OnabotulinumtoxinA Bladder Injection Study

NCT ID: NCT03523091

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2020-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3 Injection Sites

OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder

Group Type: EXPERIMENTAL

OnabotulinumtoxinA 100Unit Injection

Intervention Type: DRUG

Initial treatment with the option of repeat injections every 3 months

10 Injection Sites

OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder

Group Type: EXPERIMENTAL

OnabotulinumtoxinA 100Unit Injection

Intervention Type: DRUG

Initial treatment with the option of repeat injections every 3 months

Interventions

OnabotulinumtoxinA 100Unit Injection

Initial treatment with the option of repeat injections every 3 months

Intervention Type: DRUG

Other Intervention Names

Botox

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Larry Sirls

Attending Urologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry Sirls, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital-Royal Oak

Locations

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-119

Identifier Type: -

Identifier Source: org_study_id