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The Efficacy of Botulinum Toxin in OVERACTIVE Bladder

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ClinicalTrials.gov Identifier: NCT03888001
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
AHMED FARAHAT HASSAN, Assiut University

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

Condition or disease
Overactive Bladder

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Botulinum Toxin in OVERACTIVE Bladder
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Efficacy of Botulinum Toxin injection in overactive Bladder [ Time Frame: 1 year ]
    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...



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with either sex and above age of 6 years with diagnosis of idiopathic or neurogenic overactive bladder diagnosed clinically and urodynamically admitted to Assiut university hospital. Paitent with neurogenic lowcompliance or detrusor overactivity affecting bladder function
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888001


Contacts
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Contact: AHMED FARAHAT, MASTER 01069569946 ahmedfarahat363@yahoo.com
Contact: mahmoud FARAHAT, MASTER 01069569946 ahmedfarahat363@yahoo.com

Locations
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Egypt
Ahmed Farahat Recruiting
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: AHMED FARAHAT, MASTER Assiut University

Publications:
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

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Responsible Party: AHMED FARAHAT HASSAN, principle invistigator, Assiut University
ClinicalTrials.gov Identifier: NCT03888001     History of Changes
Other Study ID Numbers: Botox in overactive bladder
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs