N/A N=80

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

Urinary Incontinence, Stress · Intrinsic Sphincter Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT01725984 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Jun 2015

Primary outcome: Primary: Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use — 87.2; 97.6 percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: American Medical Systems
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use	69.2; 90.2	—
PRIMARY Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use	46.2; 65.9; 23.1; 24.4; 30.8; 9.8	—
PRIMARY Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	46.2; 65.9; 23.1; 12.2; 10.3; 17.1	—
PRIMARY Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit	59.0; 68.3; 30.8; 22.0; 10.3; 9.8	—
PRIMARY 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.	46.5; 45.6; 81.4; 85.4; 79.9; 86.8	—
PRIMARY Number of Adverse Events Reported Between Arms	9; 12; 8; 8; 5; 8	—
PRIMARY Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use	69.2; 90.2	—
PRIMARY Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use	46.2; 65.9; 23.1; 24.4; 30.8; 9.8	—
PRIMARY Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	46.2; 65.9; 23.1; 12.2; 10.3; 17.1	—
PRIMARY Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	46.2; 65.9; 23.1; 12.2; 10.3; 17.1	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01725984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.