Tiny device inside the body may stop leakage when you cough or sneeze

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.