Back to resultsEmbolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Primary Purpose
Pelvic Pain, Varicose Veins
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Embolization of pelvic vein varicosities
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Pain focused on measuring Embolization, Therapeutic, Pelvis
Eligibility Criteria
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
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pelvic vein embolization
Arm Description
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
Outcomes
Primary Outcome Measures
chronic pelvic pain
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
chronic pelvic pain
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
chronic pelvic pain
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
Secondary Outcome Measures
Health related quality of life (HRQOL)
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Health related quality of life (HRQOL)
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Health related quality of life (HRQOL)
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Sexual function
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)
Sexual function
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)
Sexual function
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03057067
Brief Title
Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Official Title
Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
difficulties recruiting
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Varicose Veins
Keywords
Embolization, Therapeutic, Pelvis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital are eligible for initial assessment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pelvic vein embolization
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Embolization of pelvic vein varicosities
Intervention Description
Embolization of pelvic vein varicosities
Primary Outcome Measure Information:
Title
chronic pelvic pain
Description
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
Time Frame
3 months
Title
chronic pelvic pain
Description
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
Time Frame
6 months
Title
chronic pelvic pain
Description
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Health related quality of life (HRQOL)
Description
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Time Frame
3 months
Title
Health related quality of life (HRQOL)
Description
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Time Frame
6 months
Title
Health related quality of life (HRQOL)
Description
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Time Frame
1 year
Title
Sexual function
Description
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)
Time Frame
3 months
Title
Sexual function
Description
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)
Time Frame
6 months
Title
Sexual function
Description
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)
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risa AM Lonnee-Hoffmann, md phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
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