Botulinum Toxin for the Management of Chronic Orchialgia

Phase 2

Completed

• Conditions: Chronic Testicular Pain
• Interventions: Drug: Botox Injection; Procedure: Normal saline injection

• Registration Number: NCT02058836
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-10
• Study Start: 2014-11
• Primary Completion: 2016-10-18
• Study Completion: 2016-10-18
• Results First Submitted: 2017-11-22
• Results First Submitted QC: 2017-12-22
• Results First Posted: 2018-01-23
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Clinical diagnosis of chronic testicular pain (orchialgia)

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Exclusion Criteria

• Active infection of urinary tract (UTI)
• Active infection of the scrotal skin of the affected side
• Bilateral orchiectomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botox Injection	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.
Saline Injection	Normal 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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale for Pain Score	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	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	6 months	Change from Baseline in Units of Analgesics Used for Testicular Pain

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States