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OnabotulinumtoxinA Bladder Injection Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523091
Recruitment Status : Terminated (Lack of enrollment)
First Posted : May 14, 2018
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Larry Sirls, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Overactive Bladder Syndrome Urinary Urgency Urinary Incontinence Urinary Frequency/Urgency Urinary Bladder, Overactive Drug: OnabotulinumtoxinA 100Unit Injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arm parallel study with 1 to 1 randomization
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?
Actual Study Start Date : August 8, 2018
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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 Name: 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 Name: Botox




Primary Outcome Measures :
  1. Number of incontinence episodes per day [ Time Frame: Baseline diary compared to 3 month diary after the initial injection ]
    Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of voids and incontinence episodes over a 24 hour period for 3 consecutive days.


Secondary Outcome Measures :
  1. Degree of bladder symptom bother [ Time Frame: Baseline compared to 3 months after the initial injection ]
    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 13-78. The higher the score the greater perceived degree of bladder symptom bother.

  2. Severity of urine leakage [ Time Frame: Baseline compared to 3 months after the initial injection ]
    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. Self-diagnostic item is not scored.

  3. Change in overactive bladder symptoms [ Time Frame: 3 months after the initial injection ]
    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.

  4. Overall patient satisfaction with treatment [ Time Frame: After the initial injection ]
    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 to assess for patient satisfaction, pain, and tolerability of the treatment procedure.

  5. Overall voiding symptoms [ Time Frame: Baseline compared to 3 months after the initial injection ]
    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 and incontinence episodes over a 24 hour period for 3 consecutive days.

  6. Safety of bladder injections [ Time Frame: At study completion, 12 months after the initial injection ]
    Frequency and severity of study-related adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women and men, 18 years of age or older
  • Discontinued antimuscarinics/beta-3 agonists for > 2 weeks prior to study enrollment
  • 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.

Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523091


Locations
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United States, Michigan
Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Larry Sirls, MD Beaumont Hospital-Royal Oak
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Responsible Party: Larry Sirls, Attending Urologist, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT03523091    
Other Study ID Numbers: 2018-119
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data will not be available

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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
Keywords provided by Larry Sirls, William Beaumont Hospitals:
OnabotulinumtoxinA
Bladder Injections
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Bladder Diseases
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents