Commentary: Efficacy of Clorpactin in refractory bladder pain syndrome/interstitial cystitis: a randomized controlled trial

Abstract

The management of bladder pain syndrome/interstitial cystitis (BPS/IC) is often arduous, requiring a multi-disciplinary approach combining treatment of lifestyle and dietary modifications with pharmacological oral and/or intra-vesical treatments. Although there are numerous intra-vesical treatments available, none has proven greater efficacy over another. This study is a multi-centre, single-blinded randomized controlled trial [1] investigating the use of Clorpactin instillation in patients with refractory BPS/IC. This is particularly important owing to the current lack of good-quality evidence for the use of Clorpactin which, although reported to be effective in patients with BPS/IC since 1955, lacks controlled trials and is associated with caustic effects. This led to it being an unpopular treatment in BPS/IC. This study randomised 50 subjects, 25 to Clorpactin instillation (0.4% solution, 2 g in 500ml of normal saline) and 25 to hydrodistension (500 ml or less of normal saline alone under 80 cm H20 pressure for 4 min) in patients undergoing cystoscopy under general anaesthesia. The primary outcome was based on Global response Assessment (GRA) at 3 months. Secondary outcomes included the O’Leary Sant Symptom Index (OLSI) and the O’Leary Sant Problem Index (OPLI) questionnaire scores, visual analogue scale (VAS) score for pain and bladder diary parameters. Follow-up was complete in 22 women receiving hydrodistension and 16 receiving Clorpactin. At 3 months, GRA improvement of “much better” or “very much better” was noted in 56% of subjects in the Clorpactin group versus only 4.5% of subjects in the hydrodistension group (p = 0.001). Both the OLSI and the OLPI were significantly improved/lower at 3 months in the Clorpactin group but not in the hydrodistension group. Of note, there was a >50% reduction in VAS pain scores in 56% of subjects in the Clorpactin group versus no reduction in the hydrodistention group. It is important to note that Clorpactin was associated with higher rates of same-day admissions and re-admissions (8 and 6 out of 25 respectively) compared with hydrodistension, which was associated with 3 out of 25 patients requiring same-day admissions and no subjects requiring re-admission. This study suggests that Clorpactin therapy in BPS/IC subjects provides improved short-term symptom relief over hydrodistension. This study provides a foundation for future research to be done comparing Clorpactin with other instillation agents.