Venoactive Drug Treatment of Pelvic Venous Disorders
NCT Number: NCT06584799
Acronym: VENOTREAT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Pelvic Venous Disorders
Interventions: DRUG: diosmin-containing venoactive drug
Sponsor: Pirogov Russian National Research Medical University
Sex: FEMALE
Age: ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-02
Locations: Pirogov Russian National Research Medical University, Moskva, 117513, Russian Federation

Summary:
Venoactive drug (VAD) therapy is one of the most effective methods of treating chronic venous diseases (CVD). Numerous studies have proven its high efficacy in relieving symptoms of CVD, such as leg pain and swelling, leg heaviness and fatigue. Pelvic venous disorders (PeVDs) represent a group of pathological conditions including varicose veins of the pelvis and vulva, and compression stenoses of the left renal and common iliac veins. Although PeVDs are associated with venous lesions of the pelvis and retroperitoneum and have specific clinical manifestations, they are one of the forms of CVD and constitute a separate cohort. A number of studies on the VAD usage in PeVD indicate the wide possibilities of this type of treatment in eliminating chronic pelvic pain (CPP), the most dramatic symptom of PeVD, which is the main cause of disability and decreased quality of life, social and daily activity in women with PeVD. Currently, a variety of VADs are presented on the pharmaceutical market, which, according to the product labels, provide effects not only on the venous outflow from the lower extremities, but also on venous hemodynamics in the pelvis. At the same time, a literature analysis shows that micronized purified flavonoid fraction (MPFF) has the greatest evidence base obtained in the efficacy and safety studies of VADs in PeVD. Nevertheless, patients are rarely interested in the scientific dossier of drugs, and in the real practice the patients with PeVD and CPP most often ask: "What is the best drug to use for the CPP relief?" This is quite understandable, as it is CPP in PeVD that results not only in disability, but also in family conflicts, psycho-emotional stress and depressive states. In this regard, patients seek to get rid of pain as soon as possible and strive to use the most effective drug. An extensive scientific base of comparative studies on the use of various VADs in patients with CVD and PeVD has been accumulated to date. However, the literature is lack of any data on the comparative efficacy and safety of VADs in the treatment of patients with PeVD. This, in turn, makes not possible for doctors and patients to choose the optimal and most effective drug based on the objective research data. All the above has predetermined the purpose of the planned study as evaluating the efficacy and safety of different VADs in the treatment of female patients with PeVD.

Primary Outcome Measures: Severety of the chronic pelvic pain, Evaluation of the efficacy of venoactive drug treatment on chronic pelvic pain by using visual analogue scale, Every weekly until 8 weeks according to a visual analogue scale from 0 to 10 points, 10 points is the worst result
Secondary Outcome Measures: Side and adverse effects, Assessment of the frequency and type of of side and adverse effects of venoactive drug therapy, during the treatment until 8 weeks