Pelvic Congestion Syndrome (PCS) is a chronic condition characterized by varicose veins in the pelvic region, leading to persistent or recurring pelvic pain, especially in multiparous women. Symptoms include pain during or after intercourse, heaviness or discomfort in the lower abdomen, urinary symptoms, and menstrual irregularities. It is commonly associated with chronic pelvic venous insufficiency.. Venous insufficiency (chronic) (peripheral)
Conditions
Interventions
Intervention 1: Intervention group: Participants will receive Micronized Purified Flavonoid Fraction (MPFF), commercially available as Daflon® 500 mg (containing 450 mg diosmin and 50 mg hesperidin).
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 60 Adult women diagnosed with pelvic congestion syndrome (clinical chronic pelvic pain plus supporting imaging or clinical criteria). Willingness to provide informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding. Use of other venotonic or anticoagulant medications that could affect venous symptoms. Significant comorbidities (e.g. uncontrolled diabetes, severe cardiovascular, hepatic or renal disease). Other identifiable causes of chronic pelvic pain (e.g. active endometriosis, pelvic inflammatory disease, uterine fibroids causing symptoms). Known allergy or contraindication to Diosmin or dobesilate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total pelvic symptom severity score, based on a standardized pelvic congestion syndrome questionnaire, in women with confirmed pelvic congestion syndrome, before and after each treatment period. The score reflects severity of pelvic pain, dyspareunia, urinary symptoms, varicosities, and functional impairment. Timepoint: Measured at baseline (prior to the start of intervention) and after 12 weeks of treatment with each drug (Daflon and Calcium Dobesilate), before crossover or end of study. Method of measurement: Standardized pelvic congestion syndrome symptom questionnaire, including multiple domains rated on a five-point Likert scale (from 1 = no symptoms to 5 = very severe symptoms), administered via face-to-face interview by blinded assessor.;Change in the severity of dyspareunia (pain during or after sexual intercourse) measured before and after treatment in women with pelvic congestion syndrome. Timepoint: Measured at baseline and after 12 weeks of treatment with each intervention (Daflon and Calcium Dobesilate). Method of measurement: Standardized pelvic congestion syndrome symptom questionnaire, item on dyspareunia scored on a five-point Likert scale (1 = no pain to 5 = very severe pain), administered via face-to-face interview.;Change in the domain score for physical activity limitation caused by pelvic congestion syndrome symptoms (e.g., difficulty performing housework, shopping, sports). Timepoint: Measured at baseline and after 12 weeks of treatment with each intervention. Method of measurement: Standardized pelvic congestion syndrome symptom questionnaire, physical activity limitation subscale, scored on a five-point Likert scale, completed by the patient and reviewed by the evaluator.;Change in emotional distress score, including symptoms such as irritability, fatigue, anxiety, and depressive mood, in women with pelvic congestion syndrome. Timepoint: Measured at baseline and after 12 weeks of treatment with each intervention (Daflon and Cal | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in menstrual symptoms, including cycle irregularity, heavy or prolonged bleeding, and premenstrual discomfort, in women with pelvic congestion syndrome. Timepoint: Measured at baseline and after 12 weeks of treatment with each intervention. Method of measurement: Standardized pelvic congestion syndrome symptom questionnaire, menstrual symptoms subscale, scored on a five-point Likert scale, completed by the patient.;Patient global assessment of improvement in symptoms of pelvic congestion syndrome after each treatment period. Timepoint: Assessed at the end of each 12-week treatment period. Method of measurement: Single-item global improvement question rated by the patient (e.g., much better, better, no change, worse, much worse), documented by the study investigator. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactPouya Tayebi
Babol University of Medical Sciences
Outcome results
None listed