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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by American Medical Systems.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00998790
First received: October 8, 2009
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • To obtain procedural technique data for use in physician education and training [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To collect clinical outcomes data for future publication [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To record adverse events at implant and follow-up time-points [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To characterize incontinence severity at specified time-points [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To evaluate patient quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: January 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998790

Locations
Belgium
Universitaire Ziekenhuisen Leuven
Leuven, Belgium
France
Clinique Jules Verne
Nantes, Cedex 3, France, 44314
Hopital Edouard Herriot
Lyon Cedex 03, France, 69435
Sponsors and Collaborators
American Medical Systems
Investigators
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
  More Information

No publications provided

Responsible Party: Tim De Groot, Sr. Clinical Program Manager, American Medical Systems
ClinicalTrials.gov Identifier: NCT00998790     History of Changes
Other Study ID Numbers: MC0602
Study First Received: October 8, 2009
Last Updated: March 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014