CClinicalTrials.gg
Status unknownNCT03407183Updated Jan 23, 2018

The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder

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

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Spastic Neurogenic Bladder
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

Exclusion Criteria:

  • 1-patients with associated lower motor neuron lesions. 2-atonic bladder. 3-patients with diabetes mellitus.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • spastic neurogenic bladder

    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)

Interventions

  • Procedureintradetrusor injection of botulinumtoxinA (Botox)

    intradetrusor injection of botulinumtoxinA (Botox®, Allergan, Irvine, USA) to assess the efficacy of Botox in treatment of neurogenic bladder.

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 of 1 sites recruiting
  • Ahmed Farahat
    Assiut, Egypt
    Recruiting
07

References and documents

Publications

  • 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. PubMed 10953127 ↗
  • 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. PubMed 11357236 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03407183
Lead sponsor
AHMED FARAHAT HASSAN
Responsible party
AHMED FARAHAT HASSAN (Principal Investigator, Assiut University) — Sponsor-investigator
First posted
Jan 23, 2018
Start date
Jan 1, 2018
Primary completion
Feb 1, 2019 (estimated)
Completion
Mar 1, 2019 (estimated)
Last update
Jan 23, 2018

Study contacts

AHMED FARAHAT, MASTER
Contact
ahmedfarahat363@yahoo.com
01069569946
mahmoud FARAHAT, MASTER
Contact
ahmedfarahat363@yahoo.com
01069569946
AHMED FARAHAT, master
principal investigator · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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