OnabotulinumtoxinA Bladder Injection Study

William Beaumont Hospitals

Status and phase: Terminated; Phase 4

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

Treatments: Drug: OnabotulinumtoxinA 100Unit Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03523091

2018-119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

3 Injection Sites

Experimental group

Description:

OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder

Treatment:

Drug: OnabotulinumtoxinA 100Unit Injection

10 Injection Sites

Experimental group

Description:

OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder

Treatment:

Drug: OnabotulinumtoxinA 100Unit Injection