Use of Botox to Treat Scrotal Pain

Study Overview
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Brief Summary
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There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal pain that we found published. We propose a pilot study to use Botox to block the testicular nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using marcaine. Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men would be asked to fill in visual analog scales for pain, a quality of life assessment, a depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.

Official Title
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Use of Botox to Treat Scrotal Pain

Conditions
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Scrotal Pain

Intervention / Treatment
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* Drug: Botox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox<br>Botox: A concentrated dose of Onabotulinum Toxin A of 100 units dissolved in 2 cc of 2% xylocaine for a one-time injection. | Drug: Botox<br> <br> * Other names: Onabotulinum Toxin A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Change in pain is measured by visual analog scales for pain, a quality of life assessment, a depression index (MDI) and Chronic Epididymitis Symptom Index (CESI) before therapy and 1, 3 and 6 months post therapy. In addition, physical examination of the testis and epididymis and sensory testing of the skin of the scrotum and anterior thigh before the therapy and 1, 3 and 6 months post therapy. The sensory testing will be the patients' subjective reporting of the sensation felt with light touch (normal, decreased, increased or painful) and pin prick (decreased, normal or increased) in the skin of the scrotum and anterior thigh of the treated side (the side where the therapy was used) compared to the untreated side (where no therapy was used). | 6 months after entering in trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scrotal pain, Botox