In a nutshell
This study aimed to investigate the long-term safety and effectiveness of a surgical implant called the ProACT, on stress urinary incontinence after prostate cancer surgery. This study found that this implant led to significant improvements in quality of life in these patients.
Some background
Stress urinary incontinence (SUI) is the unintentional loss of urine due to stress put on the bladder. This stress can result from sneezing or exercising. This is a common side-effect of surgery to remove the prostate gland in patients with prostate cancer. SUI can lead to a decreased quality of life.
The adjustable ProACT device is one treatment option for SUI. This device consists of two small, adjustable balloons connected through short tubes to an injection port. The balloon devices are inserted on each side of the urethra through a minimally invasive outpatient procedure. The fluid-filled balloons put pressure on the bladder and help to stop urine from leaking out. The long-term effects of this implant are unclear.
Methods & findings
68 patients who had a ProACT device implanted were included in this trial. They were followed up for 4 years. They were followed up using questionnaires examining their quality of life, urinary function or side-effects from the surgery.
Patients using the implant could retain more urine in their bladder. The average urine loss before the implant was 293g. This was reduced to 73g at 4 years. Patients also reported improvements in their quality of life.
75.9% of the patients with mild SUI had significant improvements in urinary symptoms (a more than 50% reduction in urine leakage) at 4 years after the implant. 82.6% of the group with moderate SUI and 87.5% of those with severe SUI reported significant improvements in urinary symptoms.
Most side effects were mild and easily managed. Only one patient experienced urine retention that required overnight hospitalization over 4 years.
The bottom line
This study found that the ProACT device led to significant improvements in quality of life in patients who have stress urinary incontinence after prostate removal surgery.
The fine print
This study was funded by Uromedica, Inc., the manufacturer of the ProACT device.
What’s next?
Consult with your doctor If you have any concerns regarding involuntary loss of urine.
Published By :
Neurourology and urodynamics
Date :
Oct 12, 2018