A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Number of Participants That Experienced Biopsy Procedure-related Adverse Events
研究概览
简要总结
The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •SUI with normal detrusor activity confirmed with urodynamics
- •Bladder capacity >200 ml
- •Incontinence has not shown any improvement for at least -6 months
- •Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
排除标准
- •Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
- •Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
- •Uncontrolled diabetes
- •Pregnant, lactating, or plans to become pregnant during course of the study
- •Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
- •Current or acute conditions involving cystitis or urethritis
- •Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures
结局指标
主要结局
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
时间窗: at biopsy or between biopsy and treatment, approximately 6 weeks
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.
Injection Procedure-related Adverse Events
时间窗: 30 days
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Number of Participants That Experienced AMDC Product-related Events
时间窗: 12 months
If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product. No adverse events reported during the study were adjudicated as AMDC product-related.
Number of Participants That Experienced Injection Procedure-related Adverse Events
时间窗: 30 days
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
次要结局
未报告次要终点