Key Eligibility Criteria
Identifying eligible patients
Key Inclusion Criteria
- Adults between the ages of 18–70
- Subject has been diagnosed with IC/BPS by a physician, urologist or other clinician
- Subject has chronic bladder pain associated with filling the bladder for six months or more
- Subject has experienced at least one of the following urinary symptoms related to IC/BPS for six months or more:
- Nocturia ≥2 voids/night
- Daytime frequency >8×/day
- Urgency
Key Exclusion Criteria
- Subject has pelvic floor dysfunction or vulvodynia that, in the opinion of the investigator, would be difficult to discriminate from bladder pain
- Subject has anal fissure, anal abscess, inflammatory bowel disease, active proctitis or any other condition that can be a contraindication to using a rectal foam or bias the evaluation of efficacy and safety of the product
- Subject has had two or more UTIs within 90 days of the Screening Visit
For a more complete list of eligibility criteria required for participation in the study, please see Clinicaltrials.gov.
ABOUT IC/BPS
ABOUT THE STUDY