Overactive Bladder SyndromePhase 4NCT05157295
Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial
A Phase 4 study testing OnabotulinumtoxinA in people with Overactive Bladder Syndrome and Overactive Bladder, run by Augusta University.
Trial summary
Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome, Overactive Bladder
- What is being tested?
- OnabotulinumtoxinA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Sep 2022
- 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
- females, adults 18 years of age and older, diagnosed with OAB
Who cannot join
- bladder pathology including nephrolithiasis, active urinary tract infection, bladder trauma, neurogenic bladder, patients who have previously received intravesical onabotulinumtoxin A injections, pregnant patients, minor patients, male patients
Trial locations and contacts
No sites are listed yet.
About this study
Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Current standard of practice involves 100 U of onabotulinumtoxinA diluted in 10 ml saline cystoscopically injected into approximately 20 different detrusor muscle sites equally distributed along the posterior bladder wall and dome. This treatment was classically done in the operating room under general anesthesia, but now is typically performed in an office setting using local anesthesia (lidocaine) as this is more feasible and tolerable. Patients can experience discomfort and pain with each injection. Evidence has also shown that administering the same dose of onabotulinumtoxinA into fewer injection sites in the detrusor muscle (ranging from 3 to 10) results in equivalent efficacy compared to the current standard. However, it has yet to be determined if there is a significant difference in patient satisfaction and tolerability when the procedure is administered in an office setting using the same dosage with fewer injections. Our study aims to assess whether patient tolerance and satisfaction of intravesicular onabotulinumtoxinA increases with the use of 4 detrusor injections as opposed to 20 injections when performed in an office setting on women with OAB.
- Conditions
- Overactive Bladder Syndrome, Overactive Bladder
- Being tested
- OnabotulinumtoxinA
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 4 different detrusor muscle sites along the posterior bladder wall and dome. Receives: Drug: OnabotulinumtoxinA |
| Control Group | Active comparator | 100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 20 different detrusor muscle sites along the posterior bladder wall and dome. Receives: Drug: OnabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain of each participant before, during, and after the procedure on a scale of 0-10
The Pain Survey is a self-reported instrument used to assess pain before, during, and after a procedure. Possible scores range from 0 (no pain) to 10 (worst pain possible).
Measured: within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention
Secondary outcomes (3)
The Benefit, Satisfaction, and Willingness to Continue of each participant after the procedure
The Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire is a validated instrument administered by the physician. It asks participants if they had benefit, satisfaction, and a willingness to continue from a specific treatment. If yes, responses range from 1(little benefit, little, satisfaction, a little bit willing) to 2(much benefit, very satisfied, very willing).
Measured: 2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure
Change in extent of Overactive Bladder Symptoms before and after receiving the procedure
The Overactive Bladder questionnaire (OAB-q) short form is a validated instrument that measures the extent to which participants have various symptoms of OAB over the past 4 weeks. The responses range from 1(not at all) to 6(a very great deal).
Measured: Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
The Prevalence of complications with botox after receiving the procedure
The Complications with Botox survey is an instrument used to measure if and how many times participants experienced UTIs, difficulty urinating, or hematuria after the Botox procedure. Participants self-report the number of times if they have experienced the side effect.
Measured: 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- One group of participants will receive the "experimental" treatment, which is 4 injections, and the other group of participants will receive the "standard" treatment, which is 20 injections.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Lanzer, MD, Principal investigator, Augusta UniversityEmily Grandprey, DO, Study director, Augusta UniversityEmily Lluch, Study director, Augusta UniversityAhana Gaurav, Study director, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157295
- Sponsor's protocol ID
- 1791493
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 15 Dec 2021
- 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 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05157295
- Acronym / sponsor ID
- 1791493
- Conditions
- Overactive Bladder Syndrome, Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 15 Dec 2021 (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.
Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Current standard of practice involves 100 U of onabotulinumtoxinA diluted in 10 ml saline cystoscopically injected into approximately 20 different detrusor muscle sites equally distributed along the posterior bladder wall and dome. This treatment was classically done in the operating room under general anesthesia, but now is typically performed in an office setting using local anesthesia (lidocaine) as this is more feasible and tolerable. Patients can experience discomfort and pain with each injection. Evidence has also shown that administering the same dose of onabotulinumtoxinA into fewer injection sites in the detrusor muscle (ranging from 3 to 10) results in equivalent efficacy compared to the current standard. However, it has yet to be determined if there is a significant difference in patient satisfaction and tolerability when the procedure is administered in an office setting using the same dosage with fewer injections. Our study aims to assess whether patient tolerance and satisfaction of intravesicular onabotulinumtoxinA increases with the use of 4 detrusor injections as opposed to 20 injections when performed in an office setting on women with OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group of participants will receive the "experimental" treatment, which is 4 injections, and the other group of participants will receive the "standard" treatment, which is 20 injections.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: OnabotulinumtoxinA100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 4 different detrusor muscle sites along the posterior bladder wall and dome. |
| Control Group | Active comparator | Drug: OnabotulinumtoxinA100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 20 different detrusor muscle sites along the posterior bladder wall and dome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- females, adults 18 years of age and older, diagnosed with OAB
Key exclusion criteria (1 listed)
- bladder pathology including nephrolithiasis, active urinary tract infection, bladder trauma, neurogenic bladder, patients who have previously received intravesical onabotulinumtoxin A injections, pregnant patients, minor patients, male patients
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 |
|---|---|---|
| OnabotulinumtoxinA100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites | Drug | Control Group, Experimental Group |
Primary outcome
Perceived pain of each participant before, during, and after the procedure on a scale of 0-10
Time frame: within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention
The Pain Survey is a self-reported instrument used to assess pain before, during, and after a procedure. Possible scores range from 0 (no pain) to 10 (worst pain possible).
3 secondary outcomes
The Benefit, Satisfaction, and Willingness to Continue of each participant after the procedure
Time frame: 2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure
Change in extent of Overactive Bladder Symptoms before and after receiving the procedure
Time frame: Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
The Prevalence of complications with botox after receiving the procedure
Time frame: 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder Syndrome
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
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Migraine Medication Effects on Urinary Symptoms
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Tensi+ for Treating Overactive Bladder
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Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
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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.
Jennifer Lanzer, MD principal investigator
Augusta University
Emily Grandprey, DO study director
Augusta University
Emily Lluch study director
Augusta University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OnabotulinumtoxinA in people with Overactive Bladder Syndrome and Overactive Bladder, run by Augusta University.
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 1 inclusion and 1 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 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Stacy Carrigan (7067214959, scarrigan@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived pain of each participant before, during, and after the procedure on a scale of 0-10 (time frame: within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention). 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 15 Dec 2021.