Female Stress Urinary Incontinence Clinical Study
Adjustable Continence Therapy for Women (ACT)
The trial for the Adjustable Continence Therapy for Women (ACT) is an investigative treatment option for women suffering from stress urinary incontinence. The procedure is minimally invasive and involves the implant of two silicone balloons on either side of the urethra near the bladder neck. The balloons provide pressure and support to the muscles preventing urine loss. The study doctor may increase the volume of the balloon in an office setting to meet your individual needs.
The ACT clinical trial may be right for you if:
+ You've been diagnosed with stress urinary incontinence with primary intrinsic sphincter deficiency
+ You've failed at least six months of previous conservative (e.g. pelvic floor muscle exercises) or surgical treatment(s) for stress urinary incontinence
+ You can undergo implant surgery
+ You are not currently pregnant or planning on becoming pregnant
+ You do not have uncontrolled diabetes
WHAT IS STRESS URINARY INCONTINENCE (SUI)?
Stress urinary incontinence is the involuntary leakage of urine during physical strain such as coughing, sneezing, or other activity. This condition may arise from intrinsic sphincter deficiency. Intrinsic sphincter deficiency is the weakening of the muscles that prevent unwanted urine loss during physical activity.
WHAT IS ACT?
The procedure is minimally invasive and involves the implant of
two silicone balloons on either side of the urethra near the bladder neck. The balloons provide pressure and support to the muscles preventing urine loss.
The ports are placed just below the skin in your labia to allow your physician to adjust the balloon in the office to meet your individual needs. The device adjustments change the volume of fluid in the balloons providing additional support.
Adjustments to the balloons can begin six weeks after your procedure and can be made every four weeks following until you are dry. Up to 8mL of fluid can be placed in each balloon.
FIND A CLINICAL STUDY LOCATION
Locate an ACT Clinical Trial Location near you!