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Evaluation of Botox Treatment on Chronical Scrotal Pain

NCT05112081 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-04-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Nicolai Skov Schiellerup

    lead OTHER

Principal Investigators

  • Mads H Poulsen, MD, PhD · Assistant professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05112081 on ClinicalTrials.gov