Evaluation of the effect of intravaginal injection of Dysport on reducing the symptoms of overactive bladder, as a less invasive method compared to the conventional intravesical injection
evaluation the effect of intravaginal injection on reducing pain in patients with overactive bladder suffering from simultaneous chronic pelvic pain syndrome
Design
Two arm parallel groups clinical trial on 50 patients
Settings and conduct
Adult women with overactive bladder who referred to the urology clinic of Labbafinejad Hospital.
First group: after receiving regional or general anesthesia, the appropriate dose of Dysport (10 U/kg ) is diluted by normal saline (1 cc/100 units). The solution is injected into the detrusor at 20 different points with a special 22 gauge needle through cystoscope, and the Foley catheter is fixed.
Second group: local anesthesia is applied on an outpatient basis by lidocaine ,then the standard dose of Dysport is injected in 10 different points of anterior vaginal wall adjacent to the bladder with the fine 31 gauge needle. Foley catheter is not necessary.
For all patients, the ICIQ-OAB questionnaire will be completed before and 4 weeks after the intervention.
In patients with OAB and CPPS, the VAS-Score questionnaire is completed at the same time intervals.
Participants/Inclusion and exclusion criteria
Inclusion: Adult women with overactive bladder who are candidates for botulinum toxin injection.
Exclusion: Under 18 years old, Known cases of neurological defects, Active UTI, Intact hymen
Intervention groups
Control group: receiving Dysport by the standard intravesical method Intervention group: receiving Dysport by the new method of intravaginal injection
Main outcome variables
The rate of OAB symptoms reduction
The rate of pain reduction
Complications Rate: Hematuria, dysuria, infection, need for intermittent catheterization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211203053261N1
Registration date:2022-05-28, 1401/03/07
Registration timing:registered_while_recruiting
Last update:2022-05-28, 1401/03/07
Update count:0
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Maede Mohseni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0704
Email address
mao.mohseni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Overactive bladder(OAB) treatment by Intravaginal injection of botulinum toxin A (Dysport): An effective outpatient procedure
Public title
Overactive bladder treatment by Intravaginal injection of botulinum toxin A
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult women with overactive bladder who have not responded to initial medical treatment
Exclusion criteria:
Age under 18 years
patients with neurogenic bladder (known cases of neurological defects)
Active UTI
Women with intact Hymen
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of urology and nephrology research center, Shahid Beheshti university of medical sc
Street address
No 103, Boostan 9, Pasdaran AV, Tehran
City
Tehran
Province
Tehran
Postal code
16666663111
Approval date
2021-10-02, 1400/07/10
Ethics committee reference number
IR.SBMU.UNRC.REC.1400.005
Health conditions studied
1
Description of health condition studied
overactive bladder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ICIQ-OAB symptom score
Timepoint
Before and 4 weeks after intervention
Method of measurement
Validated questionnaire
Secondary outcomes
1
Description
Pain severity
Timepoint
Before and 4 weeks after intervention
Method of measurement
VAS score
2
Description
Incidence of gross hematuria
Timepoint
Within a week after the intervention
Method of measurement
View Foley catheter / Ask the patient
3
Description
Incidence of dysuria
Timepoint
Within a week after the intervention
Method of measurement
Ask the patient
4
Description
Incidence of UTI
Timepoint
Within a week after the intervention
Method of measurement
Urine culture
5
Description
Incidence of urinary retention and need for CIC
Timepoint
Within a week after the intervention
Method of measurement
Ultrasonography and ask the patient
Intervention groups
1
Description
Intervention group: Intravaginal Dysport (Abobotulinum toxin A, Ipsen Biop- harmaceuticals, Pharma, Germany) injection: In this group, local anesthesia is applied on an outpatient basis; diluted lidocaine is injected in to the anterior wall of the vagina at the lithotomy position. The standard dose of Dysport (10 units per kilogram of patient's body weight ) is then diluted by injectable normal saline (1 cc per 100 units) and injected into 10 points of the anterior vaginal wall, adjacent to the bladder, by an insulin syringe (very fine 31 gauge needle). Foley catheter is not necessary at the end of procedure.
Category
Treatment - Surgery
2
Description
Control group: Intravesical Dysport (Abobotulinum toxin A, Ipsen Biop- harmaceuticals, Pharma, Germany) injection: After regional or general anesthesia, cystoscopy and bladder washing are performed at the lithotomy position . The appropriate dose of Dysport, equivalent to 10 units per kilogram of patient weight (maximum 1000 units), is diluted with injectable normal saline (1 cc per 100 units). The final solution is injected into 20 different points of detrusor muscle by a special 22 gauge bladder injection needle (BoNee ;Coloplast, Humlebaek, Denmark) through cystoscope, and Foley catheter is fixed at the end of the procedure.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad medical center
Full name of responsible person
Farzaneh Sharifiaghdas
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2256 7222
Fax
+98 21 2256 7282
Email
mao.mohseni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Sharifiaghdas
Street address
No103, Boostan 9, Pasdaran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2256 7222
Fax
+98 21 2256 7282
Email
moa.mohseni@gmail.com
Grant name
Urology and Nephrology Research Center
Grant code / Reference number
0
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
Hamedan University of Medical Sciences
Full name of responsible person
Maede Mohseni
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Urology and Nephrology Research Center, Shahid Beheshti Hospital, Eram Boulevard, Hamadan,Iran
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0704
Email
mao.mohseni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maede Mohseni
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Urology and Nephrology Research Center, Shahid Beheshti Hospital, Eram Boulevard, Hamadan,Iran
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0704
Email
mao.mohseni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maede Mohseni
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Urology and Nephrology Research Center, Shahid Beheshti Hospital, Eram Boulevard, Hamadan,Iran
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0704
Email
mao.mohseni@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information will be entered as code in SPSS software and the analysis results will be published as a final report and article
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
According to the proposal, the data will be entered in accordance with the variables in SPSS software
When the data will become available and for how long
All information will be provided to the Research Center after the approval of the final report and preparation of the article
To whom data/document is available
Executors of the project
Under which criteria data/document could be used
If you need to continue the project with a larger sample size after preparing the proposal and approving it
From where data/document is obtainable
Urology and nephrology research center
What processes are involved for a request to access data/document
After the approval of the executor of the project and approval in the research council of the research center