Trial Outcomes & Findings for Performance Evaluation of the AMS CONTINUUM™ Device (NCT NCT00894933)

NCT ID: NCT00894933

Last Updated: 2018-02-22

Results Overview

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
• Results posted on: 2018-02-22

Participant Flow

Participant milestones

Measure	Continuum Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique. CONTINUUM™: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Overall Study STARTED	33
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Continuum Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique. CONTINUUM™: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Overall Study Lost to Follow-up	2
Overall Study Cancelled Procedure	1
Overall Study Did not meeting incl/excl criteria	1

Baseline Characteristics

Performance Evaluation of the AMS CONTINUUM™ Device

Baseline characteristics by cohort

Measure	Continuum Device n=33 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Age, Continuous	58.6 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants
Body Mass Index	27.3 kg/m2 STANDARD_DEVIATION 3.0 • n=5 Participants
History of smoking	19 Participants n=5 Participants
Prostate size (g) via TRUS	33.7 grams STANDARD_DEVIATION 7.9 • n=5 Participants

PRIMARY outcome

Timeframe: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Population: Subjects in whom device placement was attempted

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Safety - Infection That Requires IV Antibiotics or Re-hospitalization	0 Events

PRIMARY outcome

Timeframe: At Device placement

Population: Subjects in whom device placement was attempted (i.e. treated subjects)

Defined as the establishment of a water-tight anastomosis immediately post-Device placement.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Successful Device Placement Successful	30 Participants
Successful Device Placement Not successful	1 Participants

PRIMARY outcome

Timeframe: 7-21 days post-Device placement

Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)

Outcome measures

Measure	Continuum Device n=30 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement Successful removal at 21 days	29 Participants
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement Device not effective	1 Participants

PRIMARY outcome

Timeframe: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Population: Subjects in whom device placement was attempted

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Safety - Perforation of the Bowel or Bladder	1 Events

PRIMARY outcome

Timeframe: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Population: Subjects in whom device placement was attempted

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Safety - Creation of a False Passage	1 Events

PRIMARY outcome

Timeframe: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Population: Subjects in whom device placement was attempted

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Safety - Urinary Retention Requiring Catheterization Post-Device Removal	0 Events

PRIMARY outcome

Timeframe: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Population: Subjects in whom device placement was attempted

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention	0 Events

PRIMARY outcome

Timeframe: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Population: Subjects in whom device placement was attempted

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention	1 Events

PRIMARY outcome

Timeframe: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Population: Subjects in whom device placement was attempted

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Safety - Bladder Neck Contracture	6 Events

SECONDARY outcome

Timeframe: At Device placement

Population: Subjects in whom device placement was attempted

To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Intraoperative/Postoperative Parameters - Estimated Blood Loss	168.5 cc Standard Deviation 219.6

SECONDARY outcome

Timeframe: 7-10 and 13 - 15 days post-Device placement

Population: Subjects with successful device placement

Outcome measures

Measure	Continuum Device n=30 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts Successful removal at 7 - 10 days	24 Participants
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts Successful removal at 14 days	3 Participants
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts Successful removal at 21 day	2 Participants
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts Disrupted anastomosis requiring surgical intervent	1 Participants

SECONDARY outcome

Timeframe: At Device placement

Population: Subjects in whom device placement was attempted

To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Intraoperative/Postoperative Parameters - Total Device Placement Time	7.4 Minutes Standard Deviation 5.6

SECONDARY outcome

Timeframe: At Device placement

Population: Subjects in whom device placement was attempted

To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.

Outcome measures

Measure	Continuum Device n=31 Participants Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time	142.8 Minutes Standard Deviation 34.3

Adverse Events

Continuum Device

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Continuum Device n=31 participants at risk Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Surgical and medical procedures Excessive bleeding	6.5% 2/31 • Number of events 2 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Bladder Neck Contracture/Outlet Obstruct	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Separation/Disruption of Anastomosis	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Cardiac disorders Syncope	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up

Other adverse events

Measure	Continuum Device n=31 participants at risk Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Renal and urinary disorders Urinary Incontinence - De Novo	80.6% 25/31 • Number of events 26 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
General disorders Pain/Discomfort	38.7% 12/31 • Number of events 12 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
General disorders Pain/Discomfort - Other	32.3% 10/31 • Number of events 13 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Hematuria	19.4% 6/31 • Number of events 8 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Reproductive system and breast disorders Erectile Dysfunction - De Novo	58.1% 18/31 • Number of events 18 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Gastrointestinal disorders Pain/Discomfort - Abdominal	25.8% 8/31 • Number of events 8 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Reproductive system and breast disorders Erectile Dysfunction - Worsening	9.7% 3/31 • Number of events 3 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Infections and infestations Infection	9.7% 3/31 • Number of events 3 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Infections and infestations Urinary Tract Infection (UTI)	9.7% 3/31 • Number of events 3 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Urinary Retention	6.5% 2/31 • Number of events 2 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Dysuria	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders False Passage	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Perforation - Bladder	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Gastrointestinal disorders Nausea	6.5% 2/31 • Number of events 2 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Musculoskeletal and connective tissue disorders Pain/Discomfort - Back	6.5% 2/31 • Number of events 2 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Nocturia	6.5% 2/31 • Number of events 2 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
General disorders Dizziness	3.2% 1/31 • Number of events 2 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Gastrointestinal disorders Abdominal Bloating/Gas	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Gastrointestinal disorders Constipation	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Vascular disorders Fluid Overload (Hypervolemia)	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Gastrointestinal disorders Loss of appetite	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Respiratory, thoracic and mediastinal disorders Actelectasis	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Bladder Spasm	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Clot in catheter	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Disease progession	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
General disorders Hemorrhoid	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Increased Creatinine	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Musculoskeletal and connective tissue disorders Inguinal Hernia	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Kidney Stone	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
General disorders Light Headed	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Eye disorders Tunnel Vision	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Cardiac disorders Vasovagal Reaction	3.2% 1/31 • Number of events 1 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Renal and urinary disorders Bladder Neck Contracture/Outlet Obstruct	16.1% 5/31 • Number of events 5 • Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up

Additional Information

Laura Olson, Clinical Project Manager

American Medical Systems

Phone: 952-930-6428

Email: laura.olson2@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place