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

Completed

Conditions: Intrinsic Sphincter Deficiency
Urinary Incontinence, Stress

Registration Number: NCT01725984

Lead Sponsor: American Medical Systems

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 80

Inclusion Criteria

Valid, written informed consent has been obtained
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
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)
External (distal) sphincter contractility and a coaptive zone of ≥ 1cm confirmed by endoscopic view prior to sling placement
Primary etiology of SUI resulting from radical prostatectomy including, simple open prostatectomy, robotic or laparoscopic prostatectomy

Exclusion Criteria

Pad use of more than 8 pads per day prior to sling placement for incontinence management
Urine loss while lying in bed prior to sling placement
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
TURP procedure prior to sling placement
Urge predominant incontinence prior to sling placement
Past or current neurological disorder (e.g. neurogenic bladder, multiple sclerosis, Parkinson's disease)
History of connective tissue or autoimmune conditions
Past or current condition of compromised immune system
Placement of an inflatable penile prosthesis (IPP) after sling placement
Post void residual of >50 ml prior to sling placement

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	Prospective follow-up to 36 Months Post Procedure	Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use	Prospective follow-up to 36 Months Post Procedure	Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use	Prospective follow-up to 36 Months Post Procedure	Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.	Baseline to Prospective Follow Up (up to 36 months)	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 1-21. The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.
Number of Adverse Events Reported Between Arms	Prospective follow-up to 36 Months Post Procedure	Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit	Prospective follow-up to 36 Months Post Procedure	Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.