A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Device: The AMS Male Transobturator Sling System
* Device: AdVance Male Sling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMS Transobturator Male Sling System<br> | Device: The AMS Male Transobturator Sling System<br>* 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.<br>Device: AdVance Male Sling<br>* A transobturator sling for the treatment of post-prostatectomy incontinence<br>* Other names: retrourethral sling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Endpoint: Procedure Time From First Incision to Closing. | Characterize procedure time from first incision to closing. | During Procedure, Approximately 60 Minutes | 
| Procedural Endpoint: Type of Anesthesia Used | Describe the type of anesthesia used. | During Procedure, Approximately 60 Minutes | 
| Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative | Number of participants requiring the use of a foley catheter intra-operatively. | During Procedure, Approximately 60 Minutes | 
| 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. | post-operative 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. | post discharge | 
| Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures | Characterize procedural parameters including the use of tack sutures. | During Procedure, Approximately 60 Minutes | 
| Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection | Characterize procedural parameters, including muscle dissection across all participants. | During Procedure, Approximately 60 Minutes | 
| 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. | During Procedure, Approximately 60 Minutes | 
| 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. | During Procedure, Approximately 60 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction Endpoint: 1-Hour Pad Weight | Summarize subject satisfaction of 1-hour pad weight for participants. | Baseline to 24 month | 
| Subject Satisfaction Endpoint: 24-Hour Pad Weight | Summarize subject satisfaction with 24-hour pad weight across participants. | Baseline to 24 month | 
| 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). | Baseline to 24 month | 
| 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). | Baseline to 24 Month | 
| Subject Satisfaction Endpoint: Pads Per Day Use | Summarize the subject satisfaction using pads per day use collected in follow-up in participants. | Baseline to 24 Months | 
| 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. | Baseline to 24 Months | 
| 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. | Baseline to 24 Months | 
| 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. | Baseline to 24 Months | 
| 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 | 6 Weeks post implant to 24 Months | 
| Procedural and Device Complication Rates | Percentage of participants with serious and non-serious adverse events. | Procedure to 24 Months Post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, Transurethral Resection (TUR), Transurethral Resection of the Prostate (TURP), Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy