CT-guided Pudendal Nerve Cryoneurolysis for Palliation of Malignancy-induced Pelvic Pain

We want to study if a new treatment called "CT-guided bilateral pudendal nerve cryoneurolysis" can help people with severe and long-lasting pain in the pelvic area caused by cancer. We will closely follow and observe patients who undergo this treatment to see if it works well, what results it gives, and if there are any problems or side effects. "Percutaneous image-guided cryoneurolysis" involves using very cold temperatures to treat the nerves causing the pain. This method has been found to provide longer pain relief compared to injections or catheters, and it also has a lower risk of certain complications.

We are conducting a study to assess the effectiveness of two different treatments for severe and persistent pelvic pain caused by cancer. The first treatment, known as "CT-guided bilateral pudendal nerve cryoneurolysis," involves using advanced imaging technology to precisely target and freeze the pudendal nerves, which are responsible for transmitting pain signals. By closely monitoring patients who receive this treatment, we aim to evaluate its efficacy, outcomes, and potential side effects.

On the other hand, the second treatment approach, referred to as "Percutaneous image-guided cryoneurolysis," focuses on using extremely cold temperatures to alleviate pain originating from the pudendal nerves. This method has demonstrated extended pain relief compared to alternatives like injections or catheters. Additionally, it presents a lower risk of certain complications. Through our study, we seek to gain insights into the effectiveness and safety of both treatment methods, enhancing our understanding of how to address the challenging issue of cancer-related pelvic pain.

The study will enroll patients who are dealing with severe and persistent pelvic pain from cancer. All patients will undergo the CT-guided bilateral pudendal nerve cryoneurolysis first type of treatment and if it is not effective in relieving the pain, they will be offered to undergo the second treatment called Percutaneous image-guided cryoneurolysis.

Both of these treatments are done as standard of care. This research study will not alter standard of care. Subjects will only be enrolled into this study if they are already undergoing CT-guided bilateral pudendal nerve cryoneurolysis followed up with Percutaneous image-guided cryoneurolysis, as needed. This is a prospective study of these two treatments following patient outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignancy-induced Pelvic Pain
• Intervention / Treatment: Drug: CT-guided Pudendal Nerve Cryoneurolysis; Drug: Percutaneous image-guided cryoneurolysis

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Shamar J Young, MD; Phone Number: 5206261957; Email: shamar@radiology.arizona.edu
• Study Contact Backup: Name: Melissa Ruiz; Phone Number: 520-621-8250; Email: mruiz@radiology.arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724-5067
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Interventional Radiology Oncology clinic

Description

Inclusion Criteria:

Those already scheduled for a CT-guided bilateral pudendal nerve cryoneurolysis as standard of care Age ≥18 years old Active or history of pelvic cancer malignancy Poor pelvic pain control with current therapy (pain from cancer malignancy) Pain in distribution of the pudendal (genital) nerves from cancer malignancy

Exclusion Criteria:

Pain in distribution of the pudendal nerves from nonmalignant etiology Patients with pain from other medical conditions besides cancer/cancer malignancy will not be included (cancer-related pain from cancer malignancy in the genital region is considered).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cohort 1

Drug: CT-guided Pudendal Nerve Cryoneurolysis; CT-guided bilateral pudendal nerve cryoneurolysis involves using advanced imaging technology to precisely target and freeze the pudendal nerves, which are responsible for transmitting pain signals.; Drug: Percutaneous image-guided cryoneurolysis; Percutaneous image-guided cryoneurolysis focuses on using extremely cold temperatures to alleviate pain originating from the pudendal nerves. This method has demonstrated extended pain relief compared to alternatives like injections or catheters. Additionally, it presents a lower risk of certain complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale (VAS) Improvement	12 weeks

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Shamar J Young, MD, University of Arizona - Department of Medical Imaging

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neoplasms; Pelvic Pain
• Other Study ID Numbers: STUDY00002955

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No