Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Interstitial Cystitis Symptom Index (ICSI) score
研究概览
简要总结
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/ or discomfort associated with urinary frequency and urgency.
The primary objective of this study is to determine the efficacy of amniotic membrane therapy in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement in validated symptom questionnaires.
详细描述
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/or discomfort associated with urinary frequency and urgency. These symptoms vary in severity and are known to cause significant impact on quality of life. Current recommended therapies include behavior modifications, stress management practices, physical therapy, oral pharmacologic pain management agents, intravesical instillations, hydrodistension, fulguration of bladder lesions and/or triamcinolone injections, intradetrusor onabotulinumtoxin A injections, neuromodulation, and major surgery.
Amniotic membranes, Clarix FLO™, have been used to assist in wound healing in many fields of medicine, and its use has evolved over the last century to various applications in regenerative medicine. A novel study using amniotic membranes for bladder therapy has showing promising preliminary results in a small cohort study of 10 females with recalcitrant IC/PBS. These women underwent intradetrusor injections of micronized amniotic membranes and had significant improvement of voiding symptoms and bladder pain over 3 months with no adverse events. No randomized controlled trials (RCT) of amniotic bladder therapy have been conducted to date. The proposed study would be the first RCT assessing the efficacy of amniotic membrane injections with Clarix FLO™ and has the potential to make significant impacts in the management and treatment of patients with IC/PBS.
Clarix FLO™ is a sterile, particulate human amniotic membrane and umbilical cord tissue product that is aseptically processed in compliance with current Good Tissue Practices from the same donated human tissue (placenta) after determination of eligibility and placenta/cord suitability. Amniotic Membrane and Umbilical Cord products are currently designated by the FDA as tissue products under PHS Act 361 HCT/P (human cells, tissues and cellular and tissue-based products). Clarix FLO™ does not contain living cells.
Patients will then be followed with clinical evaluation and questionnaires repeated at 2, 4, 8 and 12 weeks post-operatively. Additional urine culture and post void residuals will be repeated at 2 and 4 weeks post-operatively. Primary Objective: Determine the efficacy of amniotic bladder therapy (ABT) in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement
- Clinically-meaningful indicator defined as: 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
At time of surgery, the surgeon will be given a sealed envelope containing a sterile syringe of either 10 mL of 0.9% preservative-free sodium chloride or 100 mg of commercially available micronized AM (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age or older
- •English Speaking
- •Diagnosis of IC/PBS
- •Have failed at least one prior treatment for IC/PBS
排除标准
- •Patients less than 18 years of age
- •Unable to provide consent
- •Non-English speaking
- •Patients with known anatomical malformations of the ureters, bladder, or urethra
研究组 & 干预措施
Amniotic Membrane Therapy
Under general anesthesia, cystoscopy will be performed. A needle will be inserted into the detrusor muscle to a depth of approximately 2 mm. 100mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride, and 0.5 mL of the solution will be injected into 20 equally spaced sites into the posterior and lateral walls of the bladder, sparing the dome and the trigone.
干预措施: Clarix Flo (Drug)
Placebo
Under general anesthesia, cystoscopy will be performed. A needle will be inserted into the detrusor muscle to a depth of approximately 2 mm. 0.5 mL of 10 mL of 0.9% preservative-free sodium chloride will be injected into 20 equally spaced sites into the posterior and lateral walls of the bladder, sparing the dome and the trigone.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Interstitial Cystitis Symptom Index (ICSI) score
时间窗: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Evaluate for clinically-meaningful reduction in symptoms as defined as a 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)
次要结局
- Change in number of urinary tract infections as measured by medical record review(To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively)
- Change in Interstitial Cystitis Symptom Index Questionnaire(To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively)
- Change in Bladder Pain/ Interstitial Cystitis Symptom Score(To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively)
- Change in Interstitial Cystitis Problem Index Questionnaire(To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively)
- Change in Overactive Bladder Assessment Tool Scores(To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively)
- Change in SF-12 Health Survey Scores(To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively)
- Change in Pelvic Pain and Urgency/ Frequency (PUF) Patient Symptom Scale (PUF) Scores(To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively)
研究者
David Sheyn
Physician, UH Hospitals
University Hospitals Cleveland Medical Center