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Completed

NCT Number: NCT00638235

Pelvic Floor Repair Systems for Prolapse Repair

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UZ Leuven Dept of Urology, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

AMS Apogee™ with IntePro

Device

Mesh implant for posterior wall pelvic organ prolapse

AMS Apogee™ with Intexen LP

Device

Graft implant for posterior wall pelvic organ prolapse

AMS Perigee™ with IntePro

Device

Mesh implant for anterior wall pelvic organ prolapse

AMS Perigee™ with IntePro Lite

Device

Mesh implant for anterior wall pelvic organ prolapse

AMS Apogee™ with IntePro Lite

Device

Mesh implant for posterior wall pelvic organ prolapse

AMS Elevate™ Apical & Posteiror with IntePro Lite

Device

Mesh implant for apical and posterior wall pelvic organ prolapse

AMS Elevate™ Apical & Posteiror with IntXen LP

Device

Graft implant for apical and posterior wall pelvic organ prolapse

AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)

Device

Mesh implant for anteiror and apical wall pelvic organ prolapse

AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)

Device

Mesh implant for anteiror and apical wall pelvic organ prolapse

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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 outcomes

  1. 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

    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.

  2. Procedural Time

    Time frame: Approximately 30 minutes

    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

  3. Estimated Blood Loss

    Time frame: Approximately 30 minutes

    Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml

  4. Percent of Subjects Experiencing Major Device Related Complications

    Time frame: Through 24 months

    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

  5. Rate of Graft Extrusions

    Time frame: Through 24 months

    Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall

  6. Rates of de Novo or Worsening Urinary and/or Anal Incontinence

    Time frame: Through 24 months

    Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence

  7. Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure

    Time frame: baseline and 6 weeks

    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

  8. Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)

    Time frame: 6 Months

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

  9. Surgical Revision Rate

    Time frame: Through 24 months

    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.

  10. Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months

    Time frame: 6 months

    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.

  11. Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months

    Time frame: 24 months

    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:

    • Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
    • 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

  12. Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)

    Time frame: 12 months

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

  13. Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)

    Time frame: 24 months

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

    Note:

    • Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
    • 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

  14. Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)

    Time frame: 6 months

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

  15. Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)

    Time frame: 12 months

    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.

  16. Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)

    Time frame: 24 months

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

    Note:

    • Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
    • 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

  17. Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)

    Time frame: 6 months

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

  18. Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)

    Time frame: 12 months

    Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.

  19. Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)

    Time frame: 24 months

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

    Note:

    • Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
    • 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

  20. Wong-Baker Faces Pain Scale at 3 Months Post Procedure

    Time frame: baseline and 3 months

    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

  21. 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

    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.

  22. 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

    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.

  23. 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

    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. .

  24. 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

    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.

  25. 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

    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.

  26. 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

    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.

  27. 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

    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.

  28. 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

    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.

  29. 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

    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.

  30. 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

    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.

  31. 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

    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.

  32. 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

    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.

  33. 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

    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.

  34. 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

    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.

  35. Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure

    Time frame: 6 months

    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.

  36. Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure

    Time frame: 24 months

    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.

  37. Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure

    Time frame: 6 months

    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.

  38. Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure

    Time frame: 24 months

    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 outcomes

  1. Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure

    Time frame: 6 months

    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.

  2. Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

ASTORA Women's Health

Industry

Registry information

Official study title

A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair

Acronym: PROPEL

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Mar 19, 2008
Registry last updated
Oct 28, 2016

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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