Phase 2
N=8
Botulinum Toxin for the Management of Chronic Orchialgia
Chronic Testicular Pain
Bottom Line
View on ClinicalTrials.gov: NCT02058836 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Visual Analog Scale for Pain Score — 59.3; 30.3; 55.0; 75.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Botox Injection (Drug); Normal saline injection (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale for Pain Score |
59.3; 30.3; 78.7; 61 | — |
| PRIMARY Visual Analog Scale for Pain Score |
59.3; 30.3; 78.7; 61 | — |
| PRIMARY Visual Analog Scale for Pain Score |
59.3; 30.3; 78.7; 61 | — |
| PRIMARY Visual Analog Scale for Pain Score |
59.3; 30.3; 78.7; 61 | — |
| PRIMARY Quality of Life Questionnaire Score |
77.04; 86.59 | — |
| PRIMARY Quality of Life Questionnaire Score |
77.04; 86.59 | — |
| PRIMARY Quality of Life Questionnaire Score |
77.04; 86.59 | — |
| PRIMARY Quality of Life Questionnaire Score |
77.04; 86.59 | — |
| PRIMARY Units of Analgesics Used for Testicular Pain |
3.3; 2.5; 0; 2.5 | — |
| PRIMARY Units of Analgesics Used for Testicular Pain |
3.3; 2.5; 0; 2.5 | — |
| PRIMARY Units of Analgesics Used for Testicular Pain |
3.3; 2.5; 0; 2.5 | — |
| PRIMARY Units of Analgesics Used for Testicular Pain |
3.3; 2.5; 0; 2.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02058836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.