Urinary Urge Incontinence (UUI) is a condition in which a person experiences the sudden urgent need to urinate with or without unintended urination and the frequent need to urinate during both the day and at night, all of which occur in the absence of other underlying health problems.
miniaturo™-I is a device designed to treat UUI. The device consists of an electronic stimulator and an attached electronic lead, both of which are implanted surgically in the pelvis of UUI sufferers. It is designed to generate electrical impulses that restore the normal electrical activity of pelvic floor muscles that are responsible for maintaining the natural process of bladder control thereby allowing the bladder to fill normally without the patient feeling an urgent need to urinate.
Only women who fail conservative treatment options and are seeking a more permanent means of controlling their symptoms, will be offered participation in this study.
Inlusion Criterior
At least 18 years old. Patient who failed conservative treatments (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy) for at least 6 months. Overactive detrusor demonstrated on cystometry during the last 6 months or patients who are regarded as sensory urgency. Urinary Urge Incontinence greater then 5 episodes per day. Urinary frequency greater than 10 times/day and 3 times/night. Patient is prepared to attend all follow-up evaluations and complete all necessary study tasks.
Exclusion Criteria
Any active implant (cardiac or other). Urinary incontinence surgery or implantation of artificial graft material within the last 6 months. Obvious clinically demonstrated genuine stress incontinence. Severe uncontrolled diabetes. Any severe heart disease. Current pregnancy or attempting to get pregnant. Patient with uncontrolled bleeding coagulopathy.
If you are interested in helping us with our research by taking part in this study, please call Robyn Walsh at the Endo-Gynaecology Department at the Royal Hospital for Women on 0400 88 00 11 or by email
