Clinical trial NCT00998790: A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
Official title: A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence, Stress
Intrinsic sphincter deficiency
Secondary
TUR
TURP
Radical prostatectomy
Open prostatectomy
Post-suprapubic prostatectomy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 114
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up
timeFrame: 24 months
measure: Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
timeFrame: 24 months
measure: Percentage of Subjects in Each Range of Pads Per Day Use
timeFrame: Baseline
measure: Percentage of Subjects in Each Range of Pads Per Day Use
timeFrame: 24 months
Secondary outcomes:
measure: To Evaluate Patient Quality of Life
timeFrame: 24 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuisen Leuven
city: Nantes
country: France
facility: Clinique Jules Verne
state: Cedex 3
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
Study officials:
affiliation: Oberarzt der Urologischen Klinik Grosshadern
name: Armin Becker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gasthuisberg
name: Dirk de Ridder, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Puigvert
name: Pedro Arano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institution Tenon Hospital
name: Francois Haab, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Bretonneau
name: Olivier Haillot, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Jules Verne
name: Philippe Chauveau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Edouard Herriot
name: Hakim Fassi-Fehri, MD
role: PRINCIPAL_INVESTIGATOR
References: