Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

NCT03057067 | Terminated

• 1 other identifier: 2016/1881
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Varicose Veins

Keywords

Embolization, Therapeutic; Pelvis

Outcome Measures

Primary Outcomes (3)

• chronic pelvic pain

  assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

  3 months

• chronic pelvic pain

  assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

  6 months

• chronic pelvic pain

  assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

  1 year

Secondary Outcomes (6)

• Health related quality of life (HRQOL)

  3 months

• Health related quality of life (HRQOL)

  6 months

• Health related quality of life (HRQOL)

  1 year

• Sexual function

  3 months

• Sexual function

  6 months

Study Arms (1)

pelvic vein embolization

EXPERIMENTAL

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

Procedure: Embolization of pelvic vein varicosities

Interventions

Embolization of pelvic vein varicosities PROCEDURE

Embolization of pelvic vein varicosities

pelvic vein embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to communicate in Norwegian
• Known endometriosis
• Uterine myoma, uterine anomalies, or cancer
• Postmenopausal
• not having been pregnant

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Pelvic Pain; Varicose Veins

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Risa AM Lonnee-Hoffmann, md phd

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 17, 2017
• Study Start: May 19, 2017
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

NO (1)