The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder

January 22, 2018 updated by: AHMED FARAHAT HASSAN
To assess the efficacy of botulinum toxin in spastic neurogenic bladder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Ahmed Farahat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHMED FARAHAT HASSAN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

March 1, 2019

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

January 22, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • botox in neurogenic bladder

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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