Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250543
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2024-01-18
Brief Title:
Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder
Sponsor:
Niko Kavcic
Organization:
University Medical Centre Maribor
Study Overview
Official Title:
Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA Efficacy and Safety in Women With Overactive Bladder and Urge Urinary Incontinence and the Value of Local Anesthesia for Pain Reduction
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized single blind non-inferiority clinical study was performed evaluating the efficacy and safety of AbobotulinumtoxinA vs IncobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence Also the effect of local anesthesia on pain level of the procedure was assessed
Detailed Description:
In the described prospective clinical trial approved by the National Medical Ethics Committee protocol number 0120-4420185 date of approval 22022018 female patients were enrolled followed by signed informed consent
Before treatment patients underwent history and physical examination Before botulinum toxin injection each patient completed three questionnaires UDI-6 Urogenital Distress Inventory IIQ-7 Incontinence Impact Questionnaire I-QOL Incontinence Quality of Life The total score of each questionnaire was considered Before botulinum toxin injection urinalysis was performed to check for a urinary tract infection UTI For those presenting with UTI treatment was postponed until the UTI was treated and a repeat urinalysis was performed Nitrofurantoin 100 mg twice daily per os was given prophylactically on the day of the procedure Patients were randomised to receive either 300 units of AbobotulinumtoxinA Dysport or 100 units of IncobotulinumtoxinA Xeomin They were further randomised to receive local anesthesia or placebo 30 minutes before the procedure the bladder was instilled with either 40 ml 1 lidocaine solution using a 16Fr urethral Foley catheter or with 40 ml 09 NaCl solution All patients received urethral lubrication gel Using rigid cystoscopy normal saline was used to dilute the vial to 20 ml A total of 20 evenly distributed intradetrusor injections 1 ml per site were performed 2 of them included the trigone area During the procedure the patients graded the pain level of every injection on a Visual Analog Scale VAS All patients were treated in an outpatient clinic and by one experienced surgeon
After 1 to 2 weeks patients were seen for evaluation of systemic side effects physical examination measurement of residual urine and urinalysis to eventually diagnose and treat a urinary tract infection After 4 months patients were seen to evaluate the treatment result and complete the questionnaires IIQ-7 UDI-6 patient satisfaction survey and I-QOL Side effects were monitored for 5 months after the procedure
Before treatment patients underwent history and physical examination Before botulinum toxin injection each patient completed three questionnaires UDI-6 Urogenital Distress Inventory IIQ-7 Incontinence Impact Questionnaire I-QOL Incontinence Quality of Life The total score of each questionnaire was considered Before botulinum toxin injection urinalysis was performed to check for a urinary tract infection UTI For those presenting with UTI treatment was postponed until the UTI was treated and a repeat urinalysis was performed Nitrofurantoin 100 mg twice daily per os was given prophylactically on the day of the procedure Patients were randomised to receive either 300 units of AbobotulinumtoxinA Dysport or 100 units of IncobotulinumtoxinA Xeomin They were further randomised to receive local anesthesia or placebo 30 minutes before the procedure the bladder was instilled with either 40 ml 1 lidocaine solution using a 16Fr urethral Foley catheter or with 40 ml 09 NaCl solution All patients received urethral lubrication gel Using rigid cystoscopy normal saline was used to dilute the vial to 20 ml A total of 20 evenly distributed intradetrusor injections 1 ml per site were performed 2 of them included the trigone area During the procedure the patients graded the pain level of every injection on a Visual Analog Scale VAS All patients were treated in an outpatient clinic and by one experienced surgeon
After 1 to 2 weeks patients were seen for evaluation of systemic side effects physical examination measurement of residual urine and urinalysis to eventually diagnose and treat a urinary tract infection After 4 months patients were seen to evaluate the treatment result and complete the questionnaires IIQ-7 UDI-6 patient satisfaction survey and I-QOL Side effects were monitored for 5 months after the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None