This study is going to measure the effect of botulinum injection in children with neurogenic bladder for first time in iran.
Design
Clinical trial without control group
Settings and conduct
Patients who have the inclusion criteria, will be assessed by primary urodynamic study after registering the demographic index. Consequently, endoscopic Botox injection will be done by a single surgeon under general anesthesia in Operating room. Secondary urodynamic study will be done after 3 months and the results will be compared.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children ,affected with Spastic Neurogenic Bladder, who are referred to Mofid Sub specialty Children's Hospital ,and are under treatment with clean intermittent catheterization, and maximal medical therapy by anticholinergic drugs ,and revealed drug related complications ,or resistance
Exclusion Criteria: Patients who have been undergone prior bladder augmentation surgery,
Patients who their parents or their legal guardian don't accept their study enrollment
Intervention groups
Botulinum injection is going to be done under the general anesthesia with rigid cystoscope and endoscopic needle for all of the patients.
To modify the botulinum concentration it will be diluted with normal salin and
in order to inject accurately a small amount of methylen blue will be used. Approximately 10 unit of botulinum toxin will be injected in anterior and posterior detrussor wall without injection into the trigon .
Administered botulinum dosage will be 10 U/kg with the maximum dose of 300 units.
Manufacturer company: Ipsen Biopharm Ltd,UK
Main outcome variables
Bladder capacity after injection,
Hours not demanding diaper change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181124041743N1
Registration date:2019-02-12, 1397/11/23
Registration timing:retrospective
Last update:2019-02-12, 1397/11/23
Update count:0
Registration date
2019-02-12, 1397/11/23
Registrant information
Name
Saran Lotfollahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 6122
Email address
s.lotfollahzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-30, 1397/09/09
Expected recruitment end date
2019-01-15, 1397/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Botulinum toxin injection in pediatric population affected by spastic neuropathic bladder resistant to medical therapy
Public title
Botulinum toxin injection in pediatric population with spastic neuropathic bladder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under the age of 18
Affected with Spastic Neurogenic Bladder
Refer to Mofid Children's Hospital
Under treatment with Clean Intermittent Catheterization
Under treatment with maximal medical therapy with anti-cholinergic drugs
Reveal anti-cholinergic drugs related complications
Reveal anti-cholinergic drugs resistance
Exclusion criteria:
Patients who have been undergone prior bladder augmentation surgery
Patients that their parents or their legal guardian don't accept their study enrollment
Age
To 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti university of medical sciences
Street address
Koudakyar str, daneshjou blv
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.SBMU.MSP.REC.1397.593
Health conditions studied
1
Description of health condition studied
Neurogenic bladder
ICD-10 code
N31.9
ICD-10 code description
Neuromuscular dysfunction of bladder, unspecified
2
Description of health condition studied
Neurogenic bladder dysfunction due to cauda equina syndrom
ICD-10 code
G95.8
ICD-10 code description
Other specified diseases of spinal cord
Primary outcomes
1
Description
Bladder capacity after injection.
Timepoint
Before intervention and 3 months after that
Method of measurement
Mofid children Hospital urodynamic measurement device ,model DELPHIS IP, MODEL: 94_RO1P_BT;Manufactured by LABORIE MEDICAL TECHNOLOGIES.
2
Description
Hours of not demanding diaper change
Timepoint
Before and 3 months after Botox injection
Method of measurement
Interview with parents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who have the inclusion criteria to enrol the study,first will undergo primary urodynamic study with DELPHIS IP,MODEL 94_RO1P_BT manufactured by LABORIE MEDICAL TECHNOLOGIES and interview with parents.Bladder volume and number of hours not demanding diaper change will be registered. After that Botox manufactured by Ipsen Biopharm Ltd UK with the amount of 10u/kg and maximal dose of 300units will be injected in Operating room under general anesthesia with rigid cystoscope by one surgeon.Site of injection is in detrusor muscles along with anterior and posterior far from trigon. Three months later, repeated urodynamic study with the same primary device and interview with parents will be done and bladder volume and hours not demanding diaper change will be recorded, respectively.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children Hospital
Full name of responsible person
Saran Lotfollahzadeh
Street address
Shariati str- Mirdamad intersection
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
koudakyar str, daneshjou blv
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Fax
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saran Lotfollahzadeh
Position
Pediatric surgery fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shariati str,Mirdamad Intersection
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Fax
+98 21 2222 0254
Email
S.lotfollahzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saran Lotfallahzadeh
Position
Pediatric surgery fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shariati str,Mirdamad Intersection
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
s.lotfollahzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saran Lotfollahzadeh
Position
Pediatric surgery fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shariati str, Mirdamad Intersection
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Fax
+98 21 2222 0254
Email
S.lotfollahzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available