Pelvic PainNCT03057067
Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
A study testing Embolization of pelvic vein varicosities in people with Pelvic Pain and Varicose Veins, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Pain, Varicose Veins
- What is being tested?
- Embolization of pelvic vein varicosities
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- 19 May 2017to 7 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to communicate in Norwegian
- Known endometriosis
- Uterine myoma, uterine anomalies, or cancer
- Postmenopausal
- not having been pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Embolization of pelvic vein varicosities
- Keywords
- Embolization, Therapeutic, Pelvis
- Medical subject headings
- Pelvic Pain, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization of pelvic vein varicositiesProcedure or surgery
Embolization of pelvic vein varicosities
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Embolization of pelvic vein varicosities |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic pelvic pain
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
Measured: 3 months
chronic pelvic pain
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
Measured: 6 months
chronic pelvic pain
assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
Measured: 1 year
Secondary outcomes (6)
Health related quality of life (HRQOL)
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Measured: 3 months
Health related quality of life (HRQOL)
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Measured: 6 months
Health related quality of life (HRQOL)
based on the SF-8 and mental health measurements based on the 5-mental health inventory
Measured: 1 year
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)
Measured: 3 months
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)
Measured: 6 months
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start19 May 2017
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Why it stopped: difficulties recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Risa AM Lonnee-Hoffmann, md phd, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057067
- Sponsor's protocol ID
- 2016/1881
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
- ClinicalTrials.gov ID
- NCT03057067
- Acronym / sponsor ID
- 2016/1881
- Conditions
- Pelvic Pain, Varicose Veins
- Keywords
- Embolization, Therapeutic, Pelvis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 19 May 2017 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| pelvic vein embolization | Experimental | Procedure: Embolization of pelvic vein varicositiesfemale patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital, Trondheim, Norway |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Inability to communicate in Norwegian
- Known endometriosis
- Uterine myoma, uterine anomalies, or cancer
- Postmenopausal
- not having been pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embolization of pelvic vein varicositiesEmbolization of pelvic vein varicosities | Procedure or surgery | pelvic vein embolization |
Primary outcome
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
6 secondary outcomes
Health related quality of life (HRQOL)
Time frame: 3 months
Health related quality of life (HRQOL)
Time frame: 6 months
Health related quality of life (HRQOL)
Time frame: 1 year
Sexual function
Time frame: 3 months
Sexual function
Time frame: 6 months
Sexual function
Time frame: 1 year
Results and safety
The study was stopped early (reason given: difficulties recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risa AM Lonnee-Hoffmann, md phd principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization of pelvic vein varicosities in people with Pelvic Pain and Varicose Veins, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic pelvic pain (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.