Phase
Condition
Enuresis
Urinary Incontinence
Treatment
Placebo
allogeneic mesenchymal stem cells
Clinical Study ID
Ages > 50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Women over 50 years old
Women with a clinical diagnosis of genuine or mixed stress urinary incontinence (SUI) with at least 6 months of evolution. Using the definitions of urinaryincontinence internationally accepted by the ICS (International Continence Society):to. SUI: any involuntary loss of urine, immediately preceded by exertion. b. MixedUI: any involuntary loss of urine, immediately preceded by exertion or anuncontrollable desire to urinate.
The predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort.
Women in whom rehabilitative treatment has failed or patients who refuse to undergorehabilitative or surgical treatment
Patients without active urinary tract infection (negative urine culture) at the timeof recruitment and treatment
Signing of the informed consent form
Exclusion
Exclusion Criteria:
Patients with a medical history of previous surgery for incontinence, prolapse orurological/gynecological/colorectal surgery
Major surgery or serious trauma of the subject in the previous semester
Women with mixed urinary incontinence, with predominant symptoms of urgency
History of high-pressure detrusor overactivity
Present infravesical obstruction, vesico-ureteral reflux or clinical history ofurinary fistula (it will be ruled out depending on the case by urethrocystoscopy,urethrocystography and flowmetry).
Present any malignant neoplasm, unless it is basal cell or squamous cell carcinomaof the skin, or present a history of malignant tumors, unless they have been inremission during the previous 5 years.
Cardiopulmonary disease that, in the opinion of the investigator, is unstable orserious enough to exclude the patient from the study.
Medical or psychiatric illness of any type that, in the opinion of the researcher,may be a reason for exclusion from the study.
History of alcohol or other addictive substance abuse in the 6 months prior toinclusion
Subject's allergy to anesthetics
Study Design
Study Description
Connect with a study center
Hospital Universitario del Henares
Coslada, Madrid 28822
SpainActive - Recruiting
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid 28933
SpainActive - Recruiting
Hospital Universitario Infanta Elena
Valdemoro, Madrid 28342
SpainSite Not Available
Hospital Universitario General de Villalba.
Villalba, Madrid 28400
SpainActive - Recruiting
Fundación Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario Doce de Octubre
Madrid, 28041
SpainActive - Recruiting
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