Clinical trial NCT00904969: A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Official title: A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 55
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: 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.

Eligibility criteria: Inclusion Criteria:

1. The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
2. The subject is willing and able to give valid informed consent.
3. The subject is \> 40 years of age.
4. The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
5. 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.
6. Internal sphincter contractility confirmed by endoscopic view.
7. The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
8. Pre-existing urological conditions, other than incontinence have been treated and are under control.
9. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
10. The subject is a good surgical candidate.

Exclusion Criteria:

1. The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
2. The subject has an atonic bladder.
3. The subject has a post-void residual \> 75 cc.
4. The subject has detrusor-external sphincter dyssynergia.
5. The subject has a urinary tract infection (UTI).
6. The subject was treated with pelvic radiation within the last 6 months.
7. The subject currently has an inflatable penile prosthesis.
8. The subject self-catheterizes.
9. The subject has symptomatic or unstable bladder neck stricture disease.
10. The subject has a history of urethral strictures that may require repetitive instrumentation.
11. 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).
12. The subject has a history of connective tissue or autoimmune conditions.
13. The subject has a compromised immune system.
14. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
15. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Primary outcomes:
measure: Procedural Endpoint: Procedure Time From First Incision to Closing.
timeFrame: During Procedure, Approximately 60 Minutes
measure: Procedural Endpoint: Type of Anesthesia Used
timeFrame: During Procedure, Approximately 60 Minutes
measure: Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative
timeFrame: During Procedure, Approximately 60 Minutes
measure: Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
timeFrame: post-operative to discharge
measure: Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge
timeFrame: post discharge
measure: Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures
timeFrame: During Procedure, Approximately 60 Minutes
measure: Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection
timeFrame: During Procedure, Approximately 60 Minutes
measure: Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning
timeFrame: During Procedure, Approximately 60 Minutes
measure: Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively
timeFrame: During Procedure, Approximately 60 Minutes
Secondary outcomes:
measure: Subject Satisfaction Endpoint: 1-Hour Pad Weight
timeFrame: Baseline to 24 month
measure: Subject Satisfaction Endpoint: 24-Hour Pad Weight
timeFrame: Baseline to 24 month
measure: 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)
timeFrame: Baseline to 24 month
measure: 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)
timeFrame: Baseline to 24 Month
measure: Subject Satisfaction Endpoint: Pads Per Day Use
timeFrame: Baseline to 24 Months
measure: Subject Satisfaction Endpoint: Quality of Life I-QOL Scores
timeFrame: Baseline to 24 Months
measure: Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores
timeFrame: Baseline to 24 Months
measure: Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores
timeFrame: Baseline to 24 Months
measure: Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status
timeFrame: 6 Weeks post implant to 24 Months
measure: Procedural and Device Complication Rates
timeFrame: Procedure to 24 Months Post implant
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Century City Docotrs Hospital
state: California
city: Denver
country: United States
facility: University of Colorado Health
state: Colorado
city: Ann Arbor
country: United States
facility: The University of Michigan HS
state: Michigan
city: Charlotte
country: United States
facility: CHCS - Carolinas Medical Center
state: North Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Centennial Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Christus Santa Rosa Hospital
state: Texas
city: Norfolk
country: United States
facility: Norfolk General
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Chicago Hospital
name: Gregory Bales, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Timothy Boone, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Century City Doctors Hospital
name: Karyn Eilber, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Health
name: Brian J. Flynn, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Michael Guralnick, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Sender Herschorn, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRISTUS Health
name: LeRoy Jones, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Norfolk General
name: Gerald Jordan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHCS - Carolinas Medical Center
name: Michael Kennelly, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centennial Hospital
name: Dean L. Knoll, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Michigan HS
name: Edward McGuire, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolina Urologic Research Center
name: Brian Roberts, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: George D. Webster, M.D.
role: PRINCIPAL_INVESTIGATOR
References: