Urinary Incontinence Clinical Trial
Official title:
Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)
The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment
of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social
continence" at 6 months.
Continence is defined by the average number of pads used per day. The social continence is
defined by (0-1) pad per day
Prospective multicenter randomized controlled trial comparing two parallel arms: the
implantation of an adjustable balloon (experimental arm) versus implantation of an artificial
urinary sphincter AMS800 ™ (control arm), for the treatment of female stress urinary
incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
This research will focus on the assessment of improved continence, quality of life, and
Cost-Effectiveness Analysis.
The tested device ACT ™ device is a prosthesis used to support the bladder neck and proximal
urethra increasing the urethral coaptation and supporting to the bladder neck to prevent
urine leakage at stress.
The medical device AMS 800 ™(control arm) is an implantable device made of silicone elastomer
filled with saline/X-Ray fluid, used in the treatment of stress urinary incontinence related
to ISD. It is designed to restore the natural process of urinary control. The device
simulates normal sphincter function by closing the urethra and allowing the patient to void
according to the patient's will and opening of the device (sub-cutaneous pump).
An inclusion visit will take place between 3 months and 1 month before the date of the
surgery to explain the purpose of the study, the benefits and risks for patients, and
describe the comparative medical devices.
Patients will be randomized before surgery (at D0).
The follow-up will be conducted up to one year, with scheduled visits at M1, M3, M6 and M12.
Secondary endpoints will be assessed during scheduled visits.
The medico-economic assessment will be made during the same follow-up period. This period
will take into account improvement of urinary continence and results reported from the 3rd
month as well as the morbidity and mortality related to the implementation of the medical
device up to 1 year.
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