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 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: U7-2026
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Cystitis, Interstitial; Chronic Pain

Keywords

Bladder Pain Syndrome; IC/BPS; Hyaluronic Acid Injection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  Adverse events (AEs) are assessed and graded using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The analysis includes all participants who received at least one injection. The total number and proportion of participants experiencing any AE, as well as AEs of Grade 2 or higher, will be reported. This includes pre-specified expected events such as transient hematuria, urinary tract infection, and injection site pain. Higher scores on the CTCAE scale represent a more severe adverse event.

  From day of procedure up to 30 days

Secondary Outcomes (6)

• Change in Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) Scores

  Baseline, Week 4, Month 3

• Change in Pelvic Pain and Urgency/Frequency (PUF) Score

  Baseline, Week 4, Month 3

• Change in Pain Intensity Measured by Visual Analog Scale (VAS)

  Baseline (screening), Week 4, Month 3

• Change in Functional Bladder Capacity

  Baseline, Week 4, Month 3

• Patient Global Impression of Improvement (PGI-I)

  Week 4, Month 3

Study Arms (1)

Hyaluronic Acid Injection Group

EXPERIMENTAL

Participants receive a single session of 20 submucosal injections of non-cross-linked hyaluronic acid into the bladder wall, with optional repeat at week 4.

Drug: Hyaluronic Acid (HA)

Interventions

Hyaluronic Acid (HA) DRUG

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

Hyaluronic Acid Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged ≥ 18 years.
• Confirmed diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) based on cystoscopic findings (glomerulations after hydrodistension or Hunner's lesions).
• Refractory to at least 2 lines of standard therapy (e.g., dietary modifications, oral medications, intravesical hyaluronic acid instillations, hydrodistension) for ≥ 6 months.
• Pain score ≥ 4 on a 0-10 Visual Analog Scale (VAS) at screening.
• Ability and willingness to provide written informed consent and to complete a 3-day voiding diary.

You may not qualify if:

• Active urinary tract infection (bacteriuria \> 10⁴ CFU/mL).
• History of genital herpes.
• Severe renal failure (eGFR \< 30 mL/min/1.73 m²).
• Known allergy to hyaluronic acid or any component of the study product.
• Pregnancy or breastfeeding.
• Psychiatric disorders or substance abuse that would interfere with study participation.
• Participation in another clinical study within 30 days prior to enrollment.

Sponsors & Collaborators

• Sverdlovsk Regional Clinical Hospital No.1: lead

Related Publications (1)

• Pyo JS, Cho WJ. Systematic Review and Meta-Analysis of Intravesical Hyaluronic Acid and Hyaluronic Acid/Chondroitin Sulfate Instillation for Interstitial Cystitis/Painful Bladder Syndrome. Cell Physiol Biochem. 2016;39(4):1618-25. doi: 10.1159/000447863. Epub 2016 Sep 15.

  PMID: 27627755 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial; Chronic Pain

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Igor V Bazhenov, Professor, MD

  Sverdlovsk Regional Clinical Hospital No.1

  STUDY CHAIR

Central Study Contacts

Ekaterina S Philippova, Professor, MD

CONTACT

+79126380286; filippova.cat@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share