CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Botox Injection +1 moredrug
Likely dose
Botox Injection 100 Unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02058836
NCT02058836Phase 2Completed

Botulinum Toxin for the Management of Chronic Orchialgia

Wake Forest University Health Sciences·interventional·Posted Feb 10, 2014·Updated Sep 5, 2018

In Brief

A Phase 2 clinical trial evaluating Botox Injection and Normal saline injection for Chronic Testicular Pain. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2014
Enrollment StartNov 1, 2014
Primary CompletionOct 18, 2016
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.4 years ago

Interventions

Botox Injectiondrug

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.

Normal saline injectionprocedure

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.