Urinary Incontinence Research & Clinical Trials

Subject is a male of at least 50 years of age

Subject demonstrates stress urinary incontinence

Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery

Subject is willing and able to undergo surgical implantation of ProACT devices

Existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy

Prostate surgery or any anti-incontinence surgery within the last 12 months

Artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo

Untreated or unsuccessfully treated detrusor instability or over-activity

Radiation therapy in the prostatic area within the last 12 months

Atonic bladder has had or currently has bladder cancer

Detrusor sphincter dyssynergia

Adults above 18 years old with daily UUI with a predominantly urgency component.

All subjects must be intolerant of, or show an inadequate response to, at least one second or third-line therapy, i.e., drug or peripheral nerve percutaneous neurostimulation, prior to enrollment.

Subjects should be appropriate for eCoin therapy based on the US-FDA approved IFU requirements.

Patients with neurogenic lower urinary tract dysfunction, abnormal post-void residual, recent anti-stress incontinence operation, bladder pain syndrome, peripheral neuropathy, lower leg varicosities, venous insufficiency with skin changes or pitting edema near the ankle, or peripheral arterial disease.

OAB medications should be washed out at least two weeks prior to baseline while prior percutaneous tibial nerve stimulation (PTNS) and onabotulinumtoxin A patients should have washout periods of one and nine months respectively.