Health TrialsbyHealthPanel

Evaluation of Botox Treatment on Chronical Scrotal Pain

ConditionsScrotum DiseaseChronic Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-70
SponsorNicolai Skov Schiellerup

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18 - 70 years

Unilateral or bilateral scrotal pain > 3 months

No other identifiable cause of pain

Insufficient effect of conservative treatment

Disqualifiers

Inability to provide informed consent

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

Local infection near the proposed injection site

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Botulinum toxin type A

    Drug

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

  • Sterile saline

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Botox injectionsExperimental treatment 1 intervention
Group B: Sterile saline injectionsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Effect on pain 3 months after treatment

Pain is evaluated on a Visual Analog Scale (VAS) from 0-10, where 0 is no pain and 10 is the maximal pain a patient can report. VAS prior to the treatment is compared to VAS 3 months after treatment.

Time frame
3 months

Secondary outcomes

1

Duration of effect

Pain is evaluated on a Visual Analog Scale (VAS) from 0-10, where 0 is no pain and 10 is the maximal pain a patient can report. Patients will evaluate pain by VAS after 1, 2, 3, 4, 8 and 12 weeks

Time frame
3 months
2

Changes in patient reported Quality of Life

Quality-of-life (EQ-5D-5L) Questionnaire containing 5 dimensions with a score scale from 0 - 5. A higher score correlates to a more negative impact on the patients life. Questionnaire will be repeated after 1, 2, 3, 4, 8 and 12 weeks

Time frame
3 months
3

Changes in patient reported Quality of Life

Chronic Prostatitis Symptom Index (NIH-CPSI) The NIH-CPSI has a total score range from 0 to 43, and it includes three subscales addressing pain (score range 0-21). A higher score correlates to a more negative impact on the patients life. Questionnaire will be repeated after 1, 2, 3, 4, 8 and 12 weeks

Time frame
3 months
4

Changes in patient reported Quality of Life

ICD-10 depression questionnaire (MDI) Patients can score 0 - 5 in multiple questions. A higher score signifies deeper depression. Questionnaire will be repeated after 1, 2, 3, 4, 8 and 12 weeks

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicolai Skov Schiellerup

Lead sponsor

Odense University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: