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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose of this research study is to determine if Botox injections will provide relief from chronic testicular pain. In the study, the spermatic cord of particpants will be injected with either Botox or a placebo of saline. Botox is currently used to treat other urological conditions like overactive bladder and lower urinary tract problems. For these conditions, Botox works by relaxing muscles in the affected areas. The investigators believe that Botox will act similarly in the treatment chronic testicular pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox Injection | Experimental | The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. |
|
| Saline Injection | Placebo Comparator | The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox Injection | Drug | One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for Pain Score | Visual Analog Scale for Pain Score (VAS). It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes. | Baseline and 1 Week Post Injection |
| Visual Analog Scale for Pain Score | Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes. | 1 month |
| Visual Analog Scale for Pain Score | Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan P Terlecki, MD | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botox Injection | The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. |
| FG001 | Saline Injection | The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botox Injection | The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. |
| 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 | Visual Analog Scale for Pain Score | Visual Analog Scale for Pain Score (VAS). It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week Post Injection |
|
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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 Injection | The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Terlecki | Wake Forest University Health Sciences | 336-716-2011 | rterlecki@wakehealth.edu |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Normal saline injection | Procedure | One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. |
|
|
| Visual Analog Scale for Pain Score | Visual Analog Scale for Pain score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes. | 6 months |
| Quality of Life Questionnaire Score | Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes. | 1 week |
| Quality of Life Questionnaire Score | Quality of Life Questionnaire Score. To assess the QOL, a SF-36 was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The score range is 0-100 and higher scores denotes better outcomes. | 1 month |
| Quality of Life Questionnaire Score | Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes. | 3 months |
| Quality of Life Questionnaire Score | Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes. | 6 months |
| Units of Analgesics Used for Testicular Pain | Change from Baseline in Units of Analgesics Used for Testicular Pain | 1 week |
| Units of Analgesics Used for Testicular Pain | Change from Baseline in Units of Analgesics Used for Testicular Pain | 1 month |
| Units of Analgesics Used for Testicular Pain | Change from Baseline in Units of Analgesics Used for Testicular Pain | 3 months |
| Units of Analgesics Used for Testicular Pain | Change from Baseline in Units of Analgesics Used for Testicular Pain | 6 months |
| BG001 | Saline Injection | The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| OG001 | Saline Injection | The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. |
|
|
| Primary | Visual Analog Scale for Pain Score | Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
|
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| Primary | Visual Analog Scale for Pain Score | Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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|
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| Primary | Visual Analog Scale for Pain Score | Visual Analog Scale for Pain score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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|
|
| Primary | Quality of Life Questionnaire Score | Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
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|
|
| Primary | Quality of Life Questionnaire Score | Quality of Life Questionnaire Score. To assess the QOL, a SF-36 was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The score range is 0-100 and higher scores denotes better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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|
|
| Primary | Quality of Life Questionnaire Score | Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Primary | Quality of Life Questionnaire Score | Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Primary | Units of Analgesics Used for Testicular Pain | Change from Baseline in Units of Analgesics Used for Testicular Pain | Posted | Mean | Standard Deviation | units of analgesics | 1 week |
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| Primary | Units of Analgesics Used for Testicular Pain | Change from Baseline in Units of Analgesics Used for Testicular Pain | Posted | Mean | Standard Deviation | units of analgesics | 1 month |
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| Primary | Units of Analgesics Used for Testicular Pain | Change from Baseline in Units of Analgesics Used for Testicular Pain | Posted | Mean | Standard Deviation | units of analgesics | 3 months |
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| Primary | Units of Analgesics Used for Testicular Pain | Change from Baseline in Units of Analgesics Used for Testicular Pain | Posted | Mean | Standard Deviation | units of analgesics | 6 months |
|
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|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Saline Injection | The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. | 0 | 4 | 0 | 4 |
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| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |