Study of Amniotic Membrane Therapy for Interstitial Cystitis and Painful Bladder Syndrome in Adult Women

What this Trial Is About

Researchers are evaluating amniotic membrane therapy for women with interstitial cystitispainful bladder syndrome ICPBS, a condition marked by bladder or pelvic pain along with urinary frequency and urgency. This study aims to determine if this therapy can improve symptoms significantly, using validated questionnaires. ICPBS symptoms vary in severity and affect quality of life, and current treatments include behavior changes, medications, injections, and sometimes surgery. Amniotic membranes have been used in wound healing and show promise for bladder treatment, but no randomized controlled trials have been done yet. The study involves two groups randomized to receive either amniotic membrane therapy or a placebo. Both groups undergo cystoscopy under general anesthesia, where injections are made into the bladder muscle at multiple sites. The amniotic membrane group receives 100 mg of micronized Clarix FLO diluted in saline, while the placebo group receives saline alone. The injections are carefully placed to avoid certain bladder areas. This trial is double-blind, meaning neither the participants nor the researchers know who receives which treatment during the study. Participants will be followed for 12 weeks after treatment with clinical evaluations and symptom questionnaires at 2, 4, 8, and 12 weeks. Additional urine cultures and bladder residual volume tests will be done at 2 and 4 weeks. Researchers will measure changes in symptom scores, including the Interstitial Cystitis Symptom Index and other related scales, to assess the therapys effects. They will also monitor for side effects like urinary tract infections or urinary retention. The total participation duration is about three months post-treatment.

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome