Chronic Testicular Pain
Conditions
Keywords
Chronic testicular pain, Orchialgia, Botulinum toxin, Botox, Urology
Brief summary
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.
Interventions
DRUGBotox 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.
PROCEDURENormal 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.
Sponsors
Allergan
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of chronic testicular pain (orchialgia)
Exclusion criteria
* Active infection of urinary tract (UTI) * Active infection of the scrotal skin of the affected side * Bilateral orchiectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Pain Score | Baseline and 1 Week Post Injection | 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. |
| Quality of Life Questionnaire Score | 1 week | 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. |
| Units of Analgesics Used for Testicular Pain | 1 week | Change from Baseline in Units of Analgesics Used for Testicular Pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Botox Injection | Saline Injection | Total |
|---|---|---|---|
| Age, Continuous | 75.25 years STANDARD_DEVIATION 8.14 | 56.25 years STANDARD_DEVIATION 12.5 | 65.75 years STANDARD_DEVIATION 14.1 |
| Sex/Gender, Customized Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox Injection | Quality of Life Questionnaire Score | 67.41 units on a scale | Standard Deviation 18.27 |
| Saline Injection | Quality of Life Questionnaire Score | 84.31 units on a scale | Standard Deviation 6.48 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox Injection | Quality of Life Questionnaire Score | 77.04 units on a scale | Standard Deviation 14.29 |
| Saline Injection | Quality of Life Questionnaire Score | 86.59 units on a scale | Standard Deviation 9.23 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox Injection | Quality of Life Questionnaire Score | 67.56 units on a scale | Standard Deviation 30.9 |
| Saline Injection | Quality of Life Questionnaire Score | 84.44 units on a scale | Standard Deviation 11.46 |
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox Injection | Quality of Life Questionnaire Score | 66.48 units on a scale | Standard Deviation 33.4 |
| Saline Injection | Quality of Life Questionnaire Score | 83.66 units on a scale | Standard Deviation 14.94 |
Primary
Units of Analgesics Used for Testicular Pain
Change from Baseline in Units of Analgesics Used for Testicular Pain
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox Injection | Units of Analgesics Used for Testicular Pain | 6 Months Post Procedure | 0 units of analgesics | Standard Deviation 0 |
| Botox Injection | Units of Analgesics Used for Testicular Pain | Baseline | 3.3 units of analgesics | Standard Deviation 5.77 |
| Saline Injection | Units of Analgesics Used for Testicular Pain | Baseline | 2.5 units of analgesics | Standard Deviation 2.5 |
| Saline Injection | Units of Analgesics Used for Testicular Pain | 6 Months Post Procedure | 2.5 units of analgesics | Standard Deviation 2.5 |
Primary
Units of Analgesics Used for Testicular Pain
Change from Baseline in Units of Analgesics Used for Testicular Pain
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox Injection | Units of Analgesics Used for Testicular Pain | Baseline | 3.3 units of analgesics | Standard Deviation 5.77 |
| Botox Injection | Units of Analgesics Used for Testicular Pain | 1 Week Post Procedure | 1.7 units of analgesics | Standard Deviation 2.9 |
| Saline Injection | Units of Analgesics Used for Testicular Pain | Baseline | 2.5 units of analgesics | Standard Deviation 2.5 |
| Saline Injection | Units of Analgesics Used for Testicular Pain | 1 Week Post Procedure | 2.1 units of analgesics | Standard Deviation 2.6 |
Primary
Units of Analgesics Used for Testicular Pain
Change from Baseline in Units of Analgesics Used for Testicular Pain
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox Injection | Units of Analgesics Used for Testicular Pain | Baseline | 3.3 units of analgesics | Standard Deviation 5.77 |
| Botox Injection | Units of Analgesics Used for Testicular Pain | 1 Month Post Procedure | .13 units of analgesics | Standard Deviation 0.23 |
| Saline Injection | Units of Analgesics Used for Testicular Pain | Baseline | 2.5 units of analgesics | Standard Deviation 2.5 |
| Saline Injection | Units of Analgesics Used for Testicular Pain | 1 Month Post Procedure | 2.1 units of analgesics | Standard Deviation 2.6 |
Primary
Units of Analgesics Used for Testicular Pain
Change from Baseline in Units of Analgesics Used for Testicular Pain
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox Injection | Units of Analgesics Used for Testicular Pain | Baseline | 3.3 units of analgesics | Standard Deviation 5.77 |
| Botox Injection | Units of Analgesics Used for Testicular Pain | 3 Months Post Procedure | .67 units of analgesics | Standard Deviation 1.2 |
| Saline Injection | Units of Analgesics Used for Testicular Pain | Baseline | 2.5 units of analgesics | Standard Deviation 2.5 |
| Saline Injection | Units of Analgesics Used for Testicular Pain | 3 Months Post Procedure | 2 units of analgesics | Standard Deviation 2.6 |
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.
Time frame: Baseline and 1 Week Post Injection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox Injection | Visual Analog Scale for Pain Score | Baseline | 59.3 units on a scale | Standard Deviation 17.6 |
| Botox Injection | Visual Analog Scale for Pain Score | 1 Week Post Procedure | 55.0 units on a scale | Standard Deviation 22.9 |
| Saline Injection | Visual Analog Scale for Pain Score | Baseline | 30.3 units on a scale | Standard Deviation 16.4 |
| Saline Injection | Visual Analog Scale for Pain Score | 1 Week Post Procedure | 75.0 units on a scale | Standard Deviation 7.8 |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox Injection | Visual Analog Scale for Pain Score | Baseline | 59.3 units on a scale | Standard Deviation 17.6 |
| Botox Injection | Visual Analog Scale for Pain Score | 6 Months Post Procedure | 78.7 units on a scale | Standard Deviation 12.1 |
| Saline Injection | Visual Analog Scale for Pain Score | Baseline | 30.3 units on a scale | Standard Deviation 16.4 |
| Saline Injection | Visual Analog Scale for Pain Score | 6 Months Post Procedure | 61 units on a scale | Standard Deviation 29.5 |
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox Injection | Visual Analog Scale for Pain Score | 3 Months Post Procedure | 63 units on a scale | Standard Deviation 20.6 |
| Botox Injection | Visual Analog Scale for Pain Score | Baseline | 59.3 units on a scale | Standard Deviation 17.6 |
| Saline Injection | Visual Analog Scale for Pain Score | Baseline | 30.3 units on a scale | Standard Deviation 16.4 |
| Saline Injection | Visual Analog Scale for Pain Score | 3 Months Post Procedure | 84 units on a scale | Standard Deviation 3.5 |
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.
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox Injection | Visual Analog Scale for Pain Score | Baseline | 59.3 units on a scale | Standard Deviation 17.6 |
| Botox Injection | Visual Analog Scale for Pain Score | 1 Month Post Procedure | 56 units on a scale | Standard Deviation 31.5 |
| Saline Injection | Visual Analog Scale for Pain Score | Baseline | 30.3 units on a scale | Standard Deviation 16.4 |
| Saline Injection | Visual Analog Scale for Pain Score | 1 Month Post Procedure | 72.7 units on a scale | Standard Deviation 30 |