Pelvital Stress Urinary Incontinence Training Device: P-SUIT

120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects will conduct their respective therapy five minutes a day over the course of six weeks. At weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all patients in the control arm will have the option to cross over into the treatment arm if no improvement in symptoms has been shown.

Inclusion criteria

• Female gender,
• Ages 18-75,
• Clinical diagnosis of stress urinary incontinence,
• Ability to contract the pelvic floor muscles,
• Able to document incontinence and voiding in a diary,
• Provision of written informed consent form,
• Minimum of 10 grams increase at initial 24-hour pad weight test

Exclusion criteria

• Diagnosed mixed or urge urinary incontinence,
• Impaired cognitive function or neurologic conditions
• Physical limitations that impede the patient's ability to participate (e.g., ability to stand),
• Acute infections or hematuria,
• Pregnant or actively trying to conceive,
• History of pelvic irradiation,
• Concurrent medications with α-adrenergic antagonists or diuretics
• Pelvic organ prolapse stage III or IV,
• Severe urethral sphincter weakness and/or defect,
• Suspected urethral and/or vesical fistula