Clorpactin is an antibacterial agent with limited evidence for its use as instillation therapy in patients with bladder pain syndrome/interstitial cystitis (BPS/IC). This was a multi-centre, single-blinded randomized controlled trial to investigate whether Clorpactin instillation results in symptom improvement in patients with refractory BPS/IC.
Fifty women with refractory BPS/IC were randomized to undergo cystoscopy/hydrodistension (25) or instillation of Clorpactin 0.4% solution (25) under general anaesthesia. Primary outcome was based on Global Response Assessment (GRA) at 3 months; secondary outcomes were based on O'Leary Sant Symptom (OLSI) and Problem (OLPI) questionnaire scores, visual analogue scale (VAS) score for pain and bladder diary parameters.
Complete follow-up data were available on 22 in the hydrodistension group and 16 in the Clorpactin group. GRA improvement was 4.5% for hydrodistension and 56% for Clorpactin (p = 0.001) at 3 months. Reduction in mean total scores for OLSI (14.1 to 9.1; p = 0.004) and OLPI (12.6 to 7.4; p = 0.001) was seen in the Clorpactin group only. VAS pain scores were reduced in the Clorpactin group only (7.4 to 3.3; p < 0.001). Post-treatment VAS pain scores did not differ between groups although 6/25 (24%) women in the Clorpactin group required admission for pain compared to 1/25 (4%) in the hydrodistension group.
Clorpactin treatment results in significant improvement in BPS/IC symptoms, bother and pain based on the GRA, OLSI/OLPI and VAS pain scores at 3 months post-treatment compared to cystoscopy/hydrodistension. These conclusions are limited by the high loss to follow-up in both groups.
International urogynecology journal. 2021 Jan 16 [Epub ahead of print]
Kristina Cvach, Anna Rosamilia, Peter Dwyer, Yik Lim, Alison DeSouza, Linli Ow, Elizabeth Thomas, Christine Murray, Alison Leitch, Lore Schierlitz
Mercy Hospital for Women, Melbourne, Australia. ., Monash Health, Melbourne, Australia., Mercy Hospital for Women, Melbourne, Australia.