Pelvic Organ ProlapsePROPELNCT00638235
Pelvic Floor Repair Systems for Prolapse Repair
An observational study of Pelvic Organ Prolapse, run by ASTORA Women's Health at 28 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP and AMS Perigee™ with IntePro
- Type of treatment
- Medical device
- How many people
- 725 participants
- Where
- 28 sitesin 7 countries
- Study dates
- May 2006to Sep 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult females ages > 21 years old requiring surgical repair of their genital prolapse
Who may be able to join
- -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
Who cannot join
- 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.
Show all 15Show fewer
- 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).
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
United States17 sites
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005
South Carolina OB/GYN
Columbia, South Carolina, 29201
Kaiser Permanente - Dept. of Obstetrics & Gynecology
Downey, California, 90242
Texas Tech University Health Science Center - OB/GYN Department
El Paso, Texas, 79905
Huey & Weprin Obstetrics & Gynecology
Englewood, Ohio, 45322
Piedmont Urology Associates
Gastonia, North Carolina, 28054
Female Pelvic Medicine and Urogynecology Inst. of Michigan
Grand Rapids, Michigan, 49503
Michigan Medical P.C.
Grand Rapids, Michigan, 49546
Rosemark Womencare Specialists
Idaho Falls, Idaho, 83404
University of Tennessee - Dept of Obstetrics & Gynecology
Memphis, Tennessee, 38103
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Women's Health Care Specialists, PC
Paw Paw, Michigan, 49079
Metro Urology
Plymouth, Minnesota, 55441
Fore River Urology
Portland, Maine, 04102
Maine Medical Partners
Portland, Maine, 04102
Institute for Women's Health & Body
Wellington, Florida, 33414
Female Pelvic Health
Whitinsville, Massachusetts, 01588
France5 sites
CMC Beau Soleil
Montpellier, 34070
Service urologie de Paris l'Hôpital Tenon
Paris, 75020
Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest
Paris
CHU de Rouen - Pavillon Derocque - Rez de Chaussée
Rouen, 76031
Clinique Adassa
Strasbourg, 67082
Germany2 sites
Dr. Rainer Lange
Alzey, 55232
Beckenbodenzentrum Munich
Munich, 81679
Netherlands1 site
University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics
Amsterdam, 1105AZ
United Kingdom1 site
University Hospital of Leicester NHS Trust
Leicester, LE5 4PW
About this study
Official title: A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair
- This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
- The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
- The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
- 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.
- 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP, AMS Perigee™ with IntePro, AMS Perigee™ with IntePro Lite, AMS Apogee™ with IntePro Lite
- Keywords
- Pelvic floor repair, prolapse, mesh
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMS Apogee™ with InteProDevice
Mesh implant for posterior wall pelvic organ prolapse
AMS Apogee™ with Intexen LPDevice
Graft implant for posterior wall pelvic organ prolapse
AMS Perigee™ with InteProDevice
Mesh implant for anterior wall pelvic organ prolapse
AMS Perigee™ with IntePro LiteDevice
Mesh implant for anterior wall pelvic organ prolapse
AMS Apogee™ with IntePro LiteDevice
Mesh implant for posterior wall pelvic organ prolapse
AMS Elevate™ Apical & Posteiror with IntePro LiteDevice
Mesh implant for apical and posterior wall pelvic organ prolapse
AMS Elevate™ Apical & Posteiror with IntXen LPDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Phase I (IntePro, US only) | AMS Apogee™ with IntePro(Began May 2006 - Closed) Receives: Device: AMS Apogee™ with IntePro | |
| Phase I (InteXen LP, US only) | AMS Apogee™ with InteXen LP (Began May 2006 - Closed) Receives: Device: AMS Apogee™ with Intexen LP | |
| Phase II (France only) | AMS Perigee™ with IntePro (Began February 2007 - Closed) Receives: Device: AMS Perigee™ with IntePro | |
| Phase III/IV (Perigee IntePro Lite, US only) | AMS Perigee™ with IntePro Lite (Began April 2007 - Closed) Receives: Device: AMS Perigee™ with IntePro Lite | |
| Phase III/IV (Apogee IntePro Lite, US only) | AMS Apogee™ with IntePro Lite (Began April 2007 - Closed) Receives: Device: AMS Apogee™ with IntePro Lite | |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical \& Posteiror with IntePro Lite (Began April 2008 - Closed) Receives: Device: AMS Elevate™ Apical & Posteiror with IntePro Lite | |
| Phase V (Elevate Posterior InteXen, US only) | AMS Elevate™ Apical \& Posteiror with IntXen LP (Began April 2008 - Closed) Receives: Device: AMS Elevate™ Apical & Posteiror with IntXen LP | |
| 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) Receives: Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only) | |
| Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 2, Began April 2009 - Closed) Receives: Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 12-months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure
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.
Measured: 12-months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure
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.
Measured: 12-months
Secondary outcomes (38)
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
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.
Measured: 6 Months
Procedural Time
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
Measured: Approximately 30 minutes
Estimated Blood Loss
Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml
Measured: Approximately 30 minutes
Percent of Subjects Experiencing Major Device Related Complications
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
Measured: Through 24 months
Rate of Graft Extrusions
Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall
Measured: Through 24 months
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence
Measured: Through 24 months
Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure
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
Measured: baseline and 6 weeks
Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Measured: 6 Months
Surgical Revision Rate
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.
Measured: Through 24 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 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.
Measured: 6 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 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
Measured: 24 months
Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Measured: 12 months
Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
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
Measured: 24 months
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Measured: 6 months
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
Measured: 12 months
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
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
Measured: 24 months
Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Measured: 6 months
Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
Measured: 12 months
Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)
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
Measured: 24 months
Wong-Baker Faces Pain Scale at 3 Months Post Procedure
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
Measured: baseline and 3 months
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
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.
Measured: 12 months
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
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.
Measured: baseline and 24 months
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M
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. .
Measured: baseline and 6 months
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M
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.
Measured: baseline and 12 months
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M
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.
Measured: baseline and 24 months
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
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.
Measured: baseline and 6 months
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M
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.
Measured: baseline and 12 months
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M
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.
Measured: baseline and 24 months
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M
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.
Measured: baseline and 6 months
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M
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.
Measured: baseline and 6 months
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M
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.
Measured: baseline and 12 months
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M
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.
Measured: baseline and 24 months
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M
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.
Measured: baseline and 12 months
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M
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.
Measured: baseline and 24 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure
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.
Measured: 6 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure
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.
Measured: 24 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure
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.
Measured: 6 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMay 2006
- Primary completionFeb 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASTORA Women's Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James C. Lukban, DO, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638235
- Sponsor's protocol ID
- 1004
- Acronym
- PROPEL
- Status last verified
- Sep 2016
- First submitted
- 28 Feb 2008
- Last updated
- 28 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lukban JC, Roovers JP, Vandrie DM, Erickson T, Zylstra S, Patel MP, Moore RD. Single-incision apical and posterior mesh repair: 1-year prospective outcomes. Int Urogynecol J. 2012 Oct;23(10):1413-9. doi: 10.1007/s00192-012-1692-4. Epub 2012 Mar 15.
PubMed 22419354Lukban JC, Beyer RD, Moore RD. Incidence of extrusion following type I polypropylene mesh "kit" repairs in the correction of pelvic organ prolapse. Obstet Gynecol Int. 2012;2012:354897. doi: 10.1155/2012/354897. Epub 2011 Dec 10.
PubMed 22190952Moore RD, Lukban JC. Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse. Int Urogynecol J. 2012 Oct;23(10):1379-86. doi: 10.1007/s00192-012-1744-9. Epub 2012 May 10.
PubMed 22572917Schmidbauer L, Liedl B, Goeschen K, Antoniewicz A, Kurtzman J, Wenk MJ. Coexistence of Pelvic Pain, Bladder, and Bowel Symptoms in Women with Pelvic Organ Prolapse: The Effect of Transvaginal Surgery. Int Urogynecol J. 2026 Mar;37(3):691-698. doi: 10.1007/s00192-025-06348-y. Epub 2025 Nov 8.
PubMed 41204973Liedl B, Barba M, Wenk M. [Pelvic floor reconstruction-update 2024: prolapse-associated symptoms and their treatment]. Urologie. 2024 Jan;63(1):43-50. doi: 10.1007/s00120-023-02247-6. Epub 2023 Dec 28. German.
PubMed 38153429Himmler M, Gottl K, Witczak M, Yassouridis A, Gold DM, Liedl B. The impact of transvaginal, mesh-augmented level one apical repair on anorectal dysfunction due to pelvic organ prolapse. Int Urogynecol J. 2022 Nov;33(11):3261-3273. doi: 10.1007/s00192-022-05151-3. Epub 2022 Mar 28.
PubMed 35347368
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair
- ClinicalTrials.gov ID
- NCT00638235
- Acronym / sponsor ID
- PROPEL / 1004
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic floor repair, prolapse, mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 725 participants (actual)
- Lead sponsor
- ASTORA Women's HealthIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Posted 28 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
- The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
- The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Phase I (IntePro, US only) | – | Device: AMS Apogee™ with InteProAMS Apogee™ with IntePro(Began May 2006 - Closed) |
| Phase I (InteXen LP, US only) | – | Device: AMS Apogee™ with Intexen LPAMS Apogee™ with InteXen LP (Began May 2006 - Closed) |
| Phase II (France only) | – | Device: AMS Perigee™ with InteProAMS Perigee™ with IntePro (Began February 2007 - Closed) |
| Phase III/IV (Perigee IntePro Lite, US only) | – | Device: AMS Perigee™ with IntePro LiteAMS Perigee™ with IntePro Lite (Began April 2007 - Closed) |
| Phase III/IV (Apogee IntePro Lite, US only) | – | Device: AMS Apogee™ with IntePro LiteAMS Apogee™ with IntePro Lite (Began April 2007 - Closed) |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | – | Device: AMS Elevate™ Apical & Posteiror with IntePro LiteAMS Elevate™ Apical \& Posteiror with IntePro Lite (Began April 2008 - Closed) |
| Phase V (Elevate Posterior InteXen, US only) | – | Device: AMS Elevate™ Apical & Posteiror with IntXen LPAMS Elevate™ Apical \& Posteiror with IntXen LP (Began April 2008 - Closed) |
| Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only) | – | Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed) |
| Phase VII (Elevate Anterior Gen 2, US & EU) | – | Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 2, Began April 2009 - Closed) |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult females ages > 21 years old requiring surgical repair of their genital prolapse
Key inclusion criteria (1 listed)
- -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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMS Apogee™ with InteProMesh implant for posterior wall pelvic organ prolapse | Device | Phase I (IntePro, US only) |
| AMS Apogee™ with Intexen LPGraft implant for posterior wall pelvic organ prolapse | Device | Phase I (InteXen LP, US only) |
| AMS Perigee™ with InteProMesh implant for anterior wall pelvic organ prolapse | Device | Phase II (France only) |
| AMS Perigee™ with IntePro LiteMesh implant for anterior wall pelvic organ prolapse | Device | Phase III/IV (Perigee IntePro Lite, US only) |
| AMS Apogee™ with IntePro LiteMesh implant for posterior wall pelvic organ prolapse | Device | Phase III/IV (Apogee IntePro Lite, US only) |
| AMS Elevate™ Apical & Posteiror with IntePro LiteMesh implant for apical and posterior wall pelvic organ prolapse | Device | Phase V (Elevate Posterior IntePro Lite, US & EU) |
| AMS Elevate™ Apical & Posteiror with IntXen LPGraft implant for apical and posterior wall pelvic organ prolapse | Device | Phase V (Elevate Posterior InteXen, US only) |
| AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)Mesh implant for anteiror and apical wall pelvic organ prolapse | Device | Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only) |
| AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)Mesh implant for anteiror and apical wall pelvic organ prolapse | Device | Phase VII (Elevate Anterior Gen 2, US & EU) |
Primary outcome
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.
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.
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.
38 secondary outcomes
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
Procedural Time
Time frame: Approximately 30 minutes
Estimated Blood Loss
Time frame: Approximately 30 minutes
Percent of Subjects Experiencing Major Device Related Complications
Time frame: Through 24 months
Rate of Graft Extrusions
Time frame: Through 24 months
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Time frame: Through 24 months
Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure
Time frame: baseline and 6 weeks
Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
Time frame: 6 Months
Surgical Revision Rate
Time frame: Through 24 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months
Time frame: 6 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months
Time frame: 24 months
Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
Time frame: 12 months
Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
Time frame: 24 months
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Time frame: 6 months
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Time frame: 12 months
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Time frame: 24 months
Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)
Time frame: 6 months
Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)
Time frame: 12 months
Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)
Time frame: 24 months
Wong-Baker Faces Pain Scale at 3 Months Post Procedure
Time frame: baseline and 3 months
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure
Time frame: 6 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure
Time frame: 24 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure
Time frame: 6 months
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22419354Lukban JC, Roovers JP, Vandrie DM, Erickson T, Zylstra S, Patel MP, Moore RD. Single-incision apical and posterior mesh repair: 1-year prospective outcomes. Int Urogynecol J. 2012 Oct;23(10):1413-9. doi: 10.1007/s00192-012-1692-4. Epub 2012 Mar 15.
- Results publication: PubMed 22190952Lukban JC, Beyer RD, Moore RD. Incidence of extrusion following type I polypropylene mesh "kit" repairs in the correction of pelvic organ prolapse. Obstet Gynecol Int. 2012;2012:354897. doi: 10.1155/2012/354897. Epub 2011 Dec 10.
- Results publication: PubMed 22572917Moore RD, Lukban JC. Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse. Int Urogynecol J. 2012 Oct;23(10):1379-86. doi: 10.1007/s00192-012-1744-9. Epub 2012 May 10.
- Derived from this study: PubMed 41204973Schmidbauer L, Liedl B, Goeschen K, Antoniewicz A, Kurtzman J, Wenk MJ. Coexistence of Pelvic Pain, Bladder, and Bowel Symptoms in Women with Pelvic Organ Prolapse: The Effect of Transvaginal Surgery. Int Urogynecol J. 2026 Mar;37(3):691-698. doi: 10.1007/s00192-025-06348-y. Epub 2025 Nov 8.
- Derived from this study: PubMed 38153429Liedl B, Barba M, Wenk M. [Pelvic floor reconstruction-update 2024: prolapse-associated symptoms and their treatment]. Urologie. 2024 Jan;63(1):43-50. doi: 10.1007/s00120-023-02247-6. Epub 2023 Dec 28. German.
- Derived from this study: PubMed 35347368Himmler M, Gottl K, Witczak M, Yassouridis A, Gold DM, Liedl B. The impact of transvaginal, mesh-augmented level one apical repair on anorectal dysfunction due to pelvic organ prolapse. Int Urogynecol J. 2022 Nov;33(11):3261-3273. doi: 10.1007/s00192-022-05151-3. Epub 2022 Mar 28.
- AMS websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C. Lukban, DO principal investigator
Eastern Virginia Medical School
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by ASTORA Women's Health at 28 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, Germany, Belgium, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00638235, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.