Evaluation of Botox treatment in patients with chronic scrotal pain: Protocol for a randomized double-blinded control trial.

BACKGROUND

Chronic scrotal pain is a common condition with a prevalence of 2.5-4.8% in male outpatients. Up to 40% of these patients report depressive symptoms and many feel isolated. Minimal invasive treatment is lacking, while spermatic cord injections of Botox® (BTX) have been proposed to offer long-term pain relief.

STUDY DESIGN

This research protocol comprises a prospective multicentre, randomized, double-blinded clinical trial drawing patients from other urological departments in the region of Southern Denmark.

END POINTS

The primary end point will be reduction in pain evaluated by visual analogue score for pain at 3 months. Secondary end point will be length of effect of BTX injections along with changes in quality of life.

PATIENTS AND METHODS

The study will include 50 patients for randomization to either spermatic cord block with 100 IE BTX or sterile saline. All patients will prior to randomization undergo physical examination and will be asked to fulfil multiple questionnaires regarding pain and impact in daily life, that is, (1) visual analogue score for pain, (2) quality of life (EQ-5D-5L), (3) Chronic Prostatitis Symptom Index (NIH-CPSI), (4) ICD-10 depression questionnaire (MDI), (5) Likert global assessment scale, and (6) International Index of Erectile Function questionnaire. Physical examination and fulfilment of the questionnaires will be repeated multiple times throughout the study period of 12 weeks. After this time point, patients will be unblinded, and the control arm will be given the opportunity of cross-over.