1 Recommendations

1.1 Pentosan polysulfate sodium is recommended as an option for treating bladder pain syndrome with glomerulations or Hunner's lesions in adults with urinary urgency and frequency, and moderate to severe pain, only if:

  • their condition has not responded to an adequate trial of standard oral treatments

  • it is not offered in combination with bladder instillations

  • any previous treatment with bladder instillations was not stopped because of lack of response

  • it is used in secondary care and

  • the company provides pentosan polysulfate sodium according to the commercial arrangement.

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 causes extreme pain and severely affects quality of life. It is challenging to treat and there is an unmet need for other treatments. It is currently 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 modest 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.

Pentosan polysulfate sodium is not cost effective compared with best supportive care. But the most plausible cost-effectiveness estimates for pentosan polysulfate sodium compared with bladder instillations are likely to be a cost-effective use of NHS resources. So, it is recommended for a defined population.

  • National Institute for Health and Care Excellence (NICE)