Comparing glue embolization and conservative treatment for pelvic congestion syndrome
Glue Embolization Versus Conservative Treatment for Pelvic Congestion Syndrome: A Randomized Trial
This study is testing whether a new glue treatment works better than standard care for women aged 30 to 50 with pelvic congestion syndrome to help relieve their chronic pelvic pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, ElGharbia) |
| Trial ID | NCT06560294 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of glue embolization compared to conservative treatment methods for pelvic congestion syndrome (PCS), a condition that causes chronic pelvic pain in women. The study will involve women aged 30 to 50 who experience symptoms of PCS. Participants will receive either the micronized purified flavonoid fraction (Daflon) or undergo glue embolization to occlude incompetent pelvic veins. The outcomes will be assessed to determine which treatment provides better relief from symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30 to 50 who are experiencing symptoms of pelvic congestion syndrome.
Not a fit: Patients who are pregnant, breastfeeding, or have alternative causes of chronic pelvic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women suffering from pelvic congestion syndrome.
How similar studies have performed: While traditional conservative treatments have been used for PCS, the approach of glue embolization is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged from 30 to 50 years. * Complaining from pelvic congestion syndrome. Exclusion Criteria: * Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers. * Patients who are treated with opiates to reduce pelvic pain in the period before the study. * Patient with history of contrast allergy * Patient with renal impairment * Patient has alternative gynecological cause of chronic pelvic pain as pelvic inflammatory disease (PID), endometriosis, fibroid, adenomyosis, ovarian cyst * Patient underwent any previous intervention for pelvic congestion syndrome as laparoscopy or surgery.
Where this trial is running
Tanta, ElGharbia
- Tanta University — Tanta, ElGharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed I Eleissawy, MD
- Email: mohamed.elesawy@med.tanta.edu.eg
- Phone: 00201110036328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.