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Lack of enrollment
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 Injection Sites | Experimental | OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder |
|
| 10 Injection Sites | Experimental | OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA 100Unit Injection | Drug | Initial treatment with the option of repeat injections every 3 months |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Sirls, MD | Beaumont Hospital-Royal Oak | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | United States |
Participant data will not be available
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 Injection Sites | OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months |
| FG001 | 10 Injection Sites | OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the initial 6 subjects consented, 1 subject was randomized to the 3 injection site arm and 5 were randomized to the 10 injection site arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 Injection Sites | OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months |
| BG001 | 10 Injection Sites |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Due to the small number of participants statistical analysis was limited. 3 participants completed 3 month diary data. | Posted | Mean | Standard Deviation | Incontinency episodes | 3 months after the initial injection |
|
Adverse event data was collected through study completion, the last study visit was at 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 Injection Sites | OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-void resisdual over 300 cc (300 mL) | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Giordano | William Beaumont Hospital | 248-551-3517 | jennifer.giordano@beaumont.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2020 | Nov 9, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2020 | Oct 4, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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2 arm parallel study with 1 to 1 randomization
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|
| 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 |
| Increase Botox dose |
|
OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder
OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline number of voids | Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of incontinence episodes over a 24 hour period for 3 consecutive days. | Mean | Standard Deviation | Voids |
|
| Baseline number of urge incontinence episodes | Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of urge incontinence episodes over a 24 hour period for 3 consecutive days. | Mean | Standard Deviation | Urge incontinence episodes |
|
| Baseline number of stress incontinence episodes | Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of stress incontinence episodes over a 24 hour period for 3 consecutive days | Mean | Standard Deviation | Stress incontinence episodes |
|
| Baseline 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. | Mean | Standard Deviation | score on a scale |
|
| Baseline 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. | Mean | Standard Deviation | score on a scale |
|
OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months |
|
|
| Secondary | 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. | Due to the small number of participants data analysis was limited. 3 participants completed data at 3 months. | Posted | Mean | Standard Error | score on scale | 3 months after the initial injection |
|
|
|
| Secondary | 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. | Due to small number of participants data analysis was limited. 3 participants had data at 3 months. | Posted | Mean | Standard Deviation | score on a scale | 3 months after the initial injection |
|
|
|
| Secondary | 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. | Due to a small number of participants data analysis was limited. 3 participants completed GRA data at 3 months. | Posted | Count of Participants | Participants | 3 months after the initial injection |
|
|
|
| Secondary | 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. | 6 subjects completed baseline VAS scores. | Posted | Mean | Standard Deviation | score on a scale | After the initial injection |
|
|
|
| Secondary | 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. | Due to small number of participants data analysis was limited. 3 subjects had data available for 3 month timepoints. | Posted | Mean | Standard Error | Episodes | 3 months after the initial injection |
|
|
|
| Secondary | Safety of Bladder Injections | Frequency and severity of study-related adverse events | 3 participants completed the study through the 3 month visit. | Posted | Count of Participants | Participants | At study completion, 3 months after the initial injection |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | 10 Injection Sites | OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months | 0 | 5 | 0 | 5 | 0 | 5 |
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Slightly Improved |
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| No change |
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| Slightly Worse |
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| Moderately Worse |
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| Markedly Worse |
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| Stress incontinence episodes |
|