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# Interstitial Cystitis Drug Effectiveness Guidance
- URL: https://www.fdaweb.com/interstitial-cystitis-drug-effectiveness-guidance/
- Published: 2019-12-04T12:00:00.000Z
- Updated: 2026-09-14T15:55:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145642

FDA has published a draft guidance, *Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment*, with recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome. The [document](https://www.fda.gov/media/133190/download?ref=fdaweb.com) incorporates recommendations the agency received at a 12/2017 advisory committee meeting on trial design features, including enrollment criteria and acceptable effectiveness endpoints for drugs intended to treat IC/BPS.

Included in the draft are an Introduction, Background, and Clinical Trial Design Features — Key Considerations, including enrollment criteria, effectiveness endpoints, and other critical trial design considerations.