If you have been diagnosed with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS), you may be a candidate for this clinical trial.

For additional study information and a list of participating sites please CLICK HERE to visit clinicaltrials.gov
Urigen's ENGAGE-24
trial study page.

URIGEN LOGO




ENGAGE-24
Interstitial Cystitis / Bladder Pain Syndrome Trial
:

Urigen's ENGAGE-24 Clinical Study Trial Flyer
Download the
Clinical Trial Flyer and FAQs
A study to determine if the combination product,
URG101 is safe and effective compared to its individual components, heparin sodium and lidocaine hydrochloride for the treatment of interstitial cystitis/bladder
pain syndrome.


Key Inclusion Criteria:

If you are diagnosed with interstitial cystitis/bladder pain syndrome, you must meet all of the following criteria to participate in the study:

  1. Read, understand, and sign an informed consent form
  2. Be male or female, ≥ 18 years of age
  3. Have moderate-to-severe symptoms of bladder pain of bladder origin for at least 9 months prior to the study
  4. Optional cystoscopy in association with your diagnosis of interstitial cystitis/bladder pain syndrome prior to or at time of screening
  5. At screening complete a questionnaire that measures the symptoms associated with IC/BPS, based on pain, urgency, and frequency of urination (PUF questionnaire) with an overall eligible score
  6. An eligible score for bladder pain is required on the Bladder Pain and Urgency 11-Point Numerical Rating Scales (NRS) on the day of treatment with the study drug
  7. If female and currently taking hormone therapy, have been using a stable dose of hormone therapy for ≥ 3 months

Your active participation in this research study includes 24 hours of assessments after you receive the study drug treatment. Depending on the enrollment process time and the timing of the follow-up phone call (48 or 72 hours), your involvement in the study could last between 3 and 10 days.

For additional study information and a list of participating sites,
please CLICK HERE to visit
the clinicaltrials.gov Urigen's ENGAGE-24 trial study page.