Clinical trial NCT03407183: The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder
Official title: The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spastic Neurogenic Bladder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Farahat
Study officials:
affiliation: Assiut University
name: AHMED FARAHAT, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schurch B, Stohrer M, Kramer G, Schmid DM, Gaul G, Hauri D. Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs? Preliminary results. J Urol. 2000 Sep;164(3 Pt 1):692-7. doi: 10.1097/00005392-200009010-00018.
citation: Kirschner J, Berweck S, Mall V, Korinthenberg R, Heinen F. Botulinum toxin treatment in cerebral palsy: evidence for a new treatment option. J Neurol. 2001 Apr;248 Suppl 1:28-30. doi: 10.1007/pl00007815.