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This is a prospective, randomized, double-blind study comparing intravesical injection of BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following treatment groups:
Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0), subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and 270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.
Subjects demonstrating an insufficient response to treatment may receive an open-label injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will re-commence Follow-up Visits and be followed for an additional 270 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox | Active Comparator | 200U onabotulinumtoxinA (botox) |
|
| Placebo | Placebo Comparator | 200U Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | Botox injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Frequency | This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270 | From Baseline to Day 270 |
| Urgency | This measured the degree of urinary urgency using a 3-day voiding diary. Patients were assessed for the number of urgency episodes they had by answering yes or no. | From Baseline to Day 270 |
| Quality of Life (QoL) | Quality of Life (QoL) is from the ICIQ-QAB (international Consultation of Incontinence Overactive Bladder) Questionnaire. It is scored 25-160 and those with higher scores have higher impact on quality of life. | From Baseline to Day 270 |
| International Consultation on Incontinence Questionnaire (ICIQ) | ICIQ is a brief validated instrument that is comprehensive for the assessment of incontinence and measures frequency, severity and impact on quality of life. There are a total of 23 items. The overall score ranges from 1-84 with greater values indicating increased symptom severity. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. | From Baseline to Day 270 |
| Postvoid Residual Volume (PVR) | Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition. | From Baseline to Day 270 |
| Maximum Flow Rate (Qmax) | Qmax is the the maximum recorded flow rate | From Baseline to Day 270 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Te | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
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The total number of participants recruited and enrolled was 30. A total of 28 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Botox | 200U onabotulinumtoxinA (botox) Botox: Botox injection |
| FG001 | Placebo | 200U Saline Placebo: Placebo injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botox | 200U onabotulinumtoxinA (botox) Botox: Botox injection |
| BG001 | Placebo | 200U Saline Placebo: Placebo injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Urinary Frequency | This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270 | Posted | Median | Inter-Quartile Range | urinations | From Baseline to Day 270 |
|
|
Adverse Events were collected over 1 year
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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 | Botox | Number of adverse events that occurred in the botox arm | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexis Te | Weill Cornell Medical College | 646-962-4811 | aet2005@med.cornell.edu |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| 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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| Drug |
Placebo injection |
|
| International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic) | From Baseline to Day 270 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Full Range | kg/m^2 |
|
| Baseline International Prostate Symptom Score | International Prostate Symptom Score (IPSS) is a 7 point scale used to screen, track and manage symptoms associated with BPH. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). | Median | Inter-Quartile Range | units on a scale |
|
| Baseline maximum flow rate (Qmax) | Maximum flow rate (Qmax) is the the maximum recorded flow rate | Mean | Standard Deviation | mL/s |
|
| Baseline Voided Volume | Voided volume is the amount of urine output during a micturition. | Mean | Standard Deviation | mL |
|
| Baseline postvoid residual volume (PVR) | Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition. | Mean | Standard Deviation | mL |
|
| Baseline Voiding frequency | This is the frequency of micturitions during a 24-hour period. | Median | Inter-Quartile Range | times voided |
|
| Type of Procedure: TURP or Laser | Transurethral resection of the prostate (TURP) involves resecting the prostatic tissue, while a laser procedure involves vaporizing the tissue using a laser. | Number | participants |
|
|
|
| Primary | Urgency | This measured the degree of urinary urgency using a 3-day voiding diary. Patients were assessed for the number of urgency episodes they had by answering yes or no. | Posted | Median | Inter-Quartile Range | episodes | From Baseline to Day 270 |
|
|
|
| Primary | Quality of Life (QoL) | Quality of Life (QoL) is from the ICIQ-QAB (international Consultation of Incontinence Overactive Bladder) Questionnaire. It is scored 25-160 and those with higher scores have higher impact on quality of life. | Posted | Median | Inter-Quartile Range | scores on a scale | From Baseline to Day 270 |
|
|
|
| Primary | International Consultation on Incontinence Questionnaire (ICIQ) | ICIQ is a brief validated instrument that is comprehensive for the assessment of incontinence and measures frequency, severity and impact on quality of life. There are a total of 23 items. The overall score ranges from 1-84 with greater values indicating increased symptom severity. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. | Posted | Median | Inter-Quartile Range | units on a scale | From Baseline to Day 270 |
|
|
|
| Primary | Postvoid Residual Volume (PVR) | Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition. | Posted | Mean | Standard Deviation | mL | From Baseline to Day 270 |
|
|
|
| Primary | Maximum Flow Rate (Qmax) | Qmax is the the maximum recorded flow rate | Posted | Mean | Standard Deviation | mL/s | From Baseline to Day 270 |
|
|
|
| Primary | International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic) | Posted | Median | Inter-Quartile Range | units on a scale | From Baseline to Day 270 |
|
|
|
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | Placebo | Number of adverse events that occurred in the placebo arm | 0 | 13 | 0 | 13 | 0 | 13 |
| Acute Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| 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 |
| 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 |
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| Day 90 |
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| Day 180 |
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| Day 270 |
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