Overactive BladderPhase 4NCT03523091
OnabotulinumtoxinA Bladder Injection Study
A Phase 4 study testing OnabotulinumtoxinA 100Unit Injection in people with Overactive Bladder and Overactive Bladder Syndrome, run by Corewell Health East at 1 site in United States.
Trial summary
Patients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10 sites. Patient satisfaction and the effectiveness of the medication will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency
- What is being tested?
- OnabotulinumtoxinA 100Unit Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men, 18 years of age or older
- Self-reported failed conservative care of behavioral modifications and/or oral medications for the treatment of OAB
- Average urinary frequency of > 8 voids per day as recorded on initial 3-day voiding diary
- Self-reported bladder symptoms > 3 months
- Discontinued antimuscarinics/beta-3 agonists for > 2 weeks prior to study enrollment. May restart antimuscarinics/beta-3 agonists if indicated > 6 weeks after Botox injections.
- Capable of giving informed consent
- Capable and willing to follow all study-related procedures
- Previous OnabotulinumtoxinA injection at least three months prior to study enrollment.
Who cannot join
- Pregnant or planning to become pregnant during study duration
- Diagnosis of neurogenic bladder with the exception of highly functioning stroke patients
- If a patient has had a previous neuromodulation device placed, it will have to be turned off for 2 weeks for a washout period and remain off throughout the study
- Previous non-responders to onabotulinumtoxinA (BTX) therapy
- Patient cannot be receiving percutaneous nerve stimulation (PTNS) therapy. If patient is receiving PTNS, they need to stop for 1 month prior to entering the study.
- Refusal to self-catheterize or have indwelling catheter in the event of urinary retention
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- Use of investigational drug/device therapy within past 4 weeks
- Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks
- Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
- Pelvic radiation treatment
- Known hypersensitivity to OnabotulinumtoxinA.
- Previous infection at OnabotulinumtoxinA injection site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?
Patients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10 sites. Patient satisfaction and the effectiveness of the medication will be evaluated.
Read the detailed description
Overactive bladder (OAB) is a common condition which often has a negative impact on health related quality of life. Primary and secondary treatments include behavior modification, pelvic floor physical therapy, and OAB medications. OnabotulinumtoxinA (BTX) is a well-established third line therapy for refractory OAB.
BTX has transitioned over the years from a procedure conducted in the operating room to one that is commonly done in the clinic or physician office. While ten injection sites is commonly practiced, there has been continuing interest in reducing the number of injection sites to make the technique more tolerable and more efficient.
In this study, refractory OAB patients will be randomized to receive 100 units of BTX over 3 or 10 injection sites. The investigators hypothesize that decreasing the number of injection sites may improve patient tolerability and satisfaction with this office-based procedure and potentially reduce the rates of adverse events including hematuria and urinary tract infection.
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency, Urinary Incontinence, Urinary Frequency/Urgency, Urinary Bladder, Overactive
- Being tested
- OnabotulinumtoxinA 100Unit Injection
- Keywords
- OnabotulinumtoxinA, Bladder Injections
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA 100Unit InjectionDrug
Also called Botox
Initial treatment with the option of repeat injections every 3 months
| Study group | Role | What they receive |
|---|---|---|
| 3 Injection Sites | Experimental | OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder Receives: Drug: OnabotulinumtoxinA 100Unit Injection |
| 10 Injection Sites | Experimental | OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder Receives: Drug: OnabotulinumtoxinA 100Unit Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Incontinence Episodes Per Day
Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of voids over a 24 hour period for 3 consecutive days. Number of voids at 3 months are recorded.
Measured: 3 months after the initial injection
Secondary outcomes (6)
Degree of Bladder Symptom Bother
Per the Overactive Bladder Questionnaire-Short Form (OABq-SF). This validated measure evaluates overactive bladder symptom severity and health related quality of life. For each question, participants will answer how bothered they are by their urinary symptoms from "not at all" (1), "a little bit" (2), "somewhat" (3), "quite a bit" (4), "a great deal" (5), and "a very great deal" (5). Each question will be scored. Scores range from 19-114. The higher the score the greater perceived degree of bladder symptom bother.
Measured: 3 months after the initial injection
Severity of Urine Leakage
Per the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). This validated questionnaire provides a measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. Question items include frequency of urinary incontinence, amount of leakage, overall impact of urinary incontinence, and a self-diagnostic item. Scoring is between 0-21 with greater values indicating increased severity.
Measured: 3 months after the initial injection
Change in Overactive Bladder Symptoms
Per the Global Response Assessment (GRA). Participants will assess overall how their OAB symptoms/condition changed since starting the study. Participants will select, "Markedly worse" (1), "Moderately worse" (2), "Mildly worse" (3), "Same (unchanged)" (4), "Slightly improved" (5), "Moderately improved" (6), or "Markedly improved" (7). Scores are from 1-7 with a greater score indicating a greater improvement of symptoms. Numbers of participants reporting each assessment will be reported.
Measured: 3 months after the initial injection
Overall Patient Pain Tolerability With Treatment
Per the Visual Analog Scale (VAS). Participants will record the amount of pain of performing the treatment on a Visual Analog Scale from 0 (no pain) to 10 (worst pain imaginable). Visual analog scores will be gathered at the end of the injection visit.
Measured: After the initial injection
Overall Voiding Symptoms at 3 Months
Per the 3-day voiding diary. Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of voids, urge and stress incontinence episodes over a 24 hour period for 3 consecutive days.
Measured: 3 months after the initial injection
Safety of Bladder Injections
Frequency and severity of study-related adverse events
Measured: At study completion, 3 months after the initial injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start8 Aug 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies 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
- 2 arm parallel study with 1 to 1 randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Sirls, Corewell Health East
- Investigators
- Larry Sirls, MD, Principal investigator, Beaumont Hospital-Royal Oak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523091
- Sponsor's protocol ID
- 2018-119
- Status last verified
- Jan 2022
- First submitted
- 1 May 2018
- Last updated
- 10 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be available
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?
- ClinicalTrials.gov ID
- NCT03523091
- Acronym / sponsor ID
- 2018-119
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency, Urinary Incontinence, Urinary Frequency/Urgency, Urinary Bladder, Overactive
- Keywords
- OnabotulinumtoxinA, Bladder Injections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Posted 10 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10 sites. Patient satisfaction and the effectiveness of the medication will be evaluated.
Detailed description
Overactive bladder (OAB) is a common condition which often has a negative impact on health related quality of life. Primary and secondary treatments include behavior modification, pelvic floor physical therapy, and OAB medications. OnabotulinumtoxinA (BTX) is a well-established third line therapy for refractory OAB.
BTX has transitioned over the years from a procedure conducted in the operating room to one that is commonly done in the clinic or physician office. While ten injection sites is commonly practiced, there has been continuing interest in reducing the number of injection sites to make the technique more tolerable and more efficient.
In this study, refractory OAB patients will be randomized to receive 100 units of BTX over 3 or 10 injection sites. The investigators hypothesize that decreasing the number of injection sites may improve patient tolerability and satisfaction with this office-based procedure and potentially reduce the rates of adverse events including hematuria and urinary tract infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 arm parallel study with 1 to 1 randomization
| Arm | Type | Receives |
|---|---|---|
| 3 Injection Sites | Experimental | Drug: OnabotulinumtoxinA 100Unit InjectionOnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder |
| 10 Injection Sites | Experimental | Drug: OnabotulinumtoxinA 100Unit InjectionOnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women and men, 18 years of age or older
- Self-reported failed conservative care of behavioral modifications and/or oral medications for the treatment of OAB
- Average urinary frequency of > 8 voids per day as recorded on initial 3-day voiding diary
- Self-reported bladder symptoms > 3 months
- Discontinued antimuscarinics/beta-3 agonists for > 2 weeks prior to study enrollment. May restart antimuscarinics/beta-3 agonists if indicated > 6 weeks after Botox injections.
Key exclusion criteria (12 listed)
- Pregnant or planning to become pregnant during study duration
- Diagnosis of neurogenic bladder with the exception of highly functioning stroke patients
- If a patient has had a previous neuromodulation device placed, it will have to be turned off for 2 weeks for a washout period and remain off throughout the study
- Previous non-responders to onabotulinumtoxinA (BTX) therapy
- Patient cannot be receiving percutaneous nerve stimulation (PTNS) therapy. If patient is receiving PTNS, they need to stop for 1 month prior to entering the study.
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 |
|---|---|---|
| OnabotulinumtoxinA 100Unit InjectionAlso: BotoxInitial treatment with the option of repeat injections every 3 months | Drug | 10 Injection Sites, 3 Injection Sites |
Primary outcome
Number of Incontinence Episodes Per Day
Time frame: 3 months after the initial injection
Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of voids over a 24 hour period for 3 consecutive days. Number of voids at 3 months are recorded.
6 secondary outcomes
Degree of Bladder Symptom Bother
Time frame: 3 months after the initial injection
Severity of Urine Leakage
Time frame: 3 months after the initial injection
Change in Overactive Bladder Symptoms
Time frame: 3 months after the initial injection
Overall Patient Pain Tolerability With Treatment
Time frame: After the initial injection
Overall Voiding Symptoms at 3 Months
Time frame: 3 months after the initial injection
Safety of Bladder Injections
Time frame: At study completion, 3 months after the initial injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Participant data will not be available
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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.
Larry Sirls, MD principal investigator
Beaumont Hospital-Royal Oak
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 OnabotulinumtoxinA 100Unit Injection in people with Overactive Bladder and Overactive Bladder Syndrome, run by Corewell Health East 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Incontinence Episodes Per Day (time frame: 3 months after the initial injection). 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 10 Feb 2022.