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NOT YET RECRUITING
NCT05112081
PHASE4

Evaluation of Botox Treatment on Chronical Scrotal Pain

Sponsor: Nicolai Skov Schiellerup

View on ClinicalTrials.gov

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.

Official title: Evaluation of Botox Treatment in Patients With Chronic Scrotal Pain: a Randomized Double Blinded Control Trial

Key Details

Gender

MALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-06-01

Completion Date

2026-06-30

Last Updated

2022-04-20

Healthy Volunteers

No

Interventions

DRUG

Botulinum toxin type A

The group will receive a solution of 100 units BTX with 10 ml sterile saline close to the superficial inguinal ring.

OTHER

Sterile saline

The group will receive a solution of 10 ml sterile saline close to the superficial inguinal ring.

Locations (1)

Odense University Hospital

Odense C, Fyn, Denmark