Urinary IncontinencePhase 4NCT06514430
Prophylactic Analgesia for Bladder Botox Injections
A Phase 4 study testing Phenazopyridine and 1% lidocaine with sodium bicarbonate in people with Urinary Incontinence and Urinary Incontinence, Urge, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Urge, Overactive Bladder
- What is being tested?
- Phenazopyridine and 1% lidocaine with sodium bicarbonate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2025to Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently pregnant
- Current Urinary Tract Infection (UTI)
- Neurogenic bladder diagnosis
- Received pelvic radiotherapy
- Severe cognitive impairment
- Non-English or non-Spanish speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center Female Pelvic Medicine Reconstructive Surgery Department
The Bronx, New York, 10467
About this study
Official title: Prophylactic Analgesia in Outpatient Intradetrusor onabotulinumtoxinA Injections: Efficacy and Feasibility of Alternative Pain Control Methods in a Diverse Urban Patient Population
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?
Read more
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.
Read the 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.
- Being tested
- Phenazopyridine, 1% lidocaine with sodium bicarbonate
- Keywords
- onabotulinumtoxinA (Botox) injection, oral phenazopyridine, intravesical lidocaine, Urban Patient Population, Analgesia, Pain Management, Diverse Populations
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Urge, Urinary Bladder, Overactive, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenazopyridineDrug
Also called Pyridium
200mg PO Phenazopyridine taken prior to the Botox® injection procedure as an analgesic.
1% lidocaine with sodium bicarbonateDrug
Also called Intravesical lidocaine
50cc of 1% lidocaine with 50cc sodium bicarbonate injected into the bladder lumen prior to the Botox® injection procedure.
| Study group | Role | What they receive |
|---|---|---|
| Oral phenazopyridine | Active comparator | Patients randomized to the oral phenzopyridine arm will receive 200 milligrams (mg) phenazopyridine orally prior to the scheduled procedure. Receives: Drug: Phenazopyridine |
| Intravesical lidocaine | Active comparator | Patients randomized to the intravesical lidocaine arm will be administered 50 cubic centimeters (cc) of 1% lidocaine with 50cc sodium bicarbonate within the bladder immediately prior to the procedure. Receives: Drug: 1% lidocaine with sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Pain
Patient-reported bladder pain will be assessed using the Visual Analog Quality of Life Scale (VAS) tool. The VAS is a unidimensional measure of pain intensity. The 100mm VAS intervention tool consists of an emoji face scale ranging from an "open-mouth smile" emoji to a crying emoji. Patients will place an 'x' on the number line below the emojis to indicate where on the scale they would rate their pain, using the emoji faces as a guide. The distance from the lowest (farthest left) point on this scale to the 'x' will be measured and reported in millimeters. Higher scores are associated with increased levels of bladder pain intensity. Group median pain scores will be tabulated and reported.
Measured: Day of the procedure
Secondary outcomes (4)
Patient satisfaction
Overall patient satisfaction will be measured using a 5-point Likert scale range where 5 = very satisfied; 4 = satisfied; 3= neutral; 2 = unsatisfied; and 1 = very unsatisfied. Overall group mean patient satisfaction scores will be summarized and reported. Higher scores are associated with increased levels of patient satisfaction.
Measured: 3 days post-procedure
Bladder visualization
Physicians will be queried as to their perception of bladder visualization following the procedure, as oral phenazopyridine is known to temporarily stain the urine orange. Bladder visualization will be performed using cystoscopy to view the inside of the bladder during the procedure. Bladder visualization will be assessed on the following scale: 0 = clear, no difficulty; 1 = somewhat difficult / mildly impaired, 2 = very difficult.
Measured: Day of the procedure
Bladder Pain
Patient-reported bladder pain will be assessed using the Visual Analog Quality of Life Scale (VAS) tool. The VAS is a unidimensional measure of pain intensity. The 100mm VAS intervention tool consists of an emoji face scale ranging from an "open-mouth smile" emoji to a crying emoji. Patients will place an 'x' on the number line below the emojis to indicate where on the scale they would rate their pain, using the emoji faces as a guide. The distance from the lowest (farthest left) point on this scale to the 'x' will be measured and reported in millimeters. Higher scores are associated with increased levels of bladder pain intensity. Group median pain scores will be tabulated and reported.
Measured: 3 days post-operation
Postoperative Analgesia
Self-reported use of additional analgesia immediately following the procedure will be evaluated as 0 = no additional analgesia and 1 = any additional analgesia. The number of patients who require any additional postoperative analgesic will be summarized and reported.
Measured: 3 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study startJul 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: It was determined that it would be impracticable to conduct this study as a randomized trial. Study has been repurposed as a non-randomized study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Laudano, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514430
- Sponsor's protocol ID
- 2024-16001
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Analgesia in Outpatient Intradetrusor onabotulinumtoxinA Injections: Efficacy and Feasibility of Alternative Pain Control Methods in a Diverse Urban Patient Population
- ClinicalTrials.gov ID
- NCT06514430
- Acronym / sponsor ID
- 2024-16001
- Keywords
- onabotulinumtoxinA (Botox) injection, oral phenazopyridine, intravesical lidocaine, Urban Patient Population, Analgesia, Pain Management, Diverse Populations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was determined that it would be impracticable to conduct this study as a randomized trial. Study has been repurposed as a non-randomized study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral phenazopyridine | Active comparator | Drug: PhenazopyridinePatients randomized to the oral phenzopyridine arm will receive 200 milligrams (mg) phenazopyridine orally prior to the scheduled procedure. |
| Intravesical lidocaine | Active comparator | Drug: 1% lidocaine with sodium bicarbonatePatients randomized to the intravesical lidocaine arm will be administered 50 cubic centimeters (cc) of 1% lidocaine with 50cc sodium bicarbonate within the bladder immediately prior to the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Currently pregnant
- Current Urinary Tract Infection (UTI)
- Neurogenic bladder diagnosis
- Received pelvic radiotherapy
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenazopyridineAlso: Pyridium200mg PO Phenazopyridine taken prior to the Botox® injection procedure as an analgesic. | Drug | Oral phenazopyridine |
| 1% lidocaine with sodium bicarbonateAlso: Intravesical lidocaine50cc of 1% lidocaine with 50cc sodium bicarbonate injected into the bladder lumen prior to the Botox® injection procedure. | Drug | Intravesical lidocaine |
Primary outcome
Bladder Pain
Time frame: Day of the procedure
Patient-reported bladder pain will be assessed using the Visual Analog Quality of Life Scale (VAS) tool. The VAS is a unidimensional measure of pain intensity. The 100mm VAS intervention tool consists of an emoji face scale ranging from an "open-mouth smile" emoji to a crying emoji. Patients will place an 'x' on the number line below the emojis to indicate where on the scale they would rate their pain, using the emoji faces as a guide. The distance from the lowest (farthest left) point on this scale to the 'x' will be measured and reported in millimeters. Higher scores are associated with increased levels of bladder pain intensity. Group median pain scores will be tabulated and reported.
4 secondary outcomes
Patient satisfaction
Time frame: 3 days post-procedure
Bladder visualization
Time frame: Day of the procedure
Bladder Pain
Time frame: 3 days post-operation
Postoperative Analgesia
Time frame: 3 days post-operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Stress Urinary Incontinence (SUI)
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Laudano, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenazopyridine and 1% lidocaine with sodium bicarbonate in people with Urinary Incontinence and Urinary Incontinence, Urge, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Pain (time frame: Day of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.