Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

NCT ID: NCT03057067

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-19

Study Completion Date

2019-02-07

Brief Summary

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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

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Conditions

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Pelvic Pain Varicose Veins

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Embolization of pelvic vein varicosities

Intervention Type PROCEDURE

Embolization of pelvic vein varicosities

Interventions

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Embolization of pelvic vein varicosities

Embolization of pelvic vein varicosities

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Risa AM Lonnee-Hoffmann, md phd

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2016/1881

Identifier Type: -

Identifier Source: org_study_id

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