This trial evaluates nerve stimulation as a treatment for urge incontinence in patients with overactive bladder. The main outcome to be measured is the change in urgent urination episodes. This trial is taking place in the United States.
The details
Overactive bladder (OAB) involves numerous urinary symptoms, including urge incontinence. Urge incontinence is a sudden and strong need to urinate with urine leakage. It can have a negative impact on quality of life. It can occur more often in women. Medications can be taken to calm the muscles and nerves which cause this condition. Medication is not effective for everyone. Surgery is also another possible treatment. Surgery, however, can carry risks and is invasive.
Another treatment option for patients with urge incontinence is nerve stimulation (tibial nerve stimulation). This works by using electricity to stimulate nerves in one ankle. These nerves affect the muscles of the bladder. eCoin is a device for carrying out tibial nerve stimulation. This study is evaluating the safety and effectiveness of eCoin for OAB with urge incontinence. The main outcome to be measured is a change in the number of urgent urinations.
Who are they looking for?
120 patients are needed for this trial. Patients must have a diagnosis of OAB with urge incontinence for at least 6 months. Patients must be intolerant or show a decreased response to anticholinergic medication.
Patients will not be included in the trial if they have stress urinary incontinence or mixed urinary incontinence where stress incontinence is dominant. Patients cannot have a clinically significant bladder outlet obstruction or pelvic organ prolapse. Patients cannot have inflammation, infection or broken skin on either of their lower legs.
How will it work
All patients will receive the eCoin tibial nerve stimulation under the skin. Patients will record urge incontinence episodes in a 3-day diary 12 weeks after the activation of the device. Treatment will continue for between 48 and 52 weeks. Side effects will also be evaluated.
