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Safety and Preliminary Efficacy of Endoscopic Submucosal Injection of Hyaluronic Acid Into the Bladder Wall in Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Sponsor: Sverdlovsk Regional Clinical Hospital No.1

Summary

The goal of this pilot clinical trial is to learn if injecting hyaluronic acid into the bladder wall is safe and if it works to reduce pain and urinary frequency in people with interstitial cystitis (IC), also called bladder pain syndrome (BPS). Who can take part? Adults aged 18 and older who have IC/BPS that did not get better after at least two standard treatments (such as diet changes, oral drugs, or bladder instillations) for 6 months or more. Main questions the study aims to answer: What side effects (medical problems) do participants have after the injection procedure? Does the injection lower pain and reduce how often a person needs to urinate, compared to before the treatment? What will happen in the study? There is no comparison group or placebo (a look-alike substance with no drug). All participants receive the same treatment. Participants will: Have a one-time procedure under intravenous anesthesia (medicine that puts them to sleep) Receive 20 small injections of hyaluronic acid into the bladder wall using a thin tube with a camera (cystoscope) Have small tissue samples taken from the bladder (biopsy) during the same procedure Keep a 3-day diary of their urination Fill out short questionnaires about pain, symptoms, and quality of life Return for follow-up visits at 1 day, 1 week, 4 weeks, 3 and 6 months after the injection. At the 4-week visit, participants will have cystoscopy with bladder biopsy and may receive a second injection if the first one helped. Possible benefits We cannot guarantee that this experimental treatment will help everyone. However, based on years of experience with similar hyaluronic acid injections in other body parts, researchers hope that injecting the substance directly into the bladder wall will give longer-lasting relief than standard bladder instillations. Risks and side effects The most common expected side effects are: Blood in the urine for a few hours or days (usually goes away on its own) Temporary increase in pain or burning when urinating Infection (unlikely; the team will give antibiotics to lower the risk) Serious problems such as bladder wall puncture or allergic reaction are very rare. Participation is voluntary People can join or leave the study at any time without giving a reason. Refusing or stopping will not affect their regular medical care at the hospital. Confidentiality All personal information will be kept private. Results will only be shared in combined, anonymous form (no names or identifying details).

Official title: A Pilot Open-Label Prospective Study of Safety and Preliminary Efficacy of Endoscopic Submucosal Injection of Hyaluronic Acid Into the Bladder Wall in Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

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