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The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.
A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | Botox |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | Injected |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incontinent Episodes Per Day | The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point. | week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Incontinence Pads Used Per Day | The number of incontinence pads used per day per day was recorded by each participant in a diary. | week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael K Flynn, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Davis | Sacramento | California | 95817 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15538257 | Result | Flynn MK, Webster GD, Amundsen CL. The effect of botulinum-A toxin on patients with severe urge urinary incontinence. J Urol. 2004 Dec;172(6 Pt 1):2316-20. doi: 10.1097/01.ju.0000143889.00681.3f. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | 6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site. |
| FG001 | Botox Group | Botox (BTX) was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | 6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site. |
| BG001 | Botox Group | BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incontinent Episodes Per Day | The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point. | Posted | Geometric Least Squares Mean | Standard Error | incontinence episodes per day | week 13 |
|
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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 | Placebo Group | 6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Division of Urogynecology | University of Rochester | 585-273-3232 | amy_keller@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| 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 |
Injected |
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Number of Incontinence Pads Used Per Day | The number of incontinence pads used per day per day was recorded by each participant in a diary. | Posted | Geometric Least Squares Mean | Standard Error | pads per day | week 13 |
|
|
|
|
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Botox Group | BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site. | 0 | 20 | 11 | 20 |
| post void retention volumes > 200cc | 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 |