Posted by on Jan 20, 2019 in Urinary incontinence | 0 comments

In a nutshell

This trial is looking at whether nerve stimulation given in both ankles is more effective than in one ankle in the treatment of urge incontinence. The main outcome to be measured is an improvement in urinary symptoms. This study is taking place in Rhode Island, USA. 

The details

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 (percutaneous tibial nerve stimulation or (PTNS). This works by using electricity to stimulate nerves in one ankle. These nerves affect the muscles of the bladder. 

This study aims to test if PTNS carried out on both ankles can improve urinary symptoms better than PTNS carried out on one ankle. The main outcome to be measured is an improvement in urinary symptoms. 

Who are they looking for?

50 participants are needed for this study. Participants should have tried and failed, or have been unable to tolerate, behavioral therapy.

Participants should not be pregnant. They should not be diagnosed with a neurogenic bladder (bladder dysfunction caused by nerve damage) and should not have pacemakers (electric stimulating device) or other implanted stimulation devices. Participants should not have received Botox. Participants must not have an uncontrolled bleeding disorder or unhealed leg ulcers.

How will it work

Participants will be randomly assigned to one of two groups. Group 1 will receive one injection just above the ankle. Through this needle, they will receive nerve stimulation in one leg. Group 2 will receive two injections just above the ankle. They will receive nerve stimulation in both legs. Stimulation will be carried out for 30 minutes. 

Participants will fill out a questionnaire to assess urinary symptom severity. A diary will be kept by patients. This will record the number of urinations per day, incontinence episodes per day and number of nighttime urinations. 

Clinical trial locations

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Type:Interventional
Participants:50
Study ID:NCT03535857
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