A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998790
Recruitment Status : Unknown
Verified March 2011 by American Medical Systems.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2009
Last Update Posted : April 1, 2011
Information provided by:
American Medical Systems

Brief Summary:
A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. 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. This study is not designed to statistically demonstrate safety and efficacy of the device.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Device: American Medical Systems (AMS) AdVance™ Male Sling System Phase 4

Detailed Description:

A prospective, 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 Questionaire). Intra-operative procedural data will be collected.

Pad weight and incontinence severity rating (using the ICIQ survey) 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  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
Study Start Date : January 2007
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: American Medical Systems (AMS) AdVance™ Male Sling System
    The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male 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.
    Other Name: Device: AdVance Male Sling

Primary Outcome Measures :
  1. To obtain procedural technique data for use in physician education and training [ Time Frame: 24 months ]
  2. To collect clinical outcomes data for future publication [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To record adverse events at implant and follow-up time-points [ Time Frame: 24 months ]
  2. To characterize incontinence severity at specified time-points [ Time Frame: 24 months ]
  3. To evaluate patient quality of life [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The subject has agreed to be implanted with the AMS AdVance Male 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 and has less than 250 grams on the 24-hour pad weight test.
  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, or radical 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 a post-void residual ≥ 100 cc.
  3. The subject has detrusor-external sphincter dyssynergia.
  4. The subject has a urinary tract infection (UTI).
  5. The subject was treated with pelvic radiation within the last 6 months.
  6. The subject currently has an inflatable penile prosthesis.
  7. The subject self-catheterizes.
  8. The subject has symptomatic or unstable bladder neck structure disease.
  9. The subject has a history of urethral strictures that may require repetitive instrumentation.
  10. 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).
  11. The subject has a history of connective tissue or autoimmune conditions.
  12. The subject has a compromised immune system.
  13. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
  14. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00998790

Universitaire Ziekenhuisen Leuven
Leuven, Belgium
Clinique Jules Verne
Nantes, Cedex 3, France, 44314
Hopital Edouard Herriot
Lyon Cedex 03, France, 69435
Sponsors and Collaborators
American Medical Systems
Principal Investigator: Armin Becker, MD Oberarzt der Urologischen Klinik Grosshadern
Principal Investigator: Dirk de Ridder, Professor UZ Gasthuisberg
Principal Investigator: Pedro Arano, MD Fundacion Puigvert
Principal Investigator: Francois Haab, Professor Institution Tenon Hospital
Principal Investigator: Olivier Haillot, Professor Hopital Bretonneau
Principal Investigator: Philippe Chauveau, MD Clinique Jules Verne
Principal Investigator: Hakim Fassi-Fehri, MD Hopital Edouard Herriot

Responsible Party: Tim De Groot, Sr. Clinical Program Manager, American Medical Systems Identifier: NCT00998790     History of Changes
Other Study ID Numbers: MC0602
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011

Keywords provided by American Medical Systems:
Urinary Incontinence, Stress
Intrinsic sphincter deficiency
Radical prostatectomy
Open prostatectomy
Post-suprapubic prostatectomy

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders