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

NCT ID: NCT00998790

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMS AdVance Sling Group

European Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.

Group Type: EXPERIMENTAL

American Medical Systems (AMS) AdVance™ Male Sling System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Device: AdVance Male Sling

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armin Becker, MD

Role: PRINCIPAL_INVESTIGATOR

Oberarzt der Urologischen Klinik Grosshadern

Dirk de Ridder, Professor

Role: PRINCIPAL_INVESTIGATOR

UZ Gasthuisberg

Pedro Arano, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Puigvert

Francois Haab, Professor

Role: PRINCIPAL_INVESTIGATOR

Institution Tenon Hospital

Olivier Haillot, Professor

Role: PRINCIPAL_INVESTIGATOR

Hopital Bretonneau

Philippe Chauveau, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Jules Verne

Hakim Fassi-Fehri, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Edouard Herriot

Locations

Universitaire Ziekenhuisen Leuven

Leuven, , Belgium

Clinique Jules Verne

Nantes, Cedex 3, France

Hopital Edouard Herriot

Lyon, , France

Countries

Belgium; France

Other Identifiers

MC0602

Identifier Type: -

Identifier Source: org_study_id