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The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03407183
Recruitment Status : Unknown
Verified January 2018 by AHMED FARAHAT HASSAN, Assiut University.
Recruitment status was:  Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
AHMED FARAHAT HASSAN, Assiut University

Study Description
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Brief Summary:
To assess the efficacy of botulinum toxin in spastic neurogenic bladder.

Condition or disease Intervention/treatment
Spastic Neurogenic Bladder Procedure: intradetrusor injection of botulinumtoxinA (Botox)

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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Groups and Cohorts
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Group/Cohort Intervention/treatment
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)
intradetrusor injection of botulinumtoxinA (Botox®, Allergan, Irvine, USA) to assess the efficacy of Botox in treatment of neurogenic bladder.


Outcome Measures
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Primary Outcome Measures :
  1. The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder [ Time Frame: 1 year ]
    By improvement of symptoms and evaluation of urodynamic studies, Kidney function tests , abdominal ultrasound and urine analysis compared to preoperative results.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407183


Contacts
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Contact: AHMED FARAHAT, MASTER 01069569946 ahmedfarahat363@yahoo.com
Contact: mahmoud FARAHAT, MASTER 01069569946 ahmedfarahat363@yahoo.com

Locations
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Egypt
Ahmed Farahat Recruiting
Assiut, Egypt
Sponsors and Collaborators
AHMED FARAHAT HASSAN
Investigators
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Principal Investigator: AHMED FARAHAT, master Assiut University
More Information
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Publications:

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Responsible Party: AHMED FARAHAT HASSAN, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03407183    
Other Study ID Numbers: botox in neurogenic bladder
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Muscle Spasticity
Urinary Bladder, Neurogenic
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
 Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases