INJECTABLE BULKING AGENT FOR MALE URINARY INCONTINENCE TREATMENT: A MULTI-CENTRE EFFECTIVENESS AND SAFETY PILOT STUDY

The investigational device Opsys is a permanent-action and definitive tissue
bulking non-absorbable substance suitable to treat male and female Stress
Urinary Incontinence (SUI). It consists of particles of polyacrylate
polyalcohol copolymer (PPC) immersed in a glycerol and physiological solution
carrier. It has a very high molecular mass and it comes in the form of sterile
pyrogen-free particles that are flexible and highly deformable by compression.
When injected in soft tissue, the carrier is eliminated by the
reticuloendothelial system without metabolizing and excreted through the
kidneys. The macroparticles stay, enlarging the volume of the tissue generating
a minimum fibrotic growth around them, producing tissue bulkiness that remains
stable throughout time. Opsys produces urethral coaptation, given the bulkiness
effect on the urethral submucosa, restoring urinary continence. This bulking
agent is to be used only in accordance with this approved Clinical
Investigational Plan on subjects who have signed an informed consent form.
Device use is limited to the approved study investigators.

Hypothesis: Opsys will improve mild incontinence based on urine loss per 24 h
measured by 24 h pad test.
The main objective of this study is to test the effectiveness of Opsys in a
group of selected subjects with minimal to mild (less than 30 g per day urine
loss on 24 h pad weight test) post-radical prostatectomy SUI.
The secondary goals that this study pursues are:
* Quality of life assessment regarding their post-implantation condition.
* Usage of fewer pads per day.
* Frequency of expected adverse events.
* To assess the surgical technique regarding the optimal volume injected and
injection sites.
* To evaluate safety endpoints.

This is a post market, prospective, open label, and non-comparative pilot study
involving male adult subjects. This is an unmasked study where subjects and
surgeons are not blind to the procedure.

Opsys will be implanted using a video endoscope with a transurethral injection
needle.

Anticipated clinical benefits
In SUI - ISD treatment, Opsys is transurethrally implanted around the sphincter
area of the urethra to achieve the coaptation of the urethra during storage
phase and maintenance of that coaptation during periods of increased abdominal
pressure. Consequently, anticipated clinical benefits expected with the use of
Opsys are to achieve subject continence.

Anticipated adverse device effects - possible complications
Opsys components have been designed to be used only once. Therefore, it cannot
be reuse or resterilize, as this can potentially result in compromised device
performance and increased risk of inappropriate resterilization and cross
contamination.
The possible complications regarding the use of Opsys must be discussed with
the subject prior to surgery. Complications regarding the implantation of an
injectable agent include those common to these types of procedures:
* Dysuria
* Urinary infection
* Haematuria
* Voiding pain and pain in injection site
* Acute urinary retention
* Long-term adverse effects with low probability of occurrence: urinary
retention, abscess formation, fibrosis, migration and necrosis.
Excessive repair could lead to urinary retention or inability to urinate. If
urinary retention occurs within the immediate period following implant surgery,
a catheterization should be performed using a 12-Fr catheter, or preferably
smaller, until normal urination is restored. Usual precautions regarding
catheter handling and insertion must be taken in order to prevent infection.
As with all implants, existing infection could be exacerbated by Opsys.

It is important to remark that there is not any additional risk or benefit for
subjects who will participate in this study in terms of neither the
investigational device nor the clinical investigation per se in comparison to
those regular patients who will undergo a surgery with Opsys (i.e. out of the
study).
There is no difference between the bulking agent which will be used in this
study and the bulking agent (both named Opsys) available in the market. Regular
Opsys will be delivered to investigational centres to be used as
investigational devices. In other words, the investigational devices will be
manufactured by the same materials and processes as the ones approved for
commercialization, so they will share the same characteristics and properties.
The lack of any differences between investigational devices and those
commercially available justify the absence of any additional risk, in terms of
the device