Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
February 7, 2019 updated by: St. Olavs Hospital
Results of recent systematic reviews suggest favorable results of embolization for the treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for several outcomes, including pain reduction, overall patient satisfaction, and technical feasibility. Reported complication rates appears relatively low.
Pelvic vein embolization is a relatively new technology and the results may provide background for an evidence based decision to offer embolization of pelvic varicosities for women with PCS in Norway.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway
- St Olavs Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pelvic pain (lasting for more than 6 months)
- Symptoms of PCS - deterioration of pain when standing and improvement in supine position (with or without dyspareunia or dysmenorrhea).
- Confirmed pelvic varicosities by magnetic resonance examination.
- Signed, written and informed consent
Exclusion Criteria:
- Inability to communicate in Norwegian
- Known endometriosis
- Uterine myoma, uterine anomalies, or cancer
- Postmenopausal
- not having been pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pelvic vein embolization
female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital, Trondheim, Norway
|
Embolization of pelvic vein varicosities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
chronic pelvic pain
Time Frame: 3 months
|
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
|
3 months
|
|
chronic pelvic pain
Time Frame: 6 months
|
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
|
6 months
|
|
chronic pelvic pain
Time Frame: 1 year
|
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health related quality of life (HRQOL)
Time Frame: 3 months
|
based on the SF-8 and mental health measurements based on the 5-mental health inventory
|
3 months
|
|
Health related quality of life (HRQOL)
Time Frame: 6 months
|
based on the SF-8 and mental health measurements based on the 5-mental health inventory
|
6 months
|
|
Health related quality of life (HRQOL)
Time Frame: 1 year
|
based on the SF-8 and mental health measurements based on the 5-mental health inventory
|
1 year
|
|
Sexual function
Time Frame: 3 months
|
assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al.
J Sex Med 2004) - Norwegian translation (non-validated)
|
3 months
|
|
Sexual function
Time Frame: 6 months
|
assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al.
J Sex Med 2004) - Norwegian translation (non-validated)
|
6 months
|
|
Sexual function
Time Frame: 1 year
|
assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al.
J Sex Med 2004) - Norwegian translation (non-validated)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Risa AM Lonnee-Hoffmann, md phd, St. Olavs Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2017
Primary Completion (Actual)
February 7, 2019
Study Completion (Actual)
February 7, 2019
Study Registration Dates
First Submitted
February 15, 2017
First Submitted That Met QC Criteria
February 15, 2017
First Posted (Actual)
February 17, 2017
Study Record Updates
Last Update Posted (Actual)
February 8, 2019
Last Update Submitted That Met QC Criteria
February 7, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/1881
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.