1 Recommendations

1.1 Pentosan polysulfate sodium is not recommended, within its marketing authorisation, for treating bladder pain syndrome with glomerulations or Hunner's lesions in adults with moderate to severe pain, urgency and frequency of urination.

1.2 This recommendation is not intended to affect treatment with pentosan polysulfate sodium that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Bladder pain syndrome is managed with oral treatments, then bladder instillations if symptoms don't improve. Pentosan polysulfate sodium is an oral treatment.

Clinical trials suggest that pentosan polysulfate sodium may be more effective at relieving pain than placebo. A comparison of clinical trials that includes best supportive care and bladder instillations suggests that pentosan polysulfate sodium may have a moderate benefit over these alternatives. But how much benefit it provides is unclear because these treatments haven't been compared directly. Also, the available evidence is not of high quality.

The most plausible cost-effectiveness estimates for pentosan polysulfate sodium are likely to be much higher than what NICE usually considers to be a cost-effective use of NHS resources. So, it cannot be recommended.