Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03057067

Enrollment

Registered

2017-02-17

Start date

2017-05-19

Completion date

2019-02-07

Last updated

2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Pain, Varicose Veins

Keywords

Embolization, Therapeutic, Pelvis

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.

Interventions

PROCEDUREEmbolization of pelvic vein varicosities

Embolization of pelvic vein varicosities

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
chronic pelvic pain	3 months	assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

Secondary

Measure	Time frame	Description
Health related quality of life (HRQOL)	3 months	based on the SF-8 and mental health measurements based on the 5-mental health inventory
Sexual function	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)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026