- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01355133
Safety and Efficacy Study of Intrasphincteric Autologous Myoblast Injection to Treat Stress Urinary Incontinence
Transurethral Ultrasound-directed Injection of Autologous Myoblasts in Combination With Functional Electrical Stimulation in Patients With Intrinsic Urinary Sphincter Deficiency
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Ljubljana, Eslovenia, 1000
- University Medical Center Ljubljana, Dept. of Gynecology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in Incontinence episode frequency (IEF)
Periodo de tiempo: 6 months post-implantation
|
The median percent change from baseline in IEF using the 3-day bladder diary analysis
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6 months post-implantation
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Change from baseline in Quality of Life (I-QOL) total score
Periodo de tiempo: 6 months post-implantation
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Mean improvement from baseline for the Incontinence Quality of Life (I-QOL) total score
|
6 months post-implantation
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Change from baseline in the Incontinence score
Periodo de tiempo: 6 months post-implantation
|
6 months post-implantation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to onset of response
Periodo de tiempo: Up to 6 months post-implantation (based on recordings at baseline, at implantation, at 6 weeks, 3 months and 6 months post-impalntation)
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Time to onset of response; time to maximum response; maintenance of response observed through changes in Incontinence episode frequency(IEF), Visual analog scale of the degree of suffering (VAS), Modified patient global impression of improvement(PGI-I*), fixed bladder stress test and I-QOL.
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Up to 6 months post-implantation (based on recordings at baseline, at implantation, at 6 weeks, 3 months and 6 months post-impalntation)
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Change from baseline in Fixed bladder stress test outcome
Periodo de tiempo: Baseline, 6 months postimplantation.
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Baseline, 6 months postimplantation.
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Rate for subsequent incontinence surgery
Periodo de tiempo: 6 months post-implantation
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6 months post-implantation
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Change from baseline in Urodynamic evaluation
Periodo de tiempo: 6 months post-implantation
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Cystometry, urethral pressure profile (UPP), 1-hour pad-test.
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6 months post-implantation
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Safety
Periodo de tiempo: Up to 6 months post-implantation
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Number of adverse events, patholgical lab values, vital signs and weight recordings. Number of immediate and delayed complications of cell injection, including surgical injury, scars, urinary tract infection, inflammation, pelvic pain, prolonged urinary retention, voiding dysfunction, de novo urge incontinence, hematuria, hyperplasia or tumours. Any clinically significant findings based on physical examination, standard haematology, clinical chemistry and urinalysis profiles, Electrocardiogram (ECG), Blood Pressure (BP), pulse rate and adverse events recordings. |
Up to 6 months post-implantation
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Change from baseline in Urinary incontinence semiquantitative (UIS)
Periodo de tiempo: 6 months post-implantation
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Amount of leaked urine measured semiqantitative from a 3-day bladder diary.
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6 months post-implantation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Myoblast/ISD/EKS01
- 2009-012389-30 (Número EudraCT)
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