro.2007.10.032. Epub 2008 Jan 18.
- Kuo HC, Liu HT, Yang WC. Therapeutic effect of multiple resiniferatoxin intravesical instillations in patients with refractory detrusor overactivity: a randomized, double-blind, placebo controlled study. J Urol. 2006 Aug;176(2):641-5. doi: 10.1016/j.juro.2006.03.087.
- Birder LA. More than just a barrier: urothelium as a drug target for urinary bladder pain. Am J Physiol Renal Physiol. 2005 Sep;289(3):F489-95. doi: 10.1152/ajprenal.00467.2004.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
- incobotulinumtoxinA
Other Study ID Numbers
- TCGHUROL003
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