Abstract
Objective: To assess the long-term effects of Dienogest on clinical complaints and nodule sizes in women affected by recto-sigmoid deep endometriosis (DE). Methods: This was a single-center longitudinal prospective observational study comprising a consecutive series of women affected by recto-sigmoid DE, who underwent medical treatment with Dienogest (2 mg daily continuous). All women underwent clinical visits and transvaginal sonography (TVS) with bowel preparation prior to starting therapy and at 3-6-month intervals for at least 12 months. Clinical complaints such as dysmenorrhea, dyspareunia and dyschezia were assessed using a visual analog scale (VAS). The DE recto-sigmoid lesion was measured in the three orthogonal planes. The lesion's volume was estimated using the prolate ellipsoid formula. The maximum diameter and lesion volume were used for analysis. Patients' complaints and lesion sizes before starting the treatment and at final follow-up were compared. Results: From January 2017 to July 2020, 125 patients were consecutively recruited (mean age: 37 years, ranging from 20 to 50 years). The median follow-up period was 47.8 months (range: 12-74 months). We did not observe a significant correlation between the severity of the symptoms and the lesion size prior to starting therapy. Clinical complaints improved significantly during treatment (88% of women were symptomatic at initial visit, versus 53% at final follow-up, p < 0.001). The median lesion volume significantly decreased (median initial volume vs. final volume: 1.1 mL vs. 0.9 mL, p = 0.017). However, the median maximum lesion diameter did not change significantly (26.0 mm vs. 25.0 mm, p = 0.779). Conclusions: Long-term Dienogest therapy significantly relieves clinical symptoms related to recto-sigmoid DE. This is accompanied by a significant reduction in the lesion volume but not the maximum lesion diameter.