The Efficacy of Botulinum Toxin in OVERACTIVE Bladder

• Conditions: Overactive Bladder

• Registration Number: NCT03888001
• Lead Sponsor: Assiut University

Brief Summary

To assess the efficacy of botulinum toxin injection in 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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-21
• Last Update Submitted: 2019-03-21
• Study First Posted: 2019-03-25
• Last Update Posted: 2019-03-25
• Primary Completion: 2019-04-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Botulinum Toxin injection in overactive Bladder	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...

Trial Locations

Locations (1)

Ahmed Farahat; 🇪🇬 Assiut, Egypt