Botulinum Toxin for the Management of Chronic Orchialgia

NCT ID: NCT02058836

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-10-18

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.

Conditions

Chronic Testicular Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Botox Injection

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Normal saline injection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

Botox; Botulinum toxin-A; 0.9% Sodium Chloride injection; Saline injection

Eligibility Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan P Terlecki, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00023188

Identifier Type: -

Identifier Source: org_study_id