Positive impact of a new compressive garment in patients with genital lymphedema: OLYMPY STUDY

Abstract

Abstract Purpose: Genital lymphedema is a chronic debilitating condition associated with highly impaired health-related quality of life (QoL). This prospective multi-center study evaluated the use of a new compressive garment in patients with secondary and primary genital lymphedema. Methods: 32 patients prospectively enrolled were advised to wear the compressive garment for 12 weeks (day and night). The primary endpoint was change in patient-reported QoL at 12 weeks via the patient global impression of change (PGI-C) instrument. Secondary outcomes included change in other QoL measures at 12 weeks (VAS, LyQLI and EQ-5D questionnaires), lymphedema severity (Genital Lymphedema Score (GLS)) and physician assessment (Clinical Global Impression- Improvement (CGI-I)). Safety and tolerability were also assessed. Results: After 12 weeks, improvement was reported in 78.6% of patients (PGI-C). Physician assessment (CGI-I) indicated clinical improvement in 82.8% of patients. Patient assessment of lymphedema symptoms showed a significant decrease in discomfort (p = 0.02) and swelling (p = 0.01). Significant declines in mean global GLS scores (p < 0.0001), and in the proportion of patients reporting heaviness, tightness, swelling or urinary dysfunction (p < 0.05 for all) were also observed. LyQLI scores decreased (indicating improved QoL) in each of the physical, psychosocial (p = 0.05) and practical domains. The compressive garment was well tolerated with high compliance and adverse events (due to swelling or discomfort) led to permanent discontinuation in only 3 patients. Conclusions: Use of a new genital compression garment over 12 weeks improves QoL and clinical measures in patients with genital lymphedema (NCT04602559; Registration: 10/20/2020).