Urinary Incontinence Clinical Trial
Official title:
A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.
The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To
date, there is an increasing use in the clinical practice of new techniques for the
treatment of this condition and several surgical devices, characterized by minimally
invasive approach, are commercialized.
Recently, single-incision devices have been proposed. One of the most relevant potential
advantages of these devices is the possibility of performing their positioning under local
anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly
useful in two subgroups of patients with urinary incontinence, i.e. women with genuine
stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress
incontinence raised after surgical correction of (severe) POP.
Poor data coming from randomized controlled trials (RCTs) are available regarding
single-incision devices for the treatment of stress incontinence, and there are no
conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no
randomized controlled trial is actually available in literature comparing different
single-incision devices.
Women with genuine urinary stress incontinence not associated with POP will be enrolled and
randomized in three groups (arm 1, arm 2 and arm 3). All patients eligible will undergo
baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and
urodynamic evaluations. At time of surgery, all patients will be randomized in three
surgical treatment groups (arm 1, 2 and 3). Patients of arm 1 will be treated with
positioning of Ajust (Bard Urological Division, Covington, GA, USA), patients of group 2
will be treated with positioning of MiniArc (AMS, Minnetonka, MN, USA) and patients of arm 3
will be treated with positioning of TVT Secur System (Ethicon, Somerville, NJ, USA).
During the study, the clinical outcomes, and the adverse experience will be evaluated in
each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less
will be considered significant.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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