Botulinum Toxin for the Management of Chronic Orchialgia

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Chronic Testicular Pain

Treatments: Drug: Botox Injection; Procedure: Normal saline injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02058836

IRB00023188

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Botox Injection

Experimental group

Description:

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.

Treatment:

Drug: Botox Injection

Saline Injection

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Normal saline injection