OnabotulinumtoxinA Bladder Injection Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Overactive Bladder; Urinary Bladder, Overactive; Urinary Incontinence; Overactive Bladder Syndrome; Urinary Urgency; Urinary Frequency/Urgency
• Intervention / Treatment: Drug: OnabotulinumtoxinA 100Unit Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital-Royal Oak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Larry Sirls, MD, Beaumont Hospital-Royal Oak

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: OnabotulinumtoxinA; Bladder Injections
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2018-119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Participant data will not be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes