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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress; Intrinsic Sphincter Deficiency

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Ludwig-Maximilians Universität (LMU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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 at one institution in Munich, Germany.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AdVance; Subjects previously implanted with the AdVance Male Sling
AdVance XP; Subjects previously implanted with the AdVance XP male sling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use	Evaluate the proportion of subjects with a ≥50% reduction in pads per day use	3 Months Post Procedure
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use	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	3 months Post Procedure
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	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);	Baseline
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit	Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.	Prospective follow-up to 36 Months Post Procedure
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.	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.	Baseline to Prospective Follow Up (up to 36 months)
Number of Adverse Events Reported Between Arms	Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events	Prospective follow-up to 36 Months Post Procedure
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use	Evaluate the proportion of subjects with a ≥50% reduction in pads per day use	Prospective follow-up to 36 Months Post Procedure
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use	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	Prospective follow-up to 36 Months Post Procedure
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	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);	3 Months Post Procedure
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	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);	Prospective follow-up to 36 Months Post Procedure

Collaborators and Investigators

• Sponsor: American Medical Systems
• Investigators: Principal Investigator: Ricarda Bauer, MD, Ludwig-Maximilians Universität (LMU)

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: July 13, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (ESTIMATE): November 14, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Male Sling; Male Incontinence; AdVance Male Sling; AdVance XP Male Sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: MC1201