Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization
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ClinicalTrials.gov Identifier: NCT03794466 |
Recruitment Status :
Recruiting
First Posted : January 7, 2019
Last Update Posted : November 2, 2022
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Condition or disease |
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Pelvic Congestive Syndrome Pelvic Pain |
Study Type : | Observational |
Estimated Enrollment : | 30 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Quantification of Pain Relief With Gonadal Vein Embolization for Pelvic Congestion Syndrome |
Actual Study Start Date : | May 10, 2019 |
Estimated Primary Completion Date : | September 25, 2023 |
Estimated Study Completion Date : | September 25, 2024 |
- Quantify pain relief using the Pelvic Congestion Symptom Pain Scale after gonadal vein embolization [ Time Frame: Change from baseline (before gonadal vein embolization) to 360 days post-procedure. ]quantify the degree of pain relief in patients undergoing gonadal vein embolization with coils using a survey consisting 4 questions. Answers will be given values 0-4, which higher values are considered to be worse outcomes. One question is "On average, how many days a week do you experience pelvic pain?" Answers would be none (0), 1-2 days a week (1), 3-4 days a week (2), 5-6 days a week (3), and every day of the week (4). Maximum total amount of points will be 16. This is the number of points added together from all 4 questions.
- Predict positive or poor response to gonadal vein embolization treatment [ Time Frame: Change from baseline (before gonadal vein embolization) to 360 days post-procedure. ]Identify clinical or imaging factors that are predictive of a positive response to treatment, or poor response to treatment.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Females |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Female patients 18 years of age or older
- Meet the clinical and imaging criteria for the diagnosis of PCS and have no contraindications to coil embolization of the gonadal veins.
- Patients who are treated with coil embolization of the gonadal veins in the Interventional Radiology division between October 1, 2018 to October 1, 2019.
Exclusion Criteria:
- Patients less than 18 years of age.
- Patients who are found to have an underlying cause of pelvic congestion syndrome unrelated to venous congestion and insufficiency. This includes, but is not limited to, nutcracker syndrome, or a mass resulting in extrinsic compression of the gonadal veins.
- Patients who have received prior surgical therapy for PCS, including bilateral salpingo-oophorectomy (TAH-BSO), gonadal vein resection, or gonadal vein ligation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794466
Contact: Carissa Walter, MPH | 9139457450 | cwalter2@kumc.edu |
United States, Kansas | |
The University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Contact: Carissa Walter, MPH 913-945-7450 cwalter2@kumc.edu | |
Principal Investigator: Adam S Alli, MD | |
Sub-Investigator: Daniel Kirkpatrick, MD | |
Sub-Investigator: Steven Lemons, MD | |
Sub-Investigator: Brandon Custer, MD | |
Sub-Investigator: Philip Johnson, MD | |
Sub-Investigator: Zachary Collins, MD |
Principal Investigator: | Adam S Alli, MD | The University of Kansas Medical Center |
Responsible Party: | University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT03794466 |
Other Study ID Numbers: |
STUDY00143045 |
First Posted: | January 7, 2019 Key Record Dates |
Last Update Posted: | November 2, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
gonadal vein embolization |
Syndrome Pelvic Pain Disease |
Pathologic Processes Pain Neurologic Manifestations |