The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder

Spastic Neurogenic Bladder Clinical Trial

Official title:

The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03407183
• Other study ID #: botox in neurogenic bladder
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2017
• Last updated: January 22, 2018
• Start date: January 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: AHMED FARAHAT, MASTER
• Phone: 01069569946
• Email: ahmedfarahat363[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spastic Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ahmed Farahat	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
AHMED FARAHAT HASSAN

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. Review. — View Citation

Schurch B, Stöhrer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year