Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437899
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-31
First Post:
2024-03-30
Brief Title:
Evaluation of Efficacy and Patient Satisfaction of Local Anaesthesia Versus Sedoanalgesia for Botox R Injection in the Urinary Bladder for the Treatment of Idiopathic Overactive Bladder
Sponsor:
Hospital LKH Hochsteiermark - Leoben
Organization:
Hospital LKH Hochsteiermark - Leoben
Study Overview
Official Title:
Evaluation of Efficacy and Patient Satisfaction Using Local Anaesthesia Versus Sedoanalgesia for Intradetrusor Botulinum-Toxin A Injection for the Treatment of Idiopathic Overactive Bladder a Randomized Controlled Non-inferiority Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
LA vs SA
Brief Summary:
Patients with symptoms of overactive bladder suffer from frequent micturition urinary incontinence and recurrent urinary tract infections Intravesical injections with botulinum toxin A can be used as a second-line therapy for this purpose
Intravesical botulinum toxin A injections can be performed under general anesthesia regional anesthesia sedoanalgesia and local anesthesia Which form of anesthesia is used varies greatly from region to region
As these patients are often elderly and morbid the lowest-risk and least stressful anesthesia method should be used The lowest-risk anesthesia method that can be used is local anesthesia Currently there are no guidelines that describe the use of standardized protocols for local anesthesia
The aim of this study is to show that the use of local anesthesia in this context is not inferior to the use of sedoanalgesia
All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study
The main outcome measure is pain secondary outcome measures are quality of life patient satisfaction incontinence score operation time and length of stay in the recovery room acceptance of repeating the procedure under local anesthesia satisfaction with the type of anesthesia method side effectscomplications and duration of inpatient stay
The study will be randomized into 2 arms local anesthesiasedoanalgesia with a 11 ratio to carry out the intravesical injection with botulinum toxin A
Intravesical botulinum toxin A injections can be performed under general anesthesia regional anesthesia sedoanalgesia and local anesthesia Which form of anesthesia is used varies greatly from region to region
As these patients are often elderly and morbid the lowest-risk and least stressful anesthesia method should be used The lowest-risk anesthesia method that can be used is local anesthesia Currently there are no guidelines that describe the use of standardized protocols for local anesthesia
The aim of this study is to show that the use of local anesthesia in this context is not inferior to the use of sedoanalgesia
All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study
The main outcome measure is pain secondary outcome measures are quality of life patient satisfaction incontinence score operation time and length of stay in the recovery room acceptance of repeating the procedure under local anesthesia satisfaction with the type of anesthesia method side effectscomplications and duration of inpatient stay
The study will be randomized into 2 arms local anesthesiasedoanalgesia with a 11 ratio to carry out the intravesical injection with botulinum toxin A
Detailed Description:
Urinary urgency symptoms with frequent micturition urinary incontinence nocturia and recurrent urinary tract infections are typical complaints of women with symptoms of an overactive bladder The level of suffering is usually very high Social withdrawal depressive moods frequent antibiotic use and financial burdens due to the increased need for incontinence products can be the result In accordance with the guideline-based treatment of idiopathic overactive bladder intravesical injection of botulinum toxin A can be offered after unsuccessful conservative first-line and second-line treatment Intravesical injection of botulinum toxin A has been approved for the treatment of idiopathic overactive bladder in Austria since 2013 Botulinum toxin A is a registered drug in Austria and is used for injection into the detrusor with 100IE according to its approval indication
Intravesical botulinum toxin A injections can be performed under general anesthesia regional anesthesia sedoanalgesia and local anesthesia Which form of anesthesia is used varies greatly from region to region The effectiveness of botulinum toxin A is limited in time Injections are repeated on average after 6-12 months Patients are often older and often have comorbidities Due to this and the potential need for repeated applications the procedure should be performed under general and regional anesthesia The use of local anesthesia as one of the anesthesia methods mentioned is considered to be very low-risk and the least stressful overall
Comparing the use of local anesthesia with the use of sedoanalgesia to perform the botulinum toxin A injection is equivalent to comparing two guideline-compliant standard treatments The confirmation of our hypothesis namely that performing the procedure under local anesthesia is equivalent to performing it under sedoanalgesia non-inferiority study could serve to optimize the treatment of overactive bladder patients and contribute to an increase in the level of health protection by strengthening the role of local anesthesia in the context of this procedure as an efficient option with the elimination of all anesthetic risks and as a first-choice procedure
All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study
The following examinations are carried out on all patients before inclusion in accordance with the examination standard of our department
Medical history age micturition frequency daynight urinary leakage sexuality amount drunk frequency of urinary tract infections previous treatments for incontinence parity secondary diseases diabetes mellitus obesity arterial hypertension central nervous diseases etc previous gynecological operations medication
Urogynecological examination
Urinalysis midstream urine
Urodynamics with stress test
Micturition protocol will be scanned
Standardized questionnaires to assess incontinence symptoms and quality of life
This is an open prospective randomized controlled non-inferiority study Patients participating in the study will be randomized into 2 arms local anesthesiasedoanalgesia with a 11 ratio Randomization will be done electronically wwwrandomizerat
The sample design was calculated based on a non-inferiority study with pain score evaluation as the primary endpoint
A sample size of 39 per group including expected drop-outs approximately 3 per group results in a required number of participants of 84
Intravesical botulinum toxin A injections can be performed under general anesthesia regional anesthesia sedoanalgesia and local anesthesia Which form of anesthesia is used varies greatly from region to region The effectiveness of botulinum toxin A is limited in time Injections are repeated on average after 6-12 months Patients are often older and often have comorbidities Due to this and the potential need for repeated applications the procedure should be performed under general and regional anesthesia The use of local anesthesia as one of the anesthesia methods mentioned is considered to be very low-risk and the least stressful overall
Comparing the use of local anesthesia with the use of sedoanalgesia to perform the botulinum toxin A injection is equivalent to comparing two guideline-compliant standard treatments The confirmation of our hypothesis namely that performing the procedure under local anesthesia is equivalent to performing it under sedoanalgesia non-inferiority study could serve to optimize the treatment of overactive bladder patients and contribute to an increase in the level of health protection by strengthening the role of local anesthesia in the context of this procedure as an efficient option with the elimination of all anesthetic risks and as a first-choice procedure
All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study
The following examinations are carried out on all patients before inclusion in accordance with the examination standard of our department
Medical history age micturition frequency daynight urinary leakage sexuality amount drunk frequency of urinary tract infections previous treatments for incontinence parity secondary diseases diabetes mellitus obesity arterial hypertension central nervous diseases etc previous gynecological operations medication
Urogynecological examination
Urinalysis midstream urine
Urodynamics with stress test
Micturition protocol will be scanned
Standardized questionnaires to assess incontinence symptoms and quality of life
This is an open prospective randomized controlled non-inferiority study Patients participating in the study will be randomized into 2 arms local anesthesiasedoanalgesia with a 11 ratio Randomization will be done electronically wwwrandomizerat
The sample design was calculated based on a non-inferiority study with pain score evaluation as the primary endpoint
A sample size of 39 per group including expected drop-outs approximately 3 per group results in a required number of participants of 84
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AUB | OTHER | AUB - Arbeitsgemeinschaft für Urogynäkologie Österreich | None |