Evaluation of Botox Treatment on Chronical Scrotal Pain

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicolai Skov Schiellerup
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

1. Age of 18 - 70 years

2. Unilateral or bilateral scrotal pain > 3 months

3. No other identifiable cause of pain

4. Insufficient effect of conservative treatment

5. A positive effect of local anesthesia spermatic cord block

Exclusion Criteria:

1. Inability to provide informed consent

2. Interest in trying to conceive with partner in the following 6 months

3. Local infection near the proposed injection site

4. History with an allergic reaction to BTX and / or human serum albumin

5. History of motor neuron disease or hemostatic disorder

6. Active urogenital cancer

7. Current use of botox injections which would result in a total dose of botox higher than 300 IE in the span of 3 months