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

American Medical Systems55 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Incontinence, Stress

Interventions

The AMS Male Transobturator Sling SystemDEVICE

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.

AdVance Male SlingDEVICE

A transobturator sling for the treatment of post-prostatectomy incontinence

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (11)

Century City Docotrs Hospital

Los Angeles, California, United States

University of Colorado Health

Denver, Colorado, United States

The University of Michigan HS

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Procedural Endpoint: Procedure Time From First Incision to Closing.

Characterize procedure time from first incision to closing.

Time frame: During Procedure, Approximately 60 Minutes

Procedural Endpoint: Type of Anesthesia Used

Describe the type of anesthesia used.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: post discharge

Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures

Characterize procedural parameters including the use of tack sutures.

Time frame: During Procedure, Approximately 60 Minutes

Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection

Characterize procedural parameters, including muscle dissection across all participants.

Time frame: During Procedure, Approximately 60 Minutes

Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Subject Satisfaction Endpoint: 1-Hour Pad Weight

Summarize subject satisfaction of 1-hour pad weight for participants.

Time frame: Baseline to 24 month

Subject Satisfaction Endpoint: 24-Hour Pad Weight

Summarize subject satisfaction with 24-hour pad weight across participants.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 6 Weeks post implant to 24 Months

Procedural and Device Complication Rates

Percentage of participants with serious and non-serious adverse events.

Time frame: Procedure to 24 Months Post implant