Prostate Cancer
Conditions
Keywords
Prostate Cancer, Radical Prostatectomy, Vesico-Urethral Anastomosis
Brief summary
1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure. 2. To assess clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy.
Detailed description
Radical prostatectomy (RP) is the most utilized surgical treatment option for localized prostate cancer due to the multi-focal nature of the disease. RP is most suitable for otherwise healthy men whose cancer is limited to a small area. The RP procedure involves removing the prostate gland, seminal vesicles and nearby lymph nodes. One of the most technically challenging and critical aspects in all of these surgical approaches is reconstruction of the interrupted urinary tract by hand sewing the vesico-urethral anastomosis. This is where the bladder neck is sewn to the urethra after the prostate has been removed. CONTINUUM™ (study Device) is to be used as part of the RP procedure by facilitating the approximation of the bladder neck and urethral stump. The Device brings together and holds the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs thereby minimizing extravasation. The Device also provides a conduit for drainage of urine from the bladder out the urethra during tissue healing. The concept of the CONTINUUM™ device and the feasibility of its operation have been successfully tested in animal and human studies. Pilot clinical studies in the United States (G060095) found that the majority of subjects who received and were discharged with the Device demonstrated a water-tight vesico-urethral anastomosis at the first Device removal visit. Additionally, no unanticipated adverse device effects (UADEs) were reported. The focus of the proposed study is to further verify the performance of the Device in global research centers.
Interventions
DEVICECONTINUUM™
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Sponsors
American Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study
Exclusion criteria
* If contraindicated for surgery * Inability to understand the study or a history of non-compliance with medical advice * Unwilling or unable to sign an Informed Consent Form (ICF) * A history of: 1. Recurrent urinary tract infections (UTI) 2. Recurrent stricture disease * Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease) * Uncontrolled insulin-dependent diabetes * Chemotherapy within the past 6 months * Non-topical steroid use within the past 6 months * Allergy to nitinol, nickel, titanium or silicone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Device Placement | During Radical Prostatectomy | Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement. |
| Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement | 7-21 days post-Device placement | Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window. The following defines the timeframe of each removal attempt: * 7-day window (7-10 days post-implant) * 14-day window (13-15 days post-implant) * 21-day window (19-21 days post-implant) |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative/Postoperative Parameters | At Device placement |
| Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits | 7 and 14 days post-Device placement |
| Incontinence Rate and I-QOL Score | Baseline, 6-week, 6 and 12-month evaluations |
| Bladder Neck Contracture (BNC) Rate | Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal |
Countries
Greece, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AMS CONTINUUM™ Device | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | AMS CONTINUUM™ Device |
|---|---|
| Age, Continuous | 64.7 Years STANDARD_DEVIATION 7.9 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 10 |
| serious Total, serious adverse events | 6 / 10 |
Outcome results
Primary
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement
Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window. The following defines the timeframe of each removal attempt: * 7-day window (7-10 days post-implant) * 14-day window (13-15 days post-implant) * 21-day window (19-21 days post-implant)
Time frame: 7-21 days post-Device placement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement | 10 participants with device removal by 21d |
Primary
Successful Device Placement
Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.
Time frame: During Radical Prostatectomy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Successful Device Placement | 10 participants |
Secondary
Bladder Neck Contracture (BNC) Rate
Time frame: Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal
Secondary
Incontinence Rate and I-QOL Score
Time frame: Baseline, 6-week, 6 and 12-month evaluations
Secondary
Intraoperative/Postoperative Parameters
Time frame: At Device placement
Secondary
Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits
Time frame: 7 and 14 days post-Device placement