Clinical trial NCT03523091: OnabotulinumtoxinA Bladder Injection Study
Official title: Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Overactive Bladder
Overactive Bladder Syndrome
Urinary Urgency
Urinary Incontinence
Urinary Frequency/Urgency
Urinary Bladder, Overactive
Keywords: OnabotulinumtoxinA
Bladder Injections
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm parallel study with 1 to 1 randomization
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Incontinence Episodes Per Day
timeFrame: 3 months after the initial injection
Secondary outcomes:
measure: Degree of Bladder Symptom Bother
timeFrame: 3 months after the initial injection
measure: Severity of Urine Leakage
timeFrame: 3 months after the initial injection
measure: Change in Overactive Bladder Symptoms
timeFrame: 3 months after the initial injection
measure: Overall Patient Pain Tolerability With Treatment
timeFrame: After the initial injection
measure: Overall Voiding Symptoms at 3 Months
timeFrame: 3 months after the initial injection
measure: Safety of Bladder Injections
timeFrame: At study completion, 3 months after the initial injection
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital-Royal Oak
state: Michigan
Study officials:
affiliation: Beaumont Hospital-Royal Oak
name: Larry Sirls, MD
role: PRINCIPAL_INVESTIGATOR
References: