Transurethral ultrasound-directed injection of autologous myoblasts in combination with functional electrical stimulation in patients with intrinsic urinary sphincter deficiency.
- Conditions
- 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 incontinence
- Registration Number
- EUCTR2009-012389-30-SI
- Lead Sponsor
- niversity Medical Centre Ljubljana, Department of Gynaecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
•Female outpatients, =18 and =75 years of age, with predominant clinical diagnosis of SUI due to intrinsic sphincter deficiency
•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
•To meet stratification criteria: report an average of =10 to < 20 or =20 incontinent episodes/week per micturition history collected at Visit 2 with at least one daily incontinent episode
•Report normal urinary diurnal (=8/day) and nocturnal (=2/night) frequency per micturition history collected at Visit 2
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
a) Greater than Stage I Anterior (cystocoele), Apical (uteri), or Posterior (rectocoele) Compartment Prolepses as per the POP-Q)
b) Ureteric bladder, urethral or rectal fistula
c) Uncorrected congenital abnormality leading to urinary incontinence
d) Interstitial cystitis
e) Urinary urgency that results in leakage (as a predominant symptom)
f) Adult enuresis
g) 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) between Visit 1 and 3; 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:
a) Anterior Repair
b) Needle Suspension such as Raz; Pereyra; Stamey; Gittes; and Muzsnai procedures
c) Retropubic Procedures: such as Marshall, Marchetti & Krantz; and Burch procedures
d) Sling Procedure
e) Collagen Injections
f) Artificial Sphincter.
•Use any of the following:
a) Any anti-incontinence device (for example, Reliance, Minigard, or FemAssist) including tampons used to prevent incontinence during participation in the study
b) Vaginal pessaries for prolapse or incontinence
c) 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. (‘Investigational’ is defined as any drug or device not approved for any indication by the applicable regulatory agency). 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of autologous myoblasts;Secondary Objective: Confirmation of the optimal dose. Safety and tolerability of autologous myoblasts.;Primary end point(s): To evaluate the efficacy of autologous myoblasts<br><br>There are two primary efficacy measures: <br>•mean improvement from baseline to endpoint for the Incontinence Quality of Life (I-QOL) total score<br>•the median percent change from baseline to endpoint in incontinence episode frequency (IEF) per week using the last 3-day diary analysis<br>
- Secondary Outcome Measures
Name Time Method