Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01657409
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2012-08-02
Brief Title:
Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome
Sponsor:
Buddhist Tzu Chi General Hospital
Organization:
Buddhist Tzu Chi General Hospital
Study Overview
Official Title:
Comparison of the Therapeutic Effects of Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome
Status:
COMPLETED
Status Verified Date:
2017-02
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:
Overactive bladder OAB is a symptom syndrome characterized by urgency frequency with or without urge urinary incontinence UUI that may affect the patients quality of life Current medical treatments are usually unsuccessful in completely eradicating urgency sensation Intra-detrusor injection of botulinum toxin A BoNT-A modulates the release of neurotransmitters from sensory nerve endings and effectively modulates the inflammatory process mediated by nociceptive afferent nerve dysfunction Satisfactory clinical results were achieved with intravesical BoNT-A injection which increased bladder capacity and decreased urgency sensation in patients with neurogenic or idiopathic detrusor overactivity NDO IDO Excellent results were achieved with injection of either 100 U or 200 U of BoNT-A Episodes of frequency urgency and UUI were reduced maximal cystometric capacity increased maximal detrusor pressure Pdet decreased and the quality of life index also improved significantly However post void residual PVR volume increased significantly and some patients required clean intermittent catheterization CIC to evacuate the PVR Dose-related adverse events AE increased with increasing dose of BoNT-A Therefore adjustments of the BoNT-A dose and sites of injection might minimize the de novo AE and help to maintain success rates
Detailed Description:
This study was designed as a single blind randomized parallel actively controlled trial The urodynamic DO confirmed patients were randomly assigned to receive injection of onabotulinumtoxinA 100 U BoNT-A Allergan Irvine California USA which was reconstituted to 10 ml with normal saline for suburothelial injections in one of the three groups with the following injection number A 100 U in 10ml injections 10ml for each injection totally 10 injections at bladder body B 100 U in 10ml 05ml for each injection totally 20 injections at bladder body C 100 U in 10ml 025ml for each injection totally 40 injections at bladder body Permuted block randomization was used for this trial All treatments were evaluated at baseline and the primary end-point at 3 months
The inclusion criteria were patients of either gender aged 20 years or more with urodynamic DO and at least one episode of urgency urgency severity scale USS2 or UUI per day as recorded in the 3-day voiding diary Patients with neurogenic bladder urodynamically confirmed bladder outlet obstruction prior pelvic surgery anti-incontinence surgery or urinary tract infection UTI white blood cellWBC10high power field HPF in urinalysis were excluded Informed consent was obtained from all patients before randomization This study should be approved by the Institution Review Board and Ethics Committee of the hospital
All patients had been managed with behavioral modification and treated with a certain number of antimuscarinics for more than 4 weeks before they were enrolled into this trial Antimuscarinics was discontinued on the day of screening to wash out the remaining effect and obtaining a voiding diary that may reflect the true bladder condition
The injection method for each patient was not recorded in the operation note and the study nurse who controlled the outcome measures was blinded to the treatment assignment All procedures were performed transurethrally under intravenous general anesthesia in the operation room Anticoagulant was discontinued 1 week prior to onabotulinumtoxinA treatment The bladder volume was kept at 100-150 ml and the blood vessels were avoided during injections An indwelling Foley catheter was placed in the bladder overnight and the patients were discharged the next morning Broad-spectrum prophylactic antibiotics were given postoperatively for 3 days Patients who developed acute urinary retention AUR or PVR volumes greater than 250 ml were advised to perform CIC periodically to evacuate their bladders The patients were monitored at the outpatient clinic regularly for upto 24 months until symptoms returned to baseline levels
Videourodynamic study was routinely performed at baseline 3 and 6 months to measure urodynamic variables and detecting vesicoureteral reflux The measured urodynamic variables included maximum flow rate Qmax PVR cystometric bladder capacity CBC detrusor pressure at Qmax Pdet and voiding efficiency VE The procedure and definition of videourodynamic study were in accordance of the recommendations of the International Continence Society
The inclusion criteria were patients of either gender aged 20 years or more with urodynamic DO and at least one episode of urgency urgency severity scale USS2 or UUI per day as recorded in the 3-day voiding diary Patients with neurogenic bladder urodynamically confirmed bladder outlet obstruction prior pelvic surgery anti-incontinence surgery or urinary tract infection UTI white blood cellWBC10high power field HPF in urinalysis were excluded Informed consent was obtained from all patients before randomization This study should be approved by the Institution Review Board and Ethics Committee of the hospital
All patients had been managed with behavioral modification and treated with a certain number of antimuscarinics for more than 4 weeks before they were enrolled into this trial Antimuscarinics was discontinued on the day of screening to wash out the remaining effect and obtaining a voiding diary that may reflect the true bladder condition
The injection method for each patient was not recorded in the operation note and the study nurse who controlled the outcome measures was blinded to the treatment assignment All procedures were performed transurethrally under intravenous general anesthesia in the operation room Anticoagulant was discontinued 1 week prior to onabotulinumtoxinA treatment The bladder volume was kept at 100-150 ml and the blood vessels were avoided during injections An indwelling Foley catheter was placed in the bladder overnight and the patients were discharged the next morning Broad-spectrum prophylactic antibiotics were given postoperatively for 3 days Patients who developed acute urinary retention AUR or PVR volumes greater than 250 ml were advised to perform CIC periodically to evacuate their bladders The patients were monitored at the outpatient clinic regularly for upto 24 months until symptoms returned to baseline levels
Videourodynamic study was routinely performed at baseline 3 and 6 months to measure urodynamic variables and detecting vesicoureteral reflux The measured urodynamic variables included maximum flow rate Qmax PVR cystometric bladder capacity CBC detrusor pressure at Qmax Pdet and voiding efficiency VE The procedure and definition of videourodynamic study were in accordance of the recommendations of the International Continence Society
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None