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

Primary Purpose

Stress Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

American Medical Systems (AMS) AdVance™ Male Sling System

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, TUR, TURP, Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

The subject has agreed to be implanted with the AMS AdVance Male Sling System.
The subject is willing and able to give valid informed consent.
The subject is ≥40 years of age.
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.
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.
Internal sphincter contractility confirmed by endoscopic view.
The subject's primary etiology is TUR, TURP, or radical prostatectomy.
Pre-existing urological conditions, other than incontinence have been treated and are under control.
The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
The subject is a good surgical candidate.

Exclusion Criteria:

The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
The subject has a post-void residual ≥ 100 cc.
The subject has detrusor-external sphincter dyssynergia.
The subject has a urinary tract infection (UTI).
The subject was treated with pelvic radiation within the last 6 months.
The subject currently has an inflatable penile prosthesis.
The subject self-catheterizes.
The subject has symptomatic or unstable bladder neck structure disease.
The subject has a history of urethral strictures that may require repetitive instrumentation.
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).
The subject has a history of connective tissue or autoimmune conditions.
The subject has a compromised immune system.
The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Sites / Locations

Universitaire Ziekenhuisen Leuven
Clinique Jules Verne
Hopital Edouard Herriot

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMS AdVance Sling Group

Arm Description

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

Outcomes

Primary Outcome Measures

Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up

1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.

Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up

24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.

Percentage of Subjects in Each Range of Pads Per Day Use

Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day

Percentage of Subjects in Each Range of Pads Per Day Use

Secondary Outcome Measures

To Evaluate Patient Quality of Life

The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100. The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 0-21.

Full Information

NCT ID

NCT00998790

First Posted

October 8, 2009

Last Updated

January 4, 2018

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00998790

Brief Title

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

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

Keywords

Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, TUR, TURP, Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMS AdVance Sling Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

American Medical Systems (AMS) AdVance™ Male Sling System

Other Intervention Name(s)

Device: AdVance Male Sling

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up

Description

1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.

Time Frame

24 months

Title

Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up

Description

24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.

Time Frame

24 months

Title

Percentage of Subjects in Each Range of Pads Per Day Use

Description

Time Frame

Baseline

Title

Percentage of Subjects in Each Range of Pads Per Day Use

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

To Evaluate Patient Quality of Life

Description

Time Frame

24 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject has agreed to be implanted with the AMS AdVance Male Sling System. The subject is willing and able to give valid informed consent. The subject is ≥40 years of age. 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. 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. Internal sphincter contractility confirmed by endoscopic view. The subject's primary etiology is TUR, TURP, or radical prostatectomy. Pre-existing urological conditions, other than incontinence have been treated and are under control. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol. The subject is a good surgical candidate. Exclusion Criteria: The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods. The subject has a post-void residual ≥ 100 cc. The subject has detrusor-external sphincter dyssynergia. The subject has a urinary tract infection (UTI). The subject was treated with pelvic radiation within the last 6 months. The subject currently has an inflatable penile prosthesis. The subject self-catheterizes. The subject has symptomatic or unstable bladder neck structure disease. The subject has a history of urethral strictures that may require repetitive instrumentation. 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). The subject has a history of connective tissue or autoimmune conditions. The subject has a compromised immune system. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Overall Study Officials: