Bladder pain syndrome (BPS) is a chronic pain condition associated with injury to the glycosoaminoglycan (GAG) layer. We aimed to prospectively evaluate iAluRil® with multi-centre tertiary urogynaecology collaboration. We hypothesised that iAluRil® (a GAG therapy) would demonstrate equivalent symptom, pain and QOL scores compared to DMSO controls.
iAluRil® was administered for 7 instillations over 3 months in 34 women over 6 sites. 18 historical DMSO controls were matched 2:1. At baseline and 3 months post treatment validated questionnaires were collected.
Both iAluRil® and DMSO were associated with statistically significant improvements in IC/BPS specific questionnaire scores. iAluRil® showed statistically significant improvements in pain, symptoms, and QOL. 45 % of iAluRil® recipients had a greater than 50 % reduction in pain score as represented by the VAS. DMSO was also effective in improving measures of IC/BPS with statistically significant decreases in ICSI and ICPI. There was no statistically significant difference in the size of the effect between DMSO and IAluRil®.
iAluRil® is well tolerated and associated with significant improvements in pain and symptom scores. Almost half of refractory BPS will have a 50 % decrease in pain score at three months post treatment. This effect size is similar to DMSO.
European journal of obstetrics, gynecology, and reproductive biology. 2020 Nov 01 [Epub ahead of print]
J Keane, N Young, J Goh, M Atherton, J Yin, K Moore, P Hall, P Higgs, A Leitch, J Lee, A Rosamilia
Monash Health, Melbourne, VIC, Australia; Monash University, Melbourne, VIC, Australia. Electronic address: ., Monash Health, Melbourne, VIC, Australia., Greenslopes Hospital, Greenslopes, QLD, Australia., Wexford Med Centre, WA, Australia., Hollywood Hospital, Nedlands, WA, Australia., St George Hospital, Kogarah, NSW, Australia; University of New South Wales, Sydney, NSW, Australia., St Andrews Memorial Hospital, Spring Hill, QLD, Australia., Buderim Private Hospital, Buderim, QLD, Australia., Monash Health, Melbourne, VIC, Australia; Vincents Clinic, Darlinghurst, NSW, Australia., Monash Health, Melbourne, VIC, Australia; Monash University, Melbourne, VIC, Australia.