Treatment of pelvic venous disorders with venoactive drugs

Comparative Assessment of the Efficacy and Safety of Venoactive Drug Treatment of Pelvic Venous Disorders

This study is testing if a new medication containing diosmin can help relieve chronic pelvic pain in women with pelvic venous disorders.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Pirogov Russian National Research Medical University (Academic / other)
• Locations: 1 site (Moskva)
• Trial ID: NCT06584799 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of diosmin-containing venoactive drugs (VADs) in relieving chronic pelvic pain (CPP) in female patients with pelvic venous disorders (PeVD). A total of 150 women aged 18 to 45 with symptomatic PeVD will be enrolled, and their CPP severity will be assessed using a visual analogue scale before and weekly during the 2-month treatment period. The study will also compare the effectiveness and safety of different diosmin formulations and monitor patient adherence to the treatment. Diagnostic methods include transabdominal and transvaginal duplex ultrasound to confirm the presence of pelvic varicose veins.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 45 with symptomatic pelvic venous disorders and chronic pelvic pain.

Not a fit: Patients who are asymptomatic, post-menopausal, pregnant, or have competing diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate chronic pelvic pain and improve the quality of life for women suffering from pelvic venous disorders.

How similar studies have performed: Previous studies have shown promising results for venoactive drug therapy in treating chronic venous diseases, suggesting potential success for this approach in pelvic venous disorders.

Eligibility criteria

Inclusion Criteria:

* Age from 18 to 45 years;
* The presence of PeVD symptoms (CPP, dyspareunia, discomfort in the hypogastrium, dysuria, vulvar varicose veins);
* The presence of pelvic varicose veins with reflux in them, according to DUS;
* Pelvic venous reflux (PVR) lasting for greater than 1 s, according to DUS;
* Isolated dilation and reflux in the parametrial and uterine veins, according to DUS;
* Absence of competing abnormalities, accompanied by CPP.

Exclusion Criteria:

* Asymptomatic form of the disease;
* Menopause;
* Pregnancy;
* Post-thrombotic disease;
* Neoplasms;
* Competing diseases with CPP;
* Known hypersensitivity to any of the components of the used VAD.

Where this trial is running

Moskva

• Pirogov Russian National Research Medical University — Moskva, Russia (Recruiting)

Study contacts

• Study coordinator: Sergey G Gavrilov, MD, PhD

Conditions Pelvic Venous Disorders; pelvic venous disorders; chronic pelvic pain; venoactive drug therapy; pelvic pain