Back to resultsA Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence (AMS051)
Primary Purpose
Urinary Incontinence, Stress
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
The AMS Male Transobturator Sling System
AdVance Male Sling
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, Transurethral Resection (TUR), Transurethral Resection of the Prostate (TURP), Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy
Eligibility Criteria
Inclusion Criteria:
- The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
- The subject is willing and able to give valid informed consent.
- The subject is > 40 years of age.
- The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
- The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
- Internal sphincter contractility confirmed by endoscopic view.
- The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
- Pre-existing urological conditions, other than incontinence have been treated and are under control.
- The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
- The subject is a good surgical candidate.
Exclusion Criteria:
- The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
- The subject has an atonic bladder.
- The subject has a post-void residual > 75 cc.
- The subject has detrusor-external sphincter dyssynergia.
- The subject has a urinary tract infection (UTI).
- The subject was treated with pelvic radiation within the last 6 months.
- The subject currently has an inflatable penile prosthesis.
- The subject self-catheterizes.
- The subject has symptomatic or unstable bladder neck stricture disease.
- The subject has a history of urethral strictures that may require repetitive instrumentation.
- The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
- The subject has a history of connective tissue or autoimmune conditions.
- The subject has a compromised immune system.
- The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
- The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.
Sites / Locations
- Century City Docotrs Hospital
- University of Colorado Health
- The University of Michigan HS
- CHCS - Carolinas Medical Center
- Carolina Urologic Research Center
- Centennial Hospital
- Baylor College of Medicine
- Christus Santa Rosa Hospital
- Norfolk General
- Medical College of Wisconsin
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AMS Transobturator Male Sling System
Arm Description
Outcomes
Primary Outcome Measures
Procedural Endpoint: Procedure Time From First Incision to Closing.
Characterize procedure time from first incision to closing.
Procedural Endpoint: Type of Anesthesia Used
Describe the type of anesthesia used.
Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative
Number of participants requiring the use of a foley catheter intra-operatively.
Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
Number of participants requiring the use of a foley catheter who were able to void prior to discharge.
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge
Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures
Characterize procedural parameters including the use of tack sutures.
Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection
Characterize procedural parameters, including muscle dissection across all participants.
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning
Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.
Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively
Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.
Secondary Outcome Measures
Subject Satisfaction Endpoint: 1-Hour Pad Weight
Summarize subject satisfaction of 1-hour pad weight for participants.
Subject Satisfaction Endpoint: 24-Hour Pad Weight
Summarize subject satisfaction with 24-hour pad weight across participants.
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)
Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)
Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).
Subject Satisfaction Endpoint: Pads Per Day Use
Summarize the subject satisfaction using pads per day use collected in follow-up in participants.
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores
The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores
The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores
Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status
Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations
Procedural and Device Complication Rates
Percentage of participants with serious and non-serious adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00904969
Brief Title
A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Acronym
AMS051
Official Title
A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Medical Systems
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.
Detailed Description
A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected.
Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.
Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, Transurethral Resection (TUR), Transurethral Resection of the Prostate (TURP), Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMS Transobturator Male Sling System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
The AMS Male Transobturator Sling System
Intervention Description
The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
Intervention Type
Device
Intervention Name(s)
AdVance Male Sling
Other Intervention Name(s)
Male TO, transobturator sling, suburethral sling, retrourethral sling
Intervention Description
A transobturator sling for the treatment of post-prostatectomy incontinence
Primary Outcome Measure Information:
Title
Procedural Endpoint: Procedure Time From First Incision to Closing.
Description
Characterize procedure time from first incision to closing.
Time Frame
During Procedure, Approximately 60 Minutes
Title
Procedural Endpoint: Type of Anesthesia Used
Description
Describe the type of anesthesia used.
Time Frame
During Procedure, Approximately 60 Minutes
Title
Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative
Description
Number of participants requiring the use of a foley catheter intra-operatively.
Time Frame
During Procedure, Approximately 60 Minutes
Title
Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
Description
Number of participants requiring the use of a foley catheter who were able to void prior to discharge.
Time Frame
post-operative to discharge
Title
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge
Description
Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.
Time Frame
post discharge
Title
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures
Description
Characterize procedural parameters including the use of tack sutures.
Time Frame
During Procedure, Approximately 60 Minutes
Title
Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection
Description
Characterize procedural parameters, including muscle dissection across all participants.
Time Frame
During Procedure, Approximately 60 Minutes
Title
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning
Description
Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.
Time Frame
During Procedure, Approximately 60 Minutes
Title
Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively
Description
Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.
Time Frame
During Procedure, Approximately 60 Minutes
Secondary Outcome Measure Information:
Title
Subject Satisfaction Endpoint: 1-Hour Pad Weight
Description
Summarize subject satisfaction of 1-hour pad weight for participants.
Time Frame
Baseline to 24 month
Title
Subject Satisfaction Endpoint: 24-Hour Pad Weight
Description
Summarize subject satisfaction with 24-hour pad weight across participants.
Time Frame
Baseline to 24 month
Title
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)
Description
Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).
Time Frame
Baseline to 24 month
Title
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)
Description
Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).
Time Frame
Baseline to 24 Month
Title
Subject Satisfaction Endpoint: Pads Per Day Use
Description
Summarize the subject satisfaction using pads per day use collected in follow-up in participants.
Time Frame
Baseline to 24 Months
Title
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores
Description
The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.
Time Frame
Baseline to 24 Months
Title
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores
Description
The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.
Time Frame
Baseline to 24 Months
Title
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores
Description
Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.
Time Frame
Baseline to 24 Months
Title
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status
Description
Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations
Time Frame
6 Weeks post implant to 24 Months
Title
Procedural and Device Complication Rates
Description
Percentage of participants with serious and non-serious adverse events.
Time Frame
Procedure to 24 Months Post implant
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
The subject is willing and able to give valid informed consent.
The subject is > 40 years of age.
The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
Internal sphincter contractility confirmed by endoscopic view.
The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
Pre-existing urological conditions, other than incontinence have been treated and are under control.
The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
The subject is a good surgical candidate.
Exclusion Criteria:
The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
The subject has an atonic bladder.
The subject has a post-void residual > 75 cc.
The subject has detrusor-external sphincter dyssynergia.
The subject has a urinary tract infection (UTI).
The subject was treated with pelvic radiation within the last 6 months.
The subject currently has an inflatable penile prosthesis.
The subject self-catheterizes.
The subject has symptomatic or unstable bladder neck stricture disease.
The subject has a history of urethral strictures that may require repetitive instrumentation.
The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
The subject has a history of connective tissue or autoimmune conditions.
The subject has a compromised immune system.
The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Bales, M.D.
Organizational Affiliation
University of Chicago Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Boone, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karyn Eilber, M.D.
Organizational Affiliation
Century City Doctors Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian J. Flynn, M.D.
Organizational Affiliation
University of Colorado Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Guralnick, M.D.
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sender Herschorn, M.D.
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LeRoy Jones, M.D.
Organizational Affiliation
CHRISTUS Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerald Jordan, M.D.
Organizational Affiliation
Norfolk General
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Kennelly, M.D.
Organizational Affiliation
CHCS - Carolinas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dean L. Knoll, M.D.
Organizational Affiliation
Centennial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward McGuire, M.D.
Organizational Affiliation
The University of Michigan HS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Roberts, M.D.
Organizational Affiliation
Carolina Urologic Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George D. Webster, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Century City Docotrs Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
University of Colorado Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
The University of Michigan HS
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
CHCS - Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Centennial Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Christus Santa Rosa Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Norfolk General
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data generated from this study may be used to support clinical publications, internal device documents for marketing and/or instructional manuals, etc.
Learn more about this trial
A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
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