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Trans­venous occlusion of pelvic vein incompetence

Transvenous occlusion of incompetent pelvic veins as a treatment for chronic pelvic pain in women: A randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15091500
Enrollment
100
Registered
2015-10-14
Start date
2015-07-27
Completion date
Unknown
Last updated
2023-05-08

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

Conditions

Topic: Reproductive health and childbirth

Interventions

Participants are randomly allocated to one of two groups. The participant, researchers and responsible Gynaecologist are blinded to the group allocation. Control Group: Control participants will rec

Sponsors

University Hospital of South Manchester NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged between 18­ and 54 (inclusive)  2. CPP (constant or intermittent lower abdominal or pelvic pain lasting for more than six months) confirmed by a diagnostic committee including a gynaecologist

Exclusion criteria

Exclusion criteria: 1. Pregnant or within 12 months of pregnancy 2. Alternative pathologies that may cause CPP (such as endometriosis, adenomyosis, interstitial cystitis or musculoskeletal pain) as judged by the diagnostic committee 3. Previous hysterectomy 4. Renal failure (eGRF <30ml/min/1.73m2) 5. Previous cardiovascular event such as myocardial infarction, stroke, angina or history of heart failure 6. A diagnosis of malignancy or treated for malignancy over the last 12 months 7. At increased risk of bleeding such as patients on anticoagulation or history of hereditary bleeding disorders 8. Chronic disability that impairs mobility 9. Unable to give informed consent

Design outcomes

Primary

MeasureTime frame
Pain is measured using the Short-form McGill Pain Questionnaire which will be completed by participants either online or via post at baseline, 1 week, 3 months, 6 months and 12 months.

Secondary

MeasureTime frame
Health outcomes are measured using the EuroQol (EQ-5D-3 Level) Questionnaire which will be completed by participants either online or via post at baseline, 1 week, 3 months, 6 months and 12 months.

Countries

England, United Kingdom

Contacts

Public ContactVivak Hansrani
vivak.hansrani@manchester.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026