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

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

NCT ID: NCT06110065

Condition: Malignancy-induced Pelvic Pain

Conditions: Official terms:
Neoplasms
Pelvic Pain

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: CT-guided Pudendal Nerve Cryoneurolysis
Description: 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.
Arm group label: Cohort 1

Intervention type: Drug
Intervention name: Percutaneous image-guided cryoneurolysis
Description: 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.
Arm group label: Cohort 1

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.

Criteria for eligibility:

Study pop:
Interventional Radiology Oncology clinic

Sampling method: Probability Sample
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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Arizona

Address:
City: Tucson
Zip: 85724-5067
Country: United States

Start date: November 2023

Completion date: November 2027

Lead sponsor:
Agency: University of Arizona
Agency class: Other

Source: University of Arizona

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06110065