Scrotal PainPhase 2ROBOTNCT02249234
Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain
A Phase 2 study testing Botox in people with Scrotal Pain, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published. We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Scrotal Pain
- What is being tested?
- Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Have nociceptive scrotal pain,
- Have no identifiable, reversible causes for the scrotal pain
- Have failed standard medical therapy
- Have responded temporarily to cord blocks
Who cannot join
- Are interested in trying to conceive with their partners in the next 6 months,
- Have any local infection near the site of the injections,
- Have had an allergic reaction to Botox in the past,
- Are unable to provide informed consent
- Have a history of motor neuron disease or neurogenic bladder
- Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners
Trial locations and contacts
1 site in 1 country.
About this study
There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published.
We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug.
The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo.
We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.
- Conditions
- Scrotal Pain
- Being tested
- Botox, Placebo
- Keywords
- Scrotal pain, Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Also called OnabotulinumtoxinA
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Botox | Experimental | Botox 200 units reconstituted in 10ml of normal saline for a one-time injection Receives: Drug: Botox |
| Saline | Placebo comparator | Saline 10ml of normal saline for a one-time injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the visual analog scales for pain
A measure of the change in the visual analog scales for pain.
Measured: 6 months after entering in trial
Secondary outcomes (1)
Reduction in scrotal pain
It will be assessed by the Chronic Epididymitis Symptom Index score.
Measured: 6 months after entering in trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scrotal PainStudies of the same condition, open and under way.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Jarvi, MD, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249234
- Sponsor's protocol ID
- CAN-BTX-RCT
- Acronym
- ROBOT
- Status last verified
- Mar 2019
- First submitted
- 28 Aug 2014
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain
- ClinicalTrials.gov ID
- NCT02249234
- Acronym / sponsor ID
- ROBOT / CAN-BTX-RCT
- Conditions
- Scrotal Pain
- Keywords
- Scrotal pain, Botox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published.
We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug.
The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo.
We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal 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 | Experimental | Drug: BotoxBotox 200 units reconstituted in 10ml of normal saline for a one-time injection |
| Saline | Placebo comparator | Drug: PlaceboSaline 10ml of normal saline for a one-time injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65
- Have nociceptive scrotal pain,
- Have no identifiable, reversible causes for the scrotal pain
- Have failed standard medical therapy
- Have responded temporarily to cord blocks
Key exclusion criteria (6 listed)
- Are interested in trying to conceive with their partners in the next 6 months,
- Have any local infection near the site of the injections,
- Have had an allergic reaction to Botox in the past,
- Are unable to provide informed consent
- Have a history of motor neuron disease or neurogenic bladder
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 |
|---|---|---|
| BotoxAlso: OnabotulinumtoxinA | Drug | Botox |
| Placebo | Drug | Saline |
Primary outcome
Reduction in the visual analog scales for pain
Time frame: 6 months after entering in trial
A measure of the change in the visual analog scales for pain.
1 secondary outcome
Reduction in scrotal pain
Time frame: 6 months after entering in trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Related trials for Scrotal Pain
RecruitingObservational study
Evaluation of the Diagnostic Performance of the Testicular Workup for Ischemia and Suspected Torsion (TWIST) Score for Assessing the Risk of Testicular Torsion in Adult Patients Presenting to the Emergency Department With Scrotal Pain - A Prospective Observational Study
Testicular Torsion, Acute Scrotum
RecruitingPhase 2
Sustained Release Lidocaine for the Treatment of Postoperative Pain
Postoperative Pain, Postsurgical Pain
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.
Keith Jarvi, MD principal investigator
Mount Sinai Hospital, Canada
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 in people with Scrotal Pain, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 5 inclusion and 6 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 11 Mar 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in the visual analog scales for pain (time frame: 6 months after entering in trial). 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 11 Mar 2019.