NCT01355133已完成1 期
Transurethral Ultrasound-directed Injection of Autologous Myoblasts in Combination With Functional Electrical Stimulation in Patients With Intrinsic Urinary Sphincter Deficiency
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in Incontinence episode frequency (IEF)
研究概览
简要总结
The purpose of this pilot clinical study is to determine if intrasphincteric autologous myoblast injections in combination with electrical stimulation are safe and effective in treating stress urinary incontinence, confirming the optimal dose and assessing tolerability of the procedure.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female outpatients, predominant clinical diagnosis of SUI
- •Have discrete episodes of incontinence (that is, are dry between episodes and not continuously leaking urine, synchronous with increased intra-abdominal pressure from coughing, sneezing, exercising, etc.)
- •Have a positive Fixed Bladder Volume Cough Stress Test (CST) result; and post void residual volume of <50 ml
- •Report normal urinary diurnal (≤8/day) and nocturnal (≤2/night) frequency per micturition history
- •Have had symptoms of SUI for a minimum of 3 months prior to study entry
- •Can independently use toilet without difficulty
- •If patients regularly use laxatives, stool softeners, or stool-bulking agents (for example, fibre supplements), the use of these products should remain constant during participation in the study.
- •Competent to comprehend, sign, and date an Ethics Committee approved informed consent form before any study-specific procedure is performed.
- •Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrolment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device [IUD], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.
排除标准
- •Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
- •Greater than Stage I Anterior (cystocoele), Apical (uteri), or Posterior (rectocoele) Compartment Prolepses as per the POP-Q)
- •Ureteric bladder, urethral or rectal fistula
- •Uncorrected congenital abnormality leading to urinary incontinence
- •Interstitial cystitis
- •Urinary urgency that results in leakage (as a predominant symptom)
- •Adult enuresis
- •Urodynamically proven:
- •detrusor instability
- •sensory urgency defined as first sensation of bladder fill (urge to void) of <100 ml; bladder capacity of <300 ml
- •voiding difficulty
- •Have no sensation at any time during the simple filling cystometry procedure
- •Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment
- •Have a symptomatic urinary tract infection (UTI); or have a history of four or more urinary tract infections in the preceding year.
- •Have prolonged menstruation (>14 days per month).
- •Have history of (or currently have) urogenital cancer.
- •Suffer from severe constipation defined as less than one bowel movement per week
- •Are pregnant, <12 months postpartum or are lactating
- •Have had any major inpatient surgery within 3 months prior to study entry
- •Known infection with human immunodeficiency virus (HIV)
- •Known active infection with Hepatitis B virus, Hepatitis C virus or Lues.
- •Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
- •Have had any anti-incontinence or prolapse surgery, including the following:
- •Anterior Repair
- •Needle Suspension such as Raz; Pereyra; Stamey; Gittes; and Muzsnai procedures
- •Retropubic Procedures: such as Marshall, Marchetti & Krantz; and Burch procedures
- •Sling Procedure
- •Collagen Injections
- •Artificial Sphincter.
- •Use any of the following:
- •Any anti-incontinence device (for example, Reliance, Minigard, or FemAssist) including tampons used to prevent incontinence during participation in the study
- •Vaginal pessaries for prolapse or incontinence
- •Any nonpharmacologic intervention for incontinence or prolapse (for example, electro stimulation, vaginal cones, or any such device) within the 3 months prior to study entry.
- •Current use of any of the following drugs: antidepressants, duloxetine, monoamine oxidase inhibitors or other, clonidine, alpha-methyl-DOPA, beta-blockers, guanethidine, reserpine, pentosan polysulfate, or alpha-receptor antagonists/agonists (chronic use).
- •Current use of any medications for the treatment of urinary incontinence.
- •Are on a medication regimen including estrogens, anti-estrogens, or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks, or is anticipated to change during the course of the study.
- •≤ 30 days since receiving an investigational medicinal product or device in another clinical trial. Current enrollment in another clinical trial is not permitted.
- •Allergy/ intolerance of at least one of the active ingredients or excipients of the investigational products, e.g. bovine protein, gentamycin
- •Have any abuse disorder within the 5 years prior to study entry; e.g. patients who report regular consumption of >21 alcoholic drinks per week (an average of 3 drinks per day)
结局指标
主要结局
Change from baseline in Incontinence episode frequency (IEF)
时间窗: 6 months post-implantation
The median percent change from baseline in IEF using the 3-day bladder diary analysis
Change from baseline in Quality of Life (I-QOL) total score
时间窗: 6 months post-implantation
Mean improvement from baseline for the Incontinence Quality of Life (I-QOL) total score
Change from baseline in the Incontinence score
时间窗: 6 months post-implantation
次要结局
- Time to onset of response(Up to 6 months post-implantation (based on recordings at baseline, at implantation, at 6 weeks, 3 months and 6 months post-impalntation))
- Change from baseline in Fixed bladder stress test outcome(Baseline, 6 months postimplantation.)
- Rate for subsequent incontinence surgery(6 months post-implantation)
- Change from baseline in Urodynamic evaluation(6 months post-implantation)
- Safety(Up to 6 months post-implantation)
- Change from baseline in Urinary incontinence semiquantitative (UIS)(6 months post-implantation)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
3 期
Transurethral Ultrasound directed Injection of autologous Myoblasts, Fibroblasts and Collagen for the treatment of urinary incontinenceinvoluntary urine lossstress-incontinence1000499410038365NL-OMON29996Innovacell Biotechnologie GmbH25
进行中（未招募）
不适用
Transurethral ultrasound-directed injection of autologous myoblasts in combination with functional electrical stimulation in patients with intrinsic urinary sphincter deficiency.Stress urinary incontinence due to intrinsic sphincter deficiency (ISD).MedDRA version: 9.1Level: LLTClassification code 10066218Term: Stress urinary incontinenceMedDRA version: 9.1Level: PTClassification code 10066218Term: Stress urinary incontinenceEUCTR2009-012389-30-SIniversity Medical Centre Ljubljana, Department of Gynaecology
已完成
1 期
Single Intrasphincteric Injection Of Autologous Adipose-derived Stem Cells To Treat Stress Urinary Incontinence After Radical Prostatectomy: A Pilot StudyJPRN-UMIN000047336Al Zahraa Hospital, Beirut, Lebanon10
Unknown
1 期
Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis)NCT02286011Red de Terapia Celular20
已完成
不适用
Ultrasound-guided IUD Insertion During Family Medicine Residency TrainingIUD Insertion ComplicationNCT05594108University of Saskatchewan40