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

NCT ID: NCT06110065

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2027-11-30

Brief Summary

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.

Conditions

Malignancy-induced Pelvic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

CT-guided Pudendal Nerve Cryoneurolysis

Intervention Type: DRUG

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.

Percutaneous image-guided cryoneurolysis

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shamar J Young, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona - Department of Medical Imaging

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Central Contacts

Shamar J Young, MD

Role: CONTACT

Phone: 5206261957

Email: shamar@radiology.arizona.edu

Melissa Ruiz

Role: CONTACT

Phone: 520-621-8250

Email: mruiz@radiology.arizona.edu

Other Identifiers

STUDY00002955

Identifier Type: -

Identifier Source: org_study_id