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

NCT01725984 | Completed Results

• 1 other identifier: MC1201
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Stress; Intrinsic Sphincter Deficiency

Keywords

Male Incontinence; AdVance Male Sling; AdVance XP Male Sling; Male Sling

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

AdVance

Subjects previously implanted with the AdVance Male Sling

AdVance XP

Subjects previously implanted with the AdVance XP male sling

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Medical Systems: lead

Study Sites (1)

Ludwig-Maximilians Universität (LMU)

Munich, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ricarda Bauer
• Organization: Ludwig Maximilian Universität

Ricarda.Bauer@med.uni-muenchen.de

+49 89 7095

Study Officials

• Ricarda Bauer, MD

  Ludwig-Maximilians Universität (LMU)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: November 14, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: June 30, 2015
• Results First Posted: June 30, 2015

Record last verified: 2015-06

Locations

DE (1)