Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-17

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of Injectable Platelet-rich Fibrin in the Treatment of the Female Stress Urinary Incontinence

NCT05617417

Urinary Incontinence Treatment

COMPLETED NA

Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

NCT02680145

Vaginal Vault Prolapse Pelvic Organ Prolapse Uterine Prolapse +1 more

COMPLETED NA

Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia

NCT06528470

Constipation Fecal Incontinence in Children Pelvic Floor Dyssynergia

RECRUITING NA

Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome

NCT06553014

Pain, Chronic

COMPLETED

Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain

NCT06262490

Chronic Perineal Pain Pelvic Floor Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pelvic congestion syndrome (PCS) is a common cause of chronic lower abdominal/pelvic pain, estimated to affect about 40 % of women, predominantly between the ages of 30 and 45.The treatment of PCS depends mainly on the severity of the pain. Non-steroid anti-inflammatory drugs are often used, and contraceptives have a role in cases of pain associated predominantly with menstruation.

Traditionally, conservative approaches, such as pharmacotherapy with venoactive drugs like micronized purified flavonoid fraction (Daflon), have been utilized to address the symptoms of PCS. Daflon has been used to treat venous insufficiency and has demonstrated efficacy in reducing symptoms and improving the quality of life in patients with PCS. Its mechanism of action includes improving venous tone, reducing venous stasis, and exerting anti-inflammatory effects. Endovascular treatment of PCS is challenging and requires occlusion of incompetent pelvic veins.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glue Embolization Pelvic Congestion Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Micronized purified flavonoid fraction (Daflon ®)

Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months.

Group Type ACTIVE_COMPARATOR

Micronized purified flavonoid fraction (Daflon ®)

Intervention Type DRUG

Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months.

Glue embolization

Patients will receive transcatheter glue embolization.

Group Type EXPERIMENTAL

Glue embolization

Intervention Type OTHER

Patients will receive transcatheter glue embolization.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Micronized purified flavonoid fraction (Daflon ®)

Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months.

Intervention Type DRUG

Glue embolization

Patients will receive transcatheter glue embolization.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No