Clinical trial NCT01083199: Global Performance Evaluation of the AMS CONTINUUM™ Device
Official title: Global Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Radical Prostatectomy
Vesico-Urethral Anastomosis
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful Device Placement
timeFrame: During Radical Prostatectomy
measure: Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement
timeFrame: 7-21 days post-Device placement
Secondary outcomes:
measure: Intraoperative/Postoperative Parameters
timeFrame: At Device placement
measure: Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits
timeFrame: 7 and 14 days post-Device placement
measure: Incontinence Rate and I-QOL Score
timeFrame: Baseline, 6-week, 6 and 12-month evaluations
measure: Bladder Neck Contracture (BNC) Rate
timeFrame: Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal
Other outcomes:
Locations:
city: Rio-Patras
country: Greece
facility: University of Patras
city: Madrid
country: Spain
facility: Hospital University Gregorio Maranon
Study officials:
affiliation: University of Patras
name: Evangelos Liatsikos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital University Gregorio Maranon
name: Carlos Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: