Back to resultsThe Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
Primary Purpose
Venous Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
embolotherapy of incompetent gonadal and iliac veins
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency
Eligibility Criteria
Inclusion Criteria:
- premenopausal women ovarian point tenderness post coital pain atypical lower limb varices
Exclusion Criteria:
- endometriosis diverticulitis fasciitis psychosexual dysfunction
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
perimenopausal women
Outcomes
Primary Outcome Measures
The difference in pain score before and after therapy
validated analogue scoring of pain From 0 to 10 according to symptoms improvement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03652025
Brief Title
The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
Official Title
The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Anticipated)
Primary Completion Date
April 15, 2019 (Anticipated)
Study Completion Date
June 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
pelvic congestion is the most recognized consequence of pelvi-perineal venous insufficiency .
chronic pelvic pain prevalence is about 26.6 %in egypt. this research is going to evaluate the effectiveness of foam sclerotherapy and to conclude diagnostic and therapeutic algorithm for this problem.
Detailed Description
this study includes clinical and imaging and interventional aspects. detailed history and comprehensive examination of the patient. duplex ultrasonography to detect pelvic varices and presence of reflux. renal and left iliac venogram is usually the first step in the evaluation of compressive syndrome. then cannulate the gonadal and internal iliac veins selectively. contrast medium injected , the incompetent gonadal veins are generally dilated and the contrast pools in the pelvis after injection. embolization by injecting afoam sclerosant as distally as possible to occlude the pelvic venous plexus using occlusion balloon proximal.
follow up assessment by VAS score and duplex imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
premenopausal women with dull aching pain with ovarian point tenderness and post coital pain.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
perimenopausal women
Intervention Type
Procedure
Intervention Name(s)
embolotherapy of incompetent gonadal and iliac veins
Intervention Description
minimally invasive
Primary Outcome Measure Information:
Title
The difference in pain score before and after therapy
Description
validated analogue scoring of pain From 0 to 10 according to symptoms improvement
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
premenopausal women ovarian point tenderness post coital pain atypical lower limb varices
Exclusion Criteria:
endometriosis diverticulitis fasciitis psychosexual dysfunction
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
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