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

American Medical Systems

Status: Completed

Conditions: Urinary Incontinence, Stress; Intrinsic Sphincter Deficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT01725984

MC1201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

AdVance

Description:

Subjects previously implanted with the AdVance Male Sling

AdVance XP

Description:

Subjects previously implanted with the AdVance XP male sling