OnabotulinumtoxinA Bladder Injection Study

Phase 4

Terminated

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

Interventions: Drug: OnabotulinumtoxinA 100Unit Injection

Registration Number: NCT03523091

Lead Sponsor: William Beaumont Hospitals

Brief 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 Injection Sites	OnabotulinumtoxinA 100Unit Injection	OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder
10 Injection Sites	OnabotulinumtoxinA 100Unit Injection	OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder

Primary Outcome Measures

Name	Time	Method
Number of Incontinence Episodes Per Day	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.

Secondary Outcome Measures

Name	Time	Method
Degree of Bladder Symptom Bother	3 months after the initial injection	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.
Severity of Urine Leakage	3 months after the initial injection	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.
Change in Overactive Bladder Symptoms	3 months after the initial injection	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.
Overall Patient Pain Tolerability With Treatment	After the initial injection	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.
Overall Voiding Symptoms at 3 Months	3 months after the initial injection	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.
Safety of Bladder Injections	At study completion, 3 months after the initial injection	Frequency and severity of study-related adverse events