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Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain

NCT02249234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-03-11

No results posted yet for this study

Summary

There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published.

We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug.

The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo.

We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.

Conditions

  • Scrotal Pain

Interventions

DRUG

Botox

DRUG

Placebo

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Keith Jarvi, MD · Mount Sinai Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT02249234 on ClinicalTrials.gov