The Efficacy of Botulinum Toxin in OVERACTIVE Bladder

Overactive Bladder Clinical Trial

Official title:

The Efficacy of Botulinum Toxin in OVERACTIVE Bladder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03888001
• Other study ID #: Botox in overactive bladder
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: AHMED FARAHAT, MASTER
• Phone: 01069569946
• Email: ahmedfarahat363[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the efficacy of botulinum toxin injection in overactive bladder.

Description:

Detrusor overactivity is defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase that may be spontaneous or provoked. Detrusor overactivity is subdivided into idiopathic detrusor overactivity and neurogenic detrusor overactivity The International Continence Society (ICS) defines OAB as the presence of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of UTI or other obvious pathology. Neurogenic detrusor overactivity (NDO) can result in lower and upper urinary tract complications and eventually even in end-stage kidney failure. Since the driving force of this clinical cascade is high bladder pressure, controlling intravesical pressure in NDO patients improves both quality of life and life-expectancy in these patients. Botulinum toxin A (BTX-A) has proven its efficacy in reducing intravesical pressure and in reducing incontinence episodes. BTX-A also improves quality of life in patients with NDO. Both onabotulinumtoxinA (Botox®, Allergan, Irvine, USA) and abobotulinumtoxinA (Dysport®, Ipsen, Paris, France) have a level A recommendation for NDO-treatment. The recommended dose for intradetrusor injections in NDO patients is 200 U of onabotulinumtoxinA or 500 U of abobotulinumtoxinA. The drug is generally administered extratrigonal in the detrusor muscle, via cystoscopic guided injection at 20 sites in 1 mL injections. Intradetrusor BTX-A injections are safe, with mostly local complications such as urinary tract infection and high post-void residual or retention. The effect of the toxin lasts for approximately 9 months. Repeat injections can be performed without loss of efficacy. Different injection techniques, novel ways of BTX-A administration, eliminating the need for injection or new BTX-A types with better/longer response rates could change the field in the future. Botulinum toxins are neurotoxins produced by the facultative anaerobe Clostridium botulinum that block the release of acetylcholine into the synaptic gap of the neuromuscular junction. Their injection near the nerves that supply the target organ selectively and temporarily paralyzes the organ. In particular, the subtype botulinum-A toxin is widely used in neurology to release spastic dystonia in adults. and children. In urologic disorders, botulinum-A toxin reliably diminishes external sphincter or detrusor overactivity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

1. Inclusion criteria:

• patients with spastic neurogenic bladder due to upper motor neuron lesion as (spinal cord lesions ,multiple sclerosis ,strokes,parkinsonism...........).

• patients with idiopathic overactive bladder

• patients with spastic neurogenic bladder diagnosed clinically and urodynamically.

2. Exclusion criteria:

• patients with diabetes mellitus.

• Atonic bladder.

• Children below 6 years.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
Egypt	Ahmed Farahat	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

1. Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci 2008;9:453-66. 2. Aoki KR, Guyer B. Botulinum toxin type A and other botulinum toxin serotypes: a comparative review of biochemical and pharmacological actions. Eur J Neurol 2001;8 Suppl 5:21-9. 3. Tanagho EA, McAninch JW, editors. Smith's General Urology. 17th ed. New York: The McGraw-Hill Companies, Inc., 2008,438-53. 4. Sellers DJ, McKay N. Developments in the pharmacotherapy of the overactive bladder. Curr Opin Urol2007;17:223-30. 5-Aoki, K.R. Pharmacology and immunology of botulinum toxin serotypes. J. Neurol. 2001; 248: 3-10

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Botulinum Toxin injection in overactive Bladder	By using of quistionaire mainly arabic validation of urogenital distress inventory ( UDI-6 quistionaire) throug appling quistions to patients that compare between symptoms before and after botox injection...	1 year