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)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
研究概览
简要总结
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).
详细描述
Study design in detail This is a prospective, open-label, single-center, pilot phase I-II clinical trial. No randomization or blinding is applied. All enrolled participants receive the same intervention. The study aims to enroll 10-20 evaluable participants with refractory interstitial cystitis/bladder pain syndrome (IC/BPS).
Rationale for submucosal injection of non-cross-linked hyaluronic acid Hyaluronic acid (HA) is a natural component of the extracellular matrix. Intravesical HA instillations are a standard therapy for IC/BPS but require frequent administration (up to 3 times per week for ≥6 months) and provide only temporary relief in many patients. Submucosal injection is hypothesized to achieve a higher and more prolonged local concentration of HA in the lamina propria, enhancing glycosaminoglycan layer repair, reducing inflammation, and stimulating fibroblast activity and neocollagenesis. This technique is technically identical to endoscopic botulinum toxin injection, which has an established safety profile in the bladder.
Extrapolated safety evidence
The safety of submucosal non-cross-linked HA injection is supported by extensive experience in other mucosal sites:
Laryngoplasty (vocal cords): no serious adverse events (SAEs) in published case series; histological evidence of biocompatibility without chronic inflammation or necrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hyaluronic Acid Injection Group
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.
干预措施: Hyaluronic Acid (HA) (Drug)