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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT01725984
First received: July 13, 2012
Last updated: June 25, 2015
Last verified: June 2015
  Purpose

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.


Condition Phase
Urinary Incontinence, Stress
Intrinsic Sphincter Deficiency
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: 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

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use [ Time Frame: 3 Months Post Procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months Post Procedure ] [ Designated as safety issue: No ]
    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

  • Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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);


  • Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit [ Time Frame: Prospective follow-up to 36 Months Post Procedure ] [ Designated as safety issue: No ]
    Percentage of subjects at a given weight for their 24-hour pad weight test at the 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. [ Time Frame: Baseline to Prospective Follow Up (up to 36 months) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Prospective follow-up to 36 Months Post Procedure ] [ Designated as safety issue: Yes ]
    Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events

  • Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use [ Time Frame: Prospective follow-up to 36 Months Post Procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Prospective follow-up to 36 Months Post Procedure ] [ Designated as safety issue: No ]
    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

  • Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use [ Time Frame: 3 Months Post Procedure ] [ Designated as safety issue: No ]

    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 in Each Pre-defined Range of Pads Per Day Use [ Time Frame: Prospective follow-up to 36 Months Post Procedure ] [ Designated as safety issue: No ]

    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);



Enrollment: 80
Study Start Date: August 2012
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
AdVance
Subjects previously implanted with the AdVance Male Sling
AdVance XP
Subjects previously implanted with the 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725984

Locations
Germany
Ludwig‐Maximilians Universität (LMU)
Munich, Bavaria, Germany, 81377
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: Ricarda Bauer, MD Ludwig‐Maximilians Universität (LMU)
  More Information

No publications provided

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT01725984     History of Changes
Other Study ID Numbers: MC1201
Study First Received: July 13, 2012
Results First Received: March 17, 2015
Last Updated: June 25, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by American Medical Systems:
Male Incontinence
AdVance Male Sling
AdVance XP Male Sling
Male Sling

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on September 03, 2015