Trans­venous occlusion of pelvic vein incompetence

Not Applicable

Completed

• Conditions: Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth; Pregnancy and Childbirth; Chronic pelvic pain in women

• Registration Number: ISRCTN15091500
• Lead Sponsor: niversity Hospital of South Manchester NHS Foundation Trust

Brief Summary

2023 Results article in https://doi.org/10.1111/1471-0528.17512 (added 25/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-14
• Study Completion: 2018-09-28
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.