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

## TL;DR

This study will test if Botox injections can reduce chronic scrotal pain and improve quality of life in male patients.

## Contribution

The study introduces a randomized, double-blinded trial to evaluate Botox for chronic scrotal pain, a condition with limited treatment options.

## Key findings

- The primary outcome will assess pain reduction using a visual analogue score at 3 months.
- Secondary outcomes include the duration of Botox effects and changes in quality of life and depression symptoms.
- Patients in the control group will have the option to cross over after the initial 12-week study period.

## Abstract

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.

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

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.

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.