The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder

• Conditions: Spastic Neurogenic Bladder
• Interventions: Procedure: intradetrusor injection of botulinumtoxinA (Botox)

• Registration Number: NCT03407183
• Lead Sponsor: AHMED FARAHAT HASSAN

Brief Summary

To assess the efficacy of botulinum toxin in spastic neurogenic bladder.

Detailed Description

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 First Submitted: 2017-12-29
• Status Verified: 2018-01
• Study Start: 2018-01-01
• Study First Submitted QC: 2018-01-22
• Last Update Submitted: 2018-01-22
• Study First Posted: 2018-01-23
• Last Update Posted: 2018-01-23
• Primary Completion: 2019-02-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

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

Inclusion Criteria

-1- patients with spastic neurogenic bladder due to upper motor neuron lesion as (spinal cord lesions ,multiple sclerosis ,strokes,parkinsonism...........).

2- patients with spastic neurogenic bladder diagnosed clinically and urodynamically.

Exclusion Criteria

• 1-patients with associated lower motor neuron lesions. 2-atonic bladder. 3-patients with diabetes mellitus.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
spastic neurogenic bladder	intradetrusor injection of botulinumtoxinA (Botox)	intradetrusor injection of botulinumtoxinA (Botox®, Allergan, Irvine, USA) in patients with spastic neurogenic bladder is 200 U of onabotulinumtoxinA once, then follow up after three months.

Primary Outcome Measures

Name	Time	Method
The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder	1 year	By improvement of symptoms and evaluation of urodynamic studies, Kidney function tests , abdominal ultrasound and urine analysis compared to preoperative results.

Trial Locations

Locations (1)

Ahmed Farahat; 🇪🇬 Assiut, Egypt