An observational study in Spastic Neurogenic Bladder, sponsored by AHMED FARAHAT HASSAN. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by AHMED FARAHAT HASSAN · Observational
To assess the efficacy of botulinum toxin in spastic neurogenic bladder.
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.
189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.
This study's planned enrollment of 20 is below the median of 71 across 57 observational studies indexed under Urinary Bladder, Neurogenic.
Browse Urinary Bladder, Neurogenic studies →This is the only study on the registry with AHMED FARAHAT HASSAN as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with spastic neurogenic bladder will be diagnosed clinically and urodynamically with preoperative assessment through:
.History. .Examination. .Urine analysis. .Abdominal ultrasound (to assess upper urinary tract and post micturation residual).
.Kidney function tests. .Urodynamic study. The patients will be re evaluated after 3 months post botulinum toxin injection regarding to previous items.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-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:
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.
Procedure: intradetrusor injection of botulinumtoxinA (Botox)
intradetrusor injection of botulinumtoxinA (Botox®, Allergan, Irvine, USA) to assess the efficacy of Botox in treatment of neurogenic bladder.
The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder
By improvement of symptoms and evaluation of urodynamic studies, Kidney function tests , abdominal ultrasound and urine analysis compared to preoperative results.
Time frame: 1 year
Plan to share: Undecided
Started Jan 2018 (actual). Primary completion is estimated for Feb 2019, 13 months after the start.
Of 26 observational studies under Urinary Bladder, Neurogenic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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