OnabotulinumtoxinA Bladder Injection Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?

Conditions
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Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency, Urinary Incontinence, Urinary Frequency/Urgency, Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: OnabotulinumtoxinA 100Unit Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arm parallel study with 1 to 1 randomization
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 Injection Sites<br>OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder | Drug: OnabotulinumtoxinA 100Unit Injection<br>* Initial treatment with the option of repeat injections every 3 months<br>* Other names: Botox;|
| Experimental: 10 Injection Sites<br>OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder | Drug: OnabotulinumtoxinA 100Unit Injection<br>* Initial treatment with the option of repeat injections every 3 months<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after the initial injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 3 months after the initial injection | 
| Safety of Bladder Injections | Frequency and severity of study-related adverse events | At study completion, 3 months after the initial injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OnabotulinumtoxinA, Bladder Injections