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Completed

NCT Number: NCT01725984

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ludwig-Maximilians Universität (LMU)

Munich, Bavaria, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use

    Time frame: 3 Months Post Procedure

    Evaluate the proportion of subjects with a ≥50% reduction in pads per day use

  2. Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use

    Time frame: 3 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

  3. Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use

    Time frame: Baseline

    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);

  4. Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit

    Time frame: 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.

  5. 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.

    Time frame: 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.

  6. Number of Adverse Events Reported Between Arms

    Time frame: 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

  7. Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use

    Time frame: Prospective follow-up to 36 Months Post Procedure

    Evaluate the proportion of subjects with a ≥50% reduction in pads per day use

  8. Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use

    Time frame: 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

  9. Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use

    Time frame: 3 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);

  10. Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use

    Time frame: 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);

Sponsors and collaborators

Lead sponsor

American Medical Systems

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 14, 2012
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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