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OnabotulinumtoxinA Bladder Injection Study

Primary Purpose

Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
OnabotulinumtoxinA 100Unit Injection
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring OnabotulinumtoxinA, Bladder Injections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beaumont Hospital-Royal Oak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3 Injection Sites

10 Injection Sites

Arm Description

OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder

OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Safety of Bladder Injections
Frequency and severity of study-related adverse events

Full Information

First Posted
May 1, 2018
Last Updated
January 14, 2022
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03523091
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency, Urinary Incontinence, Urinary Frequency/Urgency, Urinary Bladder, Overactive
Keywords
OnabotulinumtoxinA, Bladder Injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 arm parallel study with 1 to 1 randomization
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 Injection Sites
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder
Arm Title
10 Injection Sites
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder
Intervention Type
Drug
Intervention Name(s)
OnabotulinumtoxinA 100Unit Injection
Other Intervention Name(s)
Botox
Intervention Description
Initial treatment with the option of repeat injections every 3 months
Primary Outcome Measure Information:
Title
Number of Incontinence Episodes Per Day
Description
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.
Time Frame
3 months after the initial injection
Secondary Outcome Measure Information:
Title
Degree of Bladder Symptom Bother
Description
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.
Time Frame
3 months after the initial injection
Title
Severity of Urine Leakage
Description
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.
Time Frame
3 months after the initial injection
Title
Change in Overactive Bladder Symptoms
Description
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.
Time Frame
3 months after the initial injection
Title
Overall Patient Pain Tolerability With Treatment
Description
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.
Time Frame
After the initial injection
Title
Overall Voiding Symptoms at 3 Months
Description
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.
Time Frame
3 months after the initial injection
Title
Safety of Bladder Injections
Description
Frequency and severity of study-related adverse events
Time Frame
At study completion, 3 months after the initial injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Sirls, MD
Organizational Affiliation
Beaumont Hospital-Royal Oak
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will not be available

Learn more about this trial

OnabotulinumtoxinA Bladder Injection Study

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