Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

• ClinicalTrials.gov Identifier: NCT03057067
• Recruitment Status: Terminated
• First Posted: February 17, 2017
• Last Update Posted: February 8, 2019
• Sponsor: St. Olavs Hospital
• Information provided by (Responsible Party): St. Olavs Hospital

Tracking Information

• First Submitted Date: February 15, 2017
• First Posted Date: February 17, 2017
• Last Update Posted Date: February 8, 2019
• Actual Study Start Date: May 19, 2017
• Actual Primary Completion Date: February 7, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 15, 2017)

• chronic pelvic pain [ Time Frame: 3 months ]
  assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
• chronic pelvic pain [ Time Frame: 6 months ]
  assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
• chronic pelvic pain [ Time Frame: 1 year ]
  assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 15, 2017)

• 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
• 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
• 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
• 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)
• 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)
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
• Official Title: Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment

Condition

• Pelvic Pain
• Varicose Veins

Intervention

Procedure: Embolization of pelvic vein varicosities

Embolization of pelvic vein varicosities

Study Arms

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

Intervention: Procedure: Embolization of pelvic vein varicosities

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 7, 2019): 3
• Original Estimated Enrollment (submitted: February 15, 2017): 30
• Actual Study Completion Date: February 7, 2019
• Actual Primary Completion Date: February 7, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT03057067
• Other Study ID Numbers: 2016/1881
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: St. Olavs Hospital
• Study Sponsor: St. Olavs Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Risa AM Lonnee-Hoffmann, md phd; St. Olavs Hospital

• PRS Account: St. Olavs Hospital
• Verification Date: February 2019