Overactive Bladder SyndromePhase 4OPILNCT03755089
Oral vs Intravesical Analgesia for Office Bladder Botox Injections
A Phase 4 study testing Phenazopyridine and Lidocaine 2% Injectable Solution in people with Overactive Bladder Syndrome and Urge Incontinence, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence
- What is being tested?
- Phenazopyridine and Lidocaine 2% Injectable Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 1 Mar 2021
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant, adult females 18 years of age or older
- Diagnosis of idiopathic overactive bladder
- Planning office-based bladder injection of onabotulinumtoxinA
- Willing and able to complete all study related items and interviews
- Grossly neurologically normal on exam
Who cannot join
- Known neurologic diseases (multiple sclerosis, Parkinson Disease, CVA within 6 months, myasthenia gravis, Charcot-Marie-Tooth disease, peripheral neuropathy, and complete spinal cord injury) believed to affect urinary function
- Planned injection of >100 units of onabotulinumtoxinA
- OnabotulinumtoxinA given for another indication within the previous 3 months (if cumulative dose would total >400 units)
- Any intradetrusor onabotulinumtoxinA injections in the previous 12 months
- Serum creatinine level greater than twice the upper limit of normal within the year prior to enrollment
- Allergy to lidocaine
Show all 16Show fewer
- Allergy to onabotulinumtoxinA
- Allergy to phenazopyridine
- Untreated urinary tract infection (UTI)
- Currently pregnant or lactating.
- Known urinary retention (post-void residual >200mL) and inability to perform intermittent self-catheterization
- Uninvestigated hematuria (gross or microscopic)
- Current or prior bladder malignancy
- Previous bladder augmentation or surgically altered detrusor muscle
- Prior pelvic radiation
- Primary language other than English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
Lauren E Stewart, MD, 401-453-7560 ext. 48762, lstewart@wihri.org
About this study
Official title: Oral Phenazopyridine Versus Intravesical Lidocaine for Office OnabotulinumtoxinA Analgesia: A Randomized Controlled Trial
OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. The goal of this study is to determine which medication is better at providing comfort during bladder Botox® injections.
Read the detailed description
The primary aim of this randomized clinical trial is to compare the analgesic effect of oral phenazopyridine to that of intravesical lidocaine during intradetrusor injections of onabotulinumtoxinA performed for idiopathic overactive bladder. The investigators will achieve this by measuring the mean visual-analog pain scores (VAS) in women who are randomized to receive either oral phenazopyridine or intravesical lidocaine.
Secondary aims include assessment of:
- Overall Patient Satisfaction: To compare overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.
- Ease of Procedure: To compare the physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.
- Office Efficiency/Total Appointment Duration: To compare total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.
- Conditions
- Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence, Detrusor Hyperreflexia, Detrusor Instability
- Being tested
- Phenazopyridine, Lidocaine 2% Injectable Solution
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenazopyridineDrug
200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure
Lidocaine 2% Injectable SolutionDrug
30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes 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 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure. Receives: Drug: Phenazopyridine |
| Intravesical Lidocaine | Active comparator | Patients randomized to the intravesical lidocaine arm will have the bladder back-filled with 30mL 2% lidocaine for the 20 minutes immediately preceding their procedure. Receives: Drug: Lidocaine 2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Effect Measured with 100mm Visual Analog Scale
The visual analog scale is a visual representation of pain severity rated from 0 (no pain) to 10 (worst pain imaginable). Therefore higher numbers represent more pain.The scale is represented visually using a 100 millimeter line and patients indicate their level of pain by pointing to a location on the line.
Measured: Immediately post-procedure
Secondary outcomes (3)
Overall Patient Satisfaction
Overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. Overall satisfaction will be measured with a single-item question utilizing a Likert scale with options ranging from very satisfied to very unsatisfied.
Measured: Immediately post-procedure
Ease of Procedure
Physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured with a single item, five point Likert scale with options ranging from no difficulty to great difficulty.
Measured: Immediately post-procedure
Office Efficiency/Total Appointment Duration
Total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured by subtracting the appointment start time (time the patient was placed in the exam room) from the appointment end time (time of patient check-out).
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Nov 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren E Stewart, MD, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755089
- Sponsor's protocol ID
- 1258364-2
- Acronym
- OPIL
- Status last verified
- May 2020
- First submitted
- 26 Nov 2018
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart LE, Siddique M, Jacobs KM, Raker CA, Sung VW. Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial. Am J Obstet Gynecol. 2022 Aug;227(2):308.e1-308.e8. doi: 10.1016/j.ajog.2022.05.025. Epub 2022 May 14.
PubMed 35580634
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Phenazopyridine Versus Intravesical Lidocaine for Office OnabotulinumtoxinA Analgesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03755089
- Acronym / sponsor ID
- OPIL / 1258364-2
- Conditions
- Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence, Detrusor Hyperreflexia, Detrusor Instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 27 Nov 2018 (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.
OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. The goal of this study is to determine which medication is better at providing comfort during bladder Botox® injections.
Detailed description
The primary aim of this randomized clinical trial is to compare the analgesic effect of oral phenazopyridine to that of intravesical lidocaine during intradetrusor injections of onabotulinumtoxinA performed for idiopathic overactive bladder. The investigators will achieve this by measuring the mean visual-analog pain scores (VAS) in women who are randomized to receive either oral phenazopyridine or intravesical lidocaine.
Secondary aims include assessment of:
- Overall Patient Satisfaction: To compare overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.
- Ease of Procedure: To compare the physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.
- Office Efficiency/Total Appointment Duration: To compare total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.
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 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure. |
| Intravesical Lidocaine | Active comparator | Drug: Lidocaine 2% Injectable SolutionPatients randomized to the intravesical lidocaine arm will have the bladder back-filled with 30mL 2% lidocaine for the 20 minutes immediately preceding their procedure. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-pregnant, adult females 18 years of age or older
- Diagnosis of idiopathic overactive bladder
- Planning office-based bladder injection of onabotulinumtoxinA
- Willing and able to complete all study related items and interviews
- Grossly neurologically normal on exam
Key exclusion criteria (16 listed)
- Known neurologic diseases (multiple sclerosis, Parkinson Disease, CVA within 6 months, myasthenia gravis, Charcot-Marie-Tooth disease, peripheral neuropathy, and complete spinal cord injury) believed to affect urinary function
- Planned injection of >100 units of onabotulinumtoxinA
- OnabotulinumtoxinA given for another indication within the previous 3 months (if cumulative dose would total >400 units)
- Any intradetrusor onabotulinumtoxinA injections in the previous 12 months
- Serum creatinine level greater than twice the upper limit of normal within the year prior to enrollment
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 |
|---|---|---|
| Phenazopyridine200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure | Drug | Oral Phenazopyridine |
| Lidocaine 2% Injectable Solution30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure | Drug | Intravesical Lidocaine |
Primary outcome
Analgesic Effect Measured with 100mm Visual Analog Scale
Time frame: Immediately post-procedure
The visual analog scale is a visual representation of pain severity rated from 0 (no pain) to 10 (worst pain imaginable). Therefore higher numbers represent more pain.The scale is represented visually using a 100 millimeter line and patients indicate their level of pain by pointing to a location on the line.
3 secondary outcomes
Overall Patient Satisfaction
Time frame: Immediately post-procedure
Ease of Procedure
Time frame: Immediately post-procedure
Office Efficiency/Total Appointment Duration
Time frame: Immediately post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Derived from this study: PubMed 35580634Stewart LE, Siddique M, Jacobs KM, Raker CA, Sung VW. Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial. Am J Obstet Gynecol. 2022 Aug;227(2):308.e1-308.e8. doi: 10.1016/j.ajog.2022.05.025. Epub 2022 May 14.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder Syndrome
Active, not recruitingPhase 2/3
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Tensi+ for Treating Overactive Bladder
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Improving Overactive Bladder Treatment Access and Adherence
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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.
Lauren E Stewart, MD principal investigator
Women and Infants Hospital of Rhode Island
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 Lidocaine 2% Injectable Solution in people with Overactive Bladder Syndrome and Urge Incontinence, run by Women and Infants Hospital of Rhode Island 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren E Stewart, MD (401-453-7560 ext. 48762, lstewart@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic Effect Measured with 100mm Visual Analog Scale (time frame: Immediately post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755089, which also lists 1 linked publication.
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 29 May 2020.