Clinical trial NCT06514430: Prophylactic Analgesia for Bladder Botox Injections
Official title: Prophylactic Analgesia in Outpatient Intradetrusor onabotulinumtoxinA Injections: Efficacy and Feasibility of Alternative Pain Control Methods in a Diverse Urban Patient Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Urinary Incontinence
Urinary Incontinence, Urge
Overactive Bladder
Keywords: onabotulinumtoxinA (Botox) injection
oral phenazopyridine
intravesical lidocaine
Urban Patient Population
Analgesia
Pain Management
Diverse Populations
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Women
* 18 years or older
* Planning to undergo surgical management of idiopathic overactive bladder with intradetrusor onabotulinumtoxinA injection at Montefiore Medical Center Female Pelvic Medicine Reconstructive Surgery Department
* Provided informed consent

Exclusion Criteria:

* Currently pregnant
* Current Urinary Tract Infection (UTI)
* Neurogenic bladder diagnosis
* Received pelvic radiotherapy
* Severe cognitive impairment
* Non-English or non-Spanish speaking.

Primary outcomes:
measure: Bladder Pain
timeFrame: Day of the procedure
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3 days post-procedure
measure: Bladder visualization
timeFrame: Day of the procedure
measure: Bladder Pain
timeFrame: 3 days post-operation
measure: Postoperative Analgesia
timeFrame: 3 days post-operation
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Female Pelvic Medicine Reconstructive Surgery Department
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Melissa Laudano, MD
role: PRINCIPAL_INVESTIGATOR
References: