Chronic Testicular PainPhase 2NCT02058836
Botulinum Toxin for the Management of Chronic Orchialgia
A Phase 2 study testing Botox Injection and Normal saline injection in people with Chronic Testicular Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Chronic Testicular Pain
- What is being tested?
- Botox Injection and Normal saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 18 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic testicular pain (orchialgia)
Who cannot join
- Active infection of urinary tract (UTI)
- Active infection of the scrotal skin of the affected side
- Bilateral orchiectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27103
About this study
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.
- Conditions
- Chronic Testicular Pain
- Being tested
- Botox Injection, Normal saline injection
- Keywords
- Chronic testicular pain, Orchialgia, Botulinum toxin, Botox, Urology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox InjectionDrug
Also called Botox, Botulinum toxin-A
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.
Normal saline injectionProcedure or surgery
Also called 0.9% Sodium Chloride injection, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Botox Injection |
| 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. Receives: Procedure: Normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Units of Analgesics Used for Testicular Pain
Change from Baseline in Units of Analgesics Used for Testicular Pain
Measured: 1 week
Units of Analgesics Used for Testicular Pain
Change from Baseline in Units of Analgesics Used for Testicular Pain
Measured: 1 month
Units of Analgesics Used for Testicular Pain
Change from Baseline in Units of Analgesics Used for Testicular Pain
Measured: 3 months
Units of Analgesics Used for Testicular Pain
Change from Baseline in Units of Analgesics Used for Testicular Pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startNov 2014
- Primary completion18 Oct 2016
- Study completion18 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Testicular PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Ryan P Terlecki, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058836
- Sponsor's protocol ID
- IRB00023188
- Status last verified
- Aug 2018
- First submitted
- 5 Feb 2014
- Last updated
- 5 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin for the Management of Chronic Orchialgia
- ClinicalTrials.gov ID
- NCT02058836
- Acronym / sponsor ID
- IRB00023188
- Conditions
- Chronic Testicular Pain
- Keywords
- Chronic testicular pain, Orchialgia, Botulinum toxin, Botox, Urology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Nov 2014
- Primary completion
- 18 Oct 2016 (actual)
- Study completion
- 18 Oct 2016 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox Injection | Experimental | Drug: Botox InjectionThe 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 | Procedure: Normal saline injectionThe 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic testicular pain (orchialgia)
Key exclusion criteria (3 listed)
- Active infection of urinary tract (UTI)
- Active infection of the scrotal skin of the affected side
- Bilateral orchiectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox InjectionAlso: Botox, Botulinum toxin-AOne-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. | Drug | Botox Injection |
| Normal saline injectionAlso: 0.9% Sodium Chloride injection, Saline injectionOne-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. | Procedure or surgery | Saline Injection |
Primary outcome
Visual Analog Scale for Pain Score
Time frame: 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.
Visual Analog Scale for Pain Score
Time frame: 1 month
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.
Visual Analog Scale for Pain Score
Time frame: 3 months
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.
Visual Analog Scale for Pain Score
Time frame: 6 months
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.
Quality of Life Questionnaire Score
Time frame: 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.
Quality of Life Questionnaire Score
Time frame: 1 month
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.
Quality of Life Questionnaire Score
Time frame: 3 months
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.
Quality of Life Questionnaire Score
Time frame: 6 months
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
Time frame: 1 week
Change from Baseline in Units of Analgesics Used for Testicular Pain
Units of Analgesics Used for Testicular Pain
Time frame: 1 month
Change from Baseline in Units of Analgesics Used for Testicular Pain
Units of Analgesics Used for Testicular Pain
Time frame: 3 months
Change from Baseline in Units of Analgesics Used for Testicular Pain
Units of Analgesics Used for Testicular Pain
Time frame: 6 months
Change from Baseline in Units of Analgesics Used for Testicular Pain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan P Terlecki, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botox Injection and Normal saline injection in people with Chronic Testicular Pain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Pain Score (time frame: Baseline and 1 Week Post Injection). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.