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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)

NCT07658118 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-06-25

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Hyaluronic Acid (HA)

Non-cross-linked hyaluronic acid solution 10 mg/mL for submucosal injection

Sponsors & Collaborators

  • Sverdlovsk Regional Clinical Hospital No.1

    lead NETWORK

Principal Investigators

  • Igor V Bazhenov, Professor, MD · Sverdlovsk Regional Clinical Hospital No.1

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-12-31
Completion
2027-01-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658118 on ClinicalTrials.gov