Safety and Preliminary Effectiveness of GLX-100 in Participants With Interstitial Cystitis/Painful Bladder Syndrome.

Interstitial cystitis (also called painful bladder syndrome) is a chronic bladder condition that causes ongoing pelvic pain, pressure, and a frequent urgent need to urinate, often with no infection present. It can significantly affect quality of life and is difficult to treat. This study is testing a new medical device called GLX-100, which contains a substance called glycosaminoglycan (GAG) — similar to the natural protective lining of the bladder — that is instilled directly into the bladder to reduce irritation and pain. Participants will receive a series of GLX-100 bladder instillations and be monitored closely for safety and any reduction in pain or other symptoms. This is an early-phase trial, so the primary focus is on whether the treatment is safe and tolerable. This study is open to women aged 18 or older who have had interstitial cystitis symptoms for at least six months and who have a bladder pain score of at least 4 out of 10. Participants must have had a prior cystoscopy to rule out other conditions and have been on stable oral IC/PBS medication for at least three months. Women who are pregnant or breastfeeding, have active urinary tract infections, or have certain other bladder or pain conditions would not be eligible.