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AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up

NCT ID: NCT01725984

Last Updated: 2015-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-01-31

Brief Summary

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A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling.

Detailed Description

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A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling.

Conditions

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Urinary Incontinence, Stress Intrinsic Sphincter Deficiency

Keywords

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Male Incontinence AdVance Male Sling AdVance XP Male Sling Male Sling

Study Design

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Observational Model Type

COHORT

Study Groups

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AdVance

Subjects previously implanted with the AdVance Male Sling

No interventions assigned to this group

AdVance XP

Subjects previously implanted with the AdVance XP male sling

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Valid, written informed consent has been obtained
2. Male subject ≥40 years of age who received the AdVance male sling after January 1, 2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI
3. Pad use of 1 to 8 pads per day prior to sling placement (subjects who used only a dry prophylactic pad or safety liner at baseline will not be included)
4. External (distal) sphincter contractility and a coaptive zone of ≥ 1cm confirmed by endoscopic view prior to sling placement
5. Primary etiology of SUI resulting from radical prostatectomy including, simple open prostatectomy, robotic or laparoscopic prostatectomy

Exclusion Criteria

1. Pad use of more than 8 pads per day prior to sling placement for incontinence management
2. Urine loss while lying in bed prior to sling placement
3. Treatment with a urethral sling system, an AMS Sphincter 800®, or any implanted device for the treatment of urinary incontinence (not including bulking agents) prior to sling placement
4. TURP procedure prior to sling placement
5. Urge predominant incontinence prior to sling placement
6. Past or current neurological disorder (e.g. neurogenic bladder, multiple sclerosis, Parkinson's disease)
7. History of connective tissue or autoimmune conditions
8. Past or current condition of compromised immune system
9. Placement of an inflatable penile prosthesis (IPP) after sling placement
10. Post void residual of \>50 ml prior to sling placement
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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American Medical Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricarda Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians Universität (LMU)

Locations

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Ludwig-Maximilians Universität (LMU)

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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MC1201

Identifier Type: -

Identifier Source: org_study_id