Multisystem Cell Therapy for Improvement of Urinary Continence (MUSIC)

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Muscle Precursor Cells Read More

Inclusion Criteria:

Adult women 20y-60y

• Incontinence >/= grade I since at least 6 months
• Predominant clinical diagnosis of SUI
• Candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).
• Post void residual volume of <100 ml (exclusion of overflow incontinence)
• Can independently use toilet without difficulty
• Capacity to answer the questionnaires of evaluation
• Negative blood test for: Human immunodeficiency virus (HIV 1/2), Hepatitis B HBsAg, Anti HBc, Hepatitis C Anti-HCV-Ab, Syphilis
• Competent to comprehend, sign and date informed consent form before any study-specific procedure is performed

Exclusion Criteria:

• History of anti-incontinence or prolapse surgery.

• Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:

  • Clinically significant cystocele or rectocele
  • 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
• No sensation at any time during the simple filling cystometry procedure
• Known urethral stenosis (ureterocystoscopy) or urethral diverticulum
• History of urogenital cancer or history of pelvic radiotherapy
• Women who are pregnant, breast feeding or <12 months postpartum Note: Female subjects who are surgically sterilized, hysterectomized or post-menopausal for longer than 2 years are not considered as having child bearing potential. No pregnancy test will be performed for this population.
• Untreated symptomatic urinary tract infection
• Fever (as defined by ≥ 38,5°C, axillar measurement), any infectious disease, cold or flu within the last 7 days
• Unstable severe systemic disease including uncontrolled hypertension, unstable angina, or myocardial infarction, severe coagulation disorders, bleeding diathesis, emboli, thrombophlebitis, infectious diseases, poor wound healing, and poorly controlled diabetes mellitus within 6 months before enrolment
• 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.
• Known allergy or intolerance of at least one of the active ingredients or excipients of the investigational products
• Known allergy or intolerance of Penicillin or Streptomycin
• Known genetically determined or acquired muscular disease.
• Known Neurological disorder (Parkinson's disease, multiple sclerosis, spina bifida, medullary traumatism).
• 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.
• Chronic use of any of the following drugs and not stopped for at least 2 weeks prior to inclusion into the study: selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), alpha-receptor antagonists/agonists, beta-3-receptor agonists or anticholinergic/-muscarinic drugs.
• Chronic use of any of the following drugs and not stopped for at least 6 months prior to inclusion into the study: Antidepressants or neuroleptic drugs.