N/A
N=100
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Pelvic Congestion Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02796092 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Change in Pain Scale — 47; 48; 2; 2 participants — p=>0.999
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fibered platinum coils (Device); Vascular plugs (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Group of Research in Minimally Invasive Techniques
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scale |
47; 48; 2; 2 | >0.999 |
| SECONDARY Improvement of Dyspareunia |
24; 21; 3; 6 | 0.3 |
| SECONDARY Improvement of Urinary Urgency |
6; 6; 1; 0 | >0.999 |
| SECONDARY Improvement of Dysmenorrhea |
24; 31; 3; 4 | >0.999 |
| SECONDARY Satisfaction With the Procedure |
8.22; 7.90 | 0.061 |
| SECONDARY Number of Devices Used |
18.16; 4.06 | <0.001 sig |
| SECONDARY Cost of Treatment |
3295.05; 4069.79 | <0.001 sig |
| SECONDARY Total Intervention Duration |
44.46; 29.02 | <0.001 sig |
| SECONDARY Fluoroscopy Time |
33.41; 19.52 | <0.001 sig |
| SECONDARY Procedure Radiation Dose (DAP) |
354573.00; 189935.60 | <0.001 sig |
| SECONDARY Procedure Radiation Dose (AK) |
947.99; 320.66 | <0.001 sig |
| SECONDARY Complications |
0; 0 | — |
| SECONDARY Complications |
0; 0 | — |
| SECONDARY Need for Re-embolization |
7; 2; 43; 48 | 0.095 |
Summary
This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Presence of chronic abdominal or pelvic pain for more than 6 months
- >6 mm pelvic venous caliber measured by transvaginal US
- Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US
Exclusion Criteria
- Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma
- Glomerular filtration rate <60 ml/min
- History of contrast reaction
- Patients not able to be followed up for at least one year
Data sourced from ClinicalTrials.gov (NCT02796092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.