Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514430
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Prophylactic Analgesia for Bladder Botox Injections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prophylactic Analgesia in Outpatient Intradetrusor onabotulinumtoxinA Injections Efficacy and Feasibility of Alternative Pain Control Methods in a Diverse Urban Patient Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn more about using phenazopyridine Pyridium for pain control during bladder onabotulinumtoxinA botox injections for surgical management of overactive bladder OAB for patients at Montefiore Medical Center in The Bronx It will also learn about if using the phenazopyridine pill affects how satisfied patients are with their experience how much pain patients feel afterwards and if doctors think using the Pyridium pill affected how they performed the procedure The main question it aims to answer is
- Is oral phenazopyridine at least as good as intravesical lidocaine is for managing pain with bladder botox injections for OAB in Montefiore patients
Researchers will compare phenazopyridine to intravesical lidocaine a liquid put into the bladder to see if phenazopyridine is at least as good at controlling pain with bladder botox injections as intravesical lidocaine is
Participants will be assigned by chance to receive either the oral phenazopyridine pill or the intravesical lidocaine as their pain control for the procedure
- Is oral phenazopyridine at least as good as intravesical lidocaine is for managing pain with bladder botox injections for OAB in Montefiore patients
Researchers will compare phenazopyridine to intravesical lidocaine a liquid put into the bladder to see if phenazopyridine is at least as good at controlling pain with bladder botox injections as intravesical lidocaine is
Participants will be assigned by chance to receive either the oral phenazopyridine pill or the intravesical lidocaine as their pain control for the procedure
Detailed Description:
Urinary incontinence poses personal and emotional hardships to the patients who experience it Urge urinary incontinence UUI is often a result of overactive bladder OAB and may exist in combination with stress urinary incontinence SUI termed mixed urinary incontinence MUI Overall it is estimated that 25-45 of women experience some degree of urinary incontinence UI with increasing prevalence of UI symptoms as women age Treatment options for UI include expectant management behavioral modification pelvic floor physical therapy continence pessary vaginal inserts colposuspension or sling insertion as well as intradetrusor onabotulinumtoxinA botox injections and urethral bulking procedures
While intradetrusor onabotulinumtoxinA injection is a viable and effective option for OAB little is known about effective pain management for patients undergoing this procedure To date there has not yet been research on analgesia for bladder Botox injections in diverse urban populations whose needs and experience of pain may differ from those of other patients In recent years there has been renewed attention among patients and discussion within medical communities on the importance of examining biological sex gender racial and ethnic disparities in acute pain management
In this randomized controlled trial RCT the use of oral phenazopyridine compared to intravesical lidocaine as analgesic options for Montefiore patients undergoing surgical management of idiopathic overactive bladder with intradetrusor onabotulinumtoxinA Botox injections at the Department of Female Pelvic Medicine and Reconstructive Surgery in the Bronx will be studied Oral phenazopyridine is a pre-1938 FDA grandfathered drug that will be utilized in accordance with its indication for the treatment of urinary pain in the outpatient setting The use of these less invasive but effective analgesic options to manage pain for outpatient urogynecological procedures and their acceptability in a diverse urban patient population will be examined
All pain control options included in this study are within the standard of care for bladder Botox injections Participants will not have any alteration in their clinical care from what would be experienced if not participating in the study other than being randomized to one analgesia protocol
While intradetrusor onabotulinumtoxinA injection is a viable and effective option for OAB little is known about effective pain management for patients undergoing this procedure To date there has not yet been research on analgesia for bladder Botox injections in diverse urban populations whose needs and experience of pain may differ from those of other patients In recent years there has been renewed attention among patients and discussion within medical communities on the importance of examining biological sex gender racial and ethnic disparities in acute pain management
In this randomized controlled trial RCT the use of oral phenazopyridine compared to intravesical lidocaine as analgesic options for Montefiore patients undergoing surgical management of idiopathic overactive bladder with intradetrusor onabotulinumtoxinA Botox injections at the Department of Female Pelvic Medicine and Reconstructive Surgery in the Bronx will be studied Oral phenazopyridine is a pre-1938 FDA grandfathered drug that will be utilized in accordance with its indication for the treatment of urinary pain in the outpatient setting The use of these less invasive but effective analgesic options to manage pain for outpatient urogynecological procedures and their acceptability in a diverse urban patient population will be examined
All pain control options included in this study are within the standard of care for bladder Botox injections Participants will not have any alteration in their clinical care from what would be experienced if not participating in the study other than being randomized to one analgesia protocol
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