This trial is comparing two types of nerve stimulation in the treatment of urge incontinence. The main outcome to be measured in this trial is a reduction in urgent urination and the occurrence of side effects. This trial is being carried out in California, Florida, Michigan, Nebraska, Ohio, Oklahoma and Texas, USA.
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. Nerve stimulation involves implanting a device which controls the muscles around the bladder. Stimulation is less invasive than surgery.
This trial compares two types of nerve stimulation, tibial nerve stimulation (TNS) and sacral nerve stimulation (SNS). Devices are implanted on two different nerves of the body and the effect of them on urge incontinence is examined. The main outcome to be measured in this trial is a reduction in urgent urination and the occurrence of side effects.
Who are they looking for?
200 patients are needed for this study. To be included in this study, patients must have at least 10 urinations per day and the symptoms should last for at least 6 months. Women must be willing to go on birth control. Patients must have stopped taking anti-incontinence medications for at least 2 weeks before the trial. Patients cannot have an obstruction in their bladder or bladder stones or cancer.
Patients cannot be included in this trial if they have an active implanted device and cannot have used Botox in the previous 9 months. Female patients cannot be less than 1 year after giving birth or breastfeeding. Patients cannot have a history of bleeding disorders or uncontrolled diabetes, and should not be on blood thinners.
How will it work
Patients will be divided into 2 groups. Group 1 will receive tibial nerve stimulation. Group 2 will receive sacral nerve stimulation. Patients will keep urination diaries. Follow-up phone calls will occur at 3, 6 and 12 months. Patients will be assessed for a reduction in the number of urgent episodes and side effects from the stimulation devices.