NCT03652025

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

August 27, 2018

Last Update Submit

August 27, 2018

Conditions

Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

  • The difference in pain score before and after therapy

    validated analogue scoring of pain From 0 to 10 according to symptoms improvement

    one year

Study Arms (1)

Study group

EXPERIMENTAL

perimenopausal women

Procedure: embolotherapy of incompetent gonadal and iliac veins

Interventions

embolotherapy of incompetent gonadal and iliac veinsPROCEDURE

minimally invasive

Study group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • premenopausal women ovarian point tenderness post coital pain atypical lower limb varices

You may not qualify if:

  • endometriosis diverticulitis fasciitis psychosexual dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: premenopausal women with dull aching pain with ovarian point tenderness and post coital pain.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

October 15, 2018

Primary Completion

April 15, 2019

Study Completion

June 15, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08