About this trial
The aim of the study is to evaluate the effect of botox injections at the spermatic cord in patients with chronical scrotal pain.
A lot of patients experiences depressive symptoms and a lot feel isolated. The etiology if not fully understood and the condition poses a challenge for physicians.
The is no efficient minimal invasive treatment for these patients, and in severe cases patients are having there testicle removed.
By inject botox around the spermatic cord the investigators hope to relieve some of the pain in these patients and offer patients a new minimal invasive treatment.
The investigators aim to include 50 patients in this study, There will be randomised 1:1 to either the intervention arm (Botox) or control arm (sterile saline). Both patients and physicians will be blinded to the treatment.
Patients will undergo a thorough physical examination and will be asked to fill out questionaries to asses their quality of life.
After inclusion, patients will be followed closely for three months with physical examination and questionnaires.
After three months, patients in the control arm will have the opportunity to cross over to the intervention arm.
Data will be reported continuously.
Eligibility criteria
Qualifiers
Age of 18 - 70 years
Unilateral or bilateral scrotal pain > 3 months
No other identifiable cause of pain
Insufficient effect of conservative treatment
Disqualifiers
Inability to provide informed consent
Interest in trying to conceive with partner in the following 6 months
Local infection near the proposed injection site
History with an allergic reaction to BTX and / or human serum albumin
Trial design
Treatments tested in this trial
- Botulinum toxin type A
- Sterile saline
Treatment groups
Sponsors and collaborators
Nicolai Skov Schiellerup
Lead sponsor
Odense University Hospital
Sponsor institution