This trial is looking at the safety and effectiveness of using muscle cells in treating stress urinary incontinence. The main outcome to be measured in this trial is a reduction in the number of urine leaks. This trial is being carried out in Virginia, USA.
The details
Stress incontinence is urine leakage when there is pressure on the bladder. It is often observed when a patient coughs, sneezes or exercises. Stress incontinence happens as a result of weak muscles around the bladder that hold urine in. It can be treated by pelvic floor exercises, drug therapy, pessaries (to support the walls of the bladder), nerve stimulation or surgery. These treatments do not always work. Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) are muscle cells. These muscle cells are being developed to treat stress urinary incontinence. They are injected into the bladder. They should strengthen the weakened muscles around the bladder.
This trial is examining the safety and effectiveness of AMDC-USR compared to a placebo. The main outcome to be measured is a reduction in the number of urine leaks during the 12 month trial period.
Who are they looking for?
320 patients are needed for this trial. To be included in this trial, patients should have stress urinary incontinence symptoms for at least 6 months. Patients must also have completed all of the screening 3-day diary evening reports.
Patients will not be included in the trial if they have more than 2 nighttime urinations. Patients cannot be taking medication which may affect the muscles around the bladder. These include anticholinergics, beta 3 adrenergic receptor agonists, antidepressants, diuretics or alpha-adrenergic blockers. Patients cannot have a history of any cancer in the pelvic organs or kidneys. Patients cannot be pregnant, breastfeeding, or planning to become pregnant during the trial.
How will it work
Patients will be randomly assigned to two groups. Group 1 will receive muscle cell injections. Group 2 will receive placebo injections. Patients will maintain a urination diary for 12 months.
The main outcome to be measured is a reduction in the number of urine leaks during the 12 month trial period.
