Clinical Research Directory

Inclusion Criteria: * Adult patients (both women and men) aged between 21 and 85 years * Documented stress urinary incontinence (urethral hypermobility or intrinsic sphincter deficiency) in which urgency symptoms are a minor component of the incontinence symptoms * Stress urinary incontinence present and physiologically stable over the last 6 months. * Urinary leakage \>150 ml in the 24-hour PAD test performed during the pre-implantation screening phasefor male patients.- Urinary leakage \>150 ml in the 24-hour PAD test performed during the pre-implantation screening phase * Cognitive/manual ability to use the device. * The patient is willing and able to meet the requirements of the protocol. * The patient has decided to be implanted with the device for the treatment of urinary incontinence * Willingness to sign the informed consent form. * Willingness to return for follow-up evaluations and complete questionnaires. * The patient has been informed about alternative therapies available for the treatment or management of urinary incontinence and about all possible risks associated with the implantation of the device. * Any pre-existing urological conditions have been treated and resolved or are under control. * Urinalysis and urine culture negative for infections and (micro)hematuria. * Flexible cystoscopy with evidence of sphincter incompetence. Exclusion Criteria: * Primary urge incontinence or mixed stress and urge incontinence in which urge symptoms are a major component of the incontinence symptoms. * Detrusor overactivity. * History of recurrent bladder stones. * Atonic neurogenic bladder or detrusor sphincter dyssynergia. * Patients taking specific medications for bladder dysfunction or currently undergoing treatment for incontinence. * Post-void residual urine \>200 ml. * Maximum cystometric capacity \<150 ml. * Detrusor pressure \>20 cmH2O. * Flexible cystoscopy showing stenosis that prevents device implantation. * History of previously undiagnosed and unidentified microhematuria. * Unexplained cystoscopic abnormalities and any suspected ongoing urological pathology. * Asymptomatic bacteriuria during the screening period. * History of bladder or upper urinary tract infections more than twice in the last 12 months. * Patients requiring frequent catheterization or intermittent cystoscopy due to previous conditions. * Female patients who are pregnant or planning to become pregnant within the next year. * Stage II uterine prolapse in female patients. * Previous pelvic surgery or radiotherapy in female patients. * Any previous implantation of medical devices for urinary incontinence. * History of sensitivity to silicone, titanium, nickel, and all materials listed in the technical data sheet. * Vulnerable patients or those in emergency circumstances. * The patient's health status precludes completion of follow-up, including terminal illnesses. * Not willing/able to comply with the study requirements. * Participation in any clinical study in the last 3 months.