A Pilot Retrospective Evaluation of Colpofix® Ovules for the Management of Radiation-Induced Vaginal Toxicity in Patients with Mid-Low Rectal and Anal Cancers

Background/Objectives: Pelvic radiotherapy (RT) for mid–low rectal and anal cancers frequently causes acute and late vaginal toxicity, including dryness, irritation, and dyspareunia, with a substantial impact on quality of life. Evidence supporting targeted interventions for radiation-induced vaginal mucosal changes remains limited. This exploratory retrospective study evaluated the association between daily use of Colpofix® Ovules and temporal changes in patient-reported vaginal symptoms and Vaginal Health Index (VHI) scores in women undergoing pelvic RT. Methods: Twenty women treated with pelvic RT or chemoradiotherapy between 2024 and 2025 were included. Vaginal symptoms were assessed using a Numerical Rating Scale (NRS 0–10), and mucosal status was evaluated using the VHI (5–25). Assessments were performed at baseline (T0), end of RT (T1), 3 months (T2), and 6 months (T3). Due to the retrospective nature of the dataset, only aggregated summary values were available; analyses were therefore descriptive and aimed at characterizing temporal trends. Results: A clear and progressive reduction in vaginal dryness, irritation, reduced lubrication, and dyspareunia was observed from T0 to T3, with improvements already evident at T1 and further consolidation at T2–T3. VHI scores increased from a mean of 10.8 at baseline to 21.0 at 6 months, reflecting a consistent trend toward mucosal recovery across all domains. In the anal cancer subgroup, the trend toward improvement in dysuria did not meet conventional thresholds for statistical significance (p = 0.073). At T3, 90% of patients reported perceived benefit (55% marked, 35% mild). No adverse events attributable to Colpofix® were documented. Conclusions: In this small retrospective cohort, daily use of Colpofix® Ovules was associated with favorable temporal trends in both vaginal symptoms and VHI scores up to 6 months after pelvic RT. These exploratory findings support further prospective controlled studies to better define the potential role of Colpofix® in managing vaginal mucosal changes during pelvic radiotherapy.