Pelvic Floor Repair Systems for Prolapse Repair (PROPEL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by American Medical Systems.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00638235
First received: February 28, 2008
Last updated: January 27, 2011
Last verified: January 2011
  Purpose
  1. This is a prospective, single arm, multi-center, post market study, which will be conducted under a common protocol.
  2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
  3. The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
  4. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control.The follow-up is for two years after the procedure.
  5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.

Condition Intervention
Pelvic Organ Prolapse
Device: AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic)
Device: AMS Perigee™ with IntePro
Device: AMS Apogee™ with IntePro Lite and/or AMS Perigee™ with IntePro Lite
Device: AMS Elevate™ Apical & Posterior
Device: AMS Elevate™ Apical & Anterior (original design)
Device: AMS Elevate™ Apical & Anterior

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • Percent of subjects with an ICS POP-Q Stage of </= Stage I [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life as measure by Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [ Time Frame: 6, 12, & 24 months ] [ Designated as safety issue: No ]
  • Procedural time [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Estimated blood loss [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]
  • Percent of subjects experiencing major device related complications [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
  • Rate of graft extrusions [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
  • Rates of de novo or worsening urinary and/or anal incontinence [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
  • Percent of subjects with an ICS POP-Q Stage of </= Stage I [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
  • Wong-Baker Faces Pain Scale [ Time Frame: 6 weeks and 3 months ] [ Designated as safety issue: Yes ]
  • Patient Satisfaction Questionnaire [ Time Frame: 6, 12, & 24 months ] [ Designated as safety issue: No ]
  • Surgical revision rate [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: May 2006
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phase I (US only)
AMS Apogee™ with IntePro or InteXen (Began May 2006 - Closed)
Device: AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic)
Mesh implant for posterior wall pelvic organ prolapse
Phase II (France only)
Perigee™ with IntePro (Began February 2007 - Closed)
Device: AMS Perigee™ with IntePro
Mesh implant for anterior wall pelvic organ prolapse
Phase III/IV (US only)
AMS Apogee™ with IntePro Lite and/or AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)
Device: AMS Apogee™ with IntePro Lite and/or AMS Perigee™ with IntePro Lite
Mesh implant for the treatment of anterior and/or posterior wall pelvic organ prolapse.
Phase V (US & Europe)
AMS Elevate™ Apical & Posterior (Began April 2008 - Closed to enrollment)
Device: AMS Elevate™ Apical & Posterior
Mesh implant for the treatment of apical and posterior wall pelvic organ prolapse
Phase VI (Europe only)
AMS Elevate™ Apical & Anterior (Original design - began October 2008 - Closed)
Device: AMS Elevate™ Apical & Anterior (original design)
Mesh implant for treatment of apical and anterior wall pelvic organ prolapse.
Phase VII (US & Europe)
AMS Elevate™ Apical & Anterior (Current design - began April 2009 - Closed to enrollment)
Device: AMS Elevate™ Apical & Anterior
Mesh implant for the treatment of apical and anterior wall pelvic organ prolapse.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair

Exclusion Criteria:

  • The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse.
  • Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
  • Subject has active or latent systemic infection or signs of tissue necrosis.
  • Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis.
  • Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered.
  • Subject has had radiation therapy to the pelvic area.
  • Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
  • Subject has a known hypersensitivity to the graft material(s).
  • Subject has uncontrolled diabetes.
  • Subject is on any medication which could result in compromised immune response, such as immune modulators.
  • Subject was involved in any other research trial < 30 days of enrollment into this study.
  • Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
  • Subject is unwilling or unable to give valid informed consent.
  • Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits.
  • Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
  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: NCT00638235

  Show 28 Study Locations
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: James C. Lukban, DO Eastern Virginia Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Madej/Clinical Project Leader, AMS
ClinicalTrials.gov Identifier: NCT00638235     History of Changes
Obsolete Identifiers: NCT00793039
Other Study ID Numbers: 1004
Study First Received: February 28, 2008
Last Updated: January 27, 2011
Health Authority: United States: Institutional Review Board
Europe: Ethics Committees

Keywords provided by American Medical Systems:
Pelvic floor repair
prolapse
mesh

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014