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Pelvic Floor Repair Systems for Prolapse Repair (PROPEL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ASTORA Women's Health
ClinicalTrials.gov Identifier:
NCT00638235
First received: February 28, 2008
Last updated: September 6, 2016
Last verified: September 2016
  Purpose
  1. This is a prospective, 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
Device: AMS Apogee™ with Intexen LP
Device: AMS Perigee™ with IntePro
Device: AMS Perigee™ with IntePro Lite
Device: AMS Apogee™ with IntePro Lite
Device: AMS Elevate™ Apical & Posteiror with IntePro Lite
Device: AMS Elevate™ Apical & Posteiror with IntXen LP
Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)
Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 ASTORA Women's Health:

Primary Outcome Measures:
  • Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.


Secondary Outcome Measures:
  • QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

    Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline.

    Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.


  • Procedural Time [ Time Frame: Approximately 30 minutes ] [ Designated as safety issue: No ]
    Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes

  • Estimated Blood Loss [ Time Frame: Approximately 30 minutes ] [ Designated as safety issue: Yes ]
    Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml

  • Percent of Subjects Experiencing Major Device Related Complications [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
    This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure

  • Rate of Graft Extrusions [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
    Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall

  • Rates of de Novo or Worsening Urinary and/or Anal Incontinence [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
    Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence

  • Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: Yes ]
    Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating "hurts worst") at baseline, and 6 weeks post procedure

  • Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.

  • Surgical Revision Rate [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
    The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.

    Note:

    1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
    2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design

  • Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.

  • Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.

    Note:

    1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
    2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design

  • Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.

  • Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.

  • Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.

    Note:

    1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
    2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design

  • Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.

  • Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.

  • Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.

    Note:

    1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
    2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design

  • Wong-Baker Faces Pain Scale at 3 Months Post Procedure [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure

  • QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 [ Time Frame: baseline and 24 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. .

  • QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M [ Time Frame: baseline and 24 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M [ Time Frame: baseline and 24 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M [ Time Frame: baseline and 24 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M [ Time Frame: baseline and 24 months ] [ Designated as safety issue: No ]
    Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.


Other Outcome Measures:
  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.

  • Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.


Enrollment: 725
Study Start Date: May 2006
Study Completion Date: September 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phase I (IntePro, US only)
AMS Apogee™ with IntePro(Began May 2006 - Closed)
Device: AMS Apogee™ with IntePro
Mesh implant for posterior wall pelvic organ prolapse
Phase I (InteXen LP, US only)
AMS Apogee™ with InteXen LP (Began May 2006 - Closed)
Device: AMS Apogee™ with Intexen LP
Graft implant for posterior wall pelvic organ prolapse
Phase II (France only)
AMS Perigee™ with IntePro (Began February 2007 - Closed)
Device: AMS Perigee™ with IntePro
Mesh implant for anterior wall pelvic organ prolapse
Phase III/IV (Perigee IntePro Lite, US only)
AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)
Device: AMS Perigee™ with IntePro Lite
Mesh implant for anterior wall pelvic organ prolapse
Phase III/IV (Apogee IntePro Lite, US only)
AMS Apogee™ with IntePro Lite (Began April 2007 - Closed)
Device: AMS Apogee™ with IntePro Lite
Mesh implant for posterior wall pelvic organ prolapse
Phase V (Elevate Posterior IntePro Lite, US & EU)
AMS Elevate™ Apical & Posteiror with IntePro Lite (Began April 2008 - Closed)
Device: AMS Elevate™ Apical & Posteiror with IntePro Lite
Mesh implant for apical and posterior wall pelvic organ prolapse
Phase V (Elevate Posterior InteXen, US only)
AMS Elevate™ Apical & Posteiror with IntXen LP (Began April 2008 - Closed)
Device: AMS Elevate™ Apical & Posteiror with IntXen LP
Graft implant for apical and posterior wall pelvic organ prolapse
Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only)
AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed)
Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)
Mesh implant for anteiror and apical wall pelvic organ prolapse
Phase VII (Elevate Anterior Gen 2, US & EU)
AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 2, Began April 2009 - Closed)
Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)
Mesh implant for anteiror and apical wall pelvic organ prolapse

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult females ages > 21 years old requiring surgical repair of their genital prolapse
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
ASTORA Women's Health
Investigators
Principal Investigator: James C. Lukban, DO Eastern Virginia Medical School
  More Information

Additional Information:
Publications:
Responsible Party: ASTORA Women's Health
ClinicalTrials.gov Identifier: NCT00638235     History of Changes
Obsolete Identifiers: NCT00793039
Other Study ID Numbers: 1004 
Study First Received: February 28, 2008
Results First Received: September 6, 2016
Last Updated: September 6, 2016
Health Authority: United States: Institutional Review Board
Europe: Ethics Committees
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by ASTORA Women's Health:
Pelvic floor repair
prolapse
mesh

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

ClinicalTrials.gov processed this record on December 08, 2016