Spastic Neurogenic BladderNCT03407183
The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder
An observational study of Spastic Neurogenic Bladder, run by AHMED FARAHAT HASSAN at 1 site in Egypt.
Trial summary
To assess the efficacy of botulinum toxin in spastic neurogenic bladder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spastic Neurogenic Bladder
- What is being tested?
- intradetrusor injection of botulinumtoxinA (Botox)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- -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.
Who cannot join
- 1-patients with associated lower motor neuron lesions. 2-atonic bladder. 3-patients with diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spastic Neurogenic Bladder
- Being tested
- intradetrusor injection of botulinumtoxinA (Botox)
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradetrusor injection of botulinumtoxinA (Botox)Procedure or surgery
intradetrusor injection of botulinumtoxinA (Botox®, Allergan, Irvine, USA) to assess the efficacy of Botox in treatment of neurogenic bladder.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: intradetrusor injection of botulinumtoxinA (Botox) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jan 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spastic Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHMED FARAHAT HASSAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AHMED FARAHAT HASSAN, Assiut University
- Investigators
- AHMED FARAHAT, master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407183
- Sponsor's protocol ID
- botox in neurogenic bladder
- Status last verified
- Jan 2018
- First submitted
- 29 Dec 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 10953127Kirschner 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder
- ClinicalTrials.gov ID
- NCT03407183
- Acronym / sponsor ID
- botox in neurogenic bladder
- Conditions
- Spastic Neurogenic Bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AHMED FARAHAT HASSANUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spastic neurogenic bladder | – | Procedure: intradetrusor injection of botulinumtoxinA (Botox)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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- -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.
Key exclusion criteria (1 listed)
- 1-patients with associated lower motor neuron lesions. 2-atonic bladder. 3-patients with diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intradetrusor injection of botulinumtoxinA (Botox)intradetrusor injection of botulinumtoxinA (Botox®, Allergan, Irvine, USA) to assess the efficacy of Botox in treatment of neurogenic bladder. | Procedure or surgery | spastic neurogenic bladder |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 10953127Schurch 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.
- Background: PubMed 11357236Kirschner 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED FARAHAT, master principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Neurogenic Bladder, run by AHMED FARAHAT HASSAN at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMED FARAHAT, MASTER (01069569946, ahmedfarahat363@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03407183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.