Evaluation of Botox Treatment on Chronical Scrotal Pain

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-70
SponsorNicolai Skov Schiellerup

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

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nicolai Skov Schiellerup

Lead sponsor

Odense University Hospital

Sponsor institution