Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Allergan | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A in interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®, is a medication that comes from the bacteria Clostridium botulinum. It works by blocking the release of the neurotransmitter acetylcholine(a chemical messenger that carries signals between nerve cells and other cells in the body). Blocking that neurotransmitter results in decreased muscle activity.
The purpose of this study is to evaluate the efficacy of intravesicular Onabotulinumtoxin A injections for the treatment of interstitial cystitis (IC). Specifically, we hypothesize that trigonal Onabotulinumtoxin A injections is an effective treatment for IC and will result in more subjective and objective symptom relief than posterior wall Onabotulinumtoxin A injections.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox upper aspect trigone | Experimental | Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder. |
|
| botox periphery of trigone | Active Comparator | Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onabotulinumtoxin A | Drug | 100 units of botox spread out among 10 separate injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes. | The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes. | 30 and 90 days post treatment |
| The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire | The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes. | 30 and 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Performance in Uroflowmetry. | Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes. | 30 days and 90 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals. | 30 days and 90 days post treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert J Evans, M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27103 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Botox Upper Aspect Trigone | Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder. Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. |
| FG001 | Botox Periphery of Trigone | Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone). Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Botox Upper Aspect Trigone | Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder. Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. |
| 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 | The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes. | The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes. | One participant was lost to follow-up in the experimental group and no data was collected at 30 days on one participant in the control group. | Posted | Mean | Standard Deviation | units on a scale | 30 and 90 days post treatment |
|
baseline, up to 4 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botox Upper Aspect Trigone | Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder. Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Painful Voiding | Renal and urinary disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Evans | Wake Forest University Health Sciences | 336-713-0320 | revans@wakehealth.edu |
Not provided
| 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 | Aug 15, 2014 | Mar 19, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| injections upper aspect of trigone of urinary bladder | Procedure | We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. |
|
| injections on posterior bladder wall excluding the trigone | Procedure | We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. |
|
| BG001 | Botox Periphery of Trigone | Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone). Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Botox Periphery of Trigone | Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone). Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. |
|
|
| Primary | The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire | The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes. | One participant from the experimental group was lost to follow-up. Data was not collected at 30 days for bother and symptom for one participant in the control group. | Posted | Mean | Standard Deviation | units on a scale | 30 and 90 days post-treatment |
|
|
|
| Secondary | Change in Patient Performance in Uroflowmetry. | Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes. | No data was collected for two participants in the experimental group and one participant in the control group at 30 days. No data was collected for one participant in the experimental group at 90 days. | Posted | Mean | Standard Deviation | ml/s | 30 days and 90 days post treatment |
|
|
|
| Other Pre-specified | Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals. | Data was not collected on one participant in the experimental group at 30 and 90 days post treatment. Data was not collected on two individuals at 30 days post treatment in the control group. | Posted | Mean | Standard Deviation | mL | 30 days and 90 days post treatment |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 4 |
| 13 |
| EG001 | Botox Periphery of Trigone | Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone). Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder. | 0 | 14 | 0 | 14 | 7 | 14 |
| Urethral Edema | Renal and urinary disorders | Non-systematic Assessment |
|
| Urgency | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Retention | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| 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 |
| Bother @ 30 days |
|
|
| Symptoms @ 90 days |
|
|
| Bother @ 90 days |
|
|
| @ 90 days |
|
|
| @ 90 days |
|
|