Pelvic Floor Repair Systems for Prolapse Repair

NCT00638235 | Completed Results

• 1 other identifier: 1004
• Study Type: observational
• Target: 725
• Locations: 7 countries
• Sites: 28

Brief Summary

1. 1.This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
2. 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. 3.The study population is female subjects \> 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
4. 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. 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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic floor repair; prolapse; mesh

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  6 Months

• Procedural Time

  Approximately 30 minutes

• Estimated Blood Loss

  Approximately 30 minutes

• Percent of Subjects Experiencing Major Device Related Complications

  Through 24 months

• Rate of Graft Extrusions

  Through 24 months

Other Outcomes (2)

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

  6 months

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

  24 months

Study Arms (9)

Phase I (IntePro, US only)

AMS Apogee™ with IntePro(Began May 2006 - Closed)

Device: AMS Apogee™ with IntePro

Phase I (InteXen LP, US only)

AMS Apogee™ with InteXen LP (Began May 2006 - Closed)

Device: AMS Apogee™ with Intexen LP

Phase II (France only)

AMS Perigee™ with IntePro (Began February 2007 - Closed)

Device: AMS Perigee™ with IntePro

Phase III/IV (Perigee IntePro Lite, US only)

AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)

Device: AMS Perigee™ with IntePro Lite

Phase III/IV (Apogee IntePro Lite, US only)

AMS Apogee™ with IntePro Lite (Began April 2007 - Closed)

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)

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)

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)

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)

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

Interventions

AMS Apogee™ with IntePro DEVICE

Mesh implant for posterior wall pelvic organ prolapse

Phase I (IntePro, US only)

AMS Apogee™ with Intexen LP DEVICE

Graft implant for posterior wall pelvic organ prolapse

Phase I (InteXen LP, US only)

AMS Perigee™ with IntePro DEVICE

Mesh implant for anterior wall pelvic organ prolapse

Phase II (France only)

AMS Perigee™ with IntePro Lite DEVICE

Mesh implant for anterior wall pelvic organ prolapse

Phase III/IV (Perigee IntePro Lite, US only)

AMS Apogee™ with IntePro Lite DEVICE

Mesh implant for posterior wall pelvic organ prolapse

Phase III/IV (Apogee IntePro Lite, US only)

AMS Elevate™ Apical & Posteiror with IntePro Lite DEVICE

Mesh implant for apical and posterior wall pelvic organ prolapse

Phase V (Elevate Posterior IntePro Lite, US & EU)

AMS Elevate™ Apical & Posteiror with IntXen LP DEVICE

Graft implant for apical and posterior wall pelvic organ prolapse

Phase V (Elevate Posterior InteXen, US only)

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

Mesh implant for anteiror and apical wall pelvic organ prolapse

Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only)

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

Mesh implant for anteiror and apical wall pelvic organ prolapse

Phase VII (Elevate Anterior Gen 2, US & EU)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult females ages \> 21 years old requiring surgical repair of their genital prolapse

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• ASTORA Women's Health: lead

Study Sites (28)

Kaiser Permanente - Dept. of Obstetrics & Gynecology

Downey, California, 90242, United States

Location

Institute for Women's Health & Body

Wellington, Florida, 33414, United States

Location

Atlanta Medical Research Institute

Alpharetta, Georgia, 30005, United States

Location

Rosemark Womencare Specialists

Idaho Falls, Idaho, 83404, United States

Location

Fore River Urology

Portland, Maine, 04102, United States

Location

Maine Medical Partners

Portland, Maine, 04102, United States

Location

Female Pelvic Health

Whitinsville, Massachusetts, 01588, United States

Location

Female Pelvic Medicine and Urogynecology Inst. of Michigan

Grand Rapids, Michigan, 49503, United States

Location

Michigan Medical P.C.

Grand Rapids, Michigan, 49546, United States

Location

Women's Health Care Specialists, PC

Paw Paw, Michigan, 49079, United States

Location

Metro Urology

Plymouth, Minnesota, 55441, United States

Location

Piedmont Urology Associates

Gastonia, North Carolina, 28054, United States

Location

Huey & Weprin Obstetrics & Gynecology

Englewood, Ohio, 45322, United States

Location

South Carolina OB/GYN

Columbia, South Carolina, 29201, United States

Location

University of Tennessee - Dept of Obstetrics & Gynecology

Memphis, Tennessee, 38103, United States

Location

Texas Tech University Health Science Center - OB/GYN Department

El Paso, Texas, 79905, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

UZ Leuven Dept of Urology

Leuven, Belgium

Location

CMC Beau Soleil

Montpellier, 34070, France

Location

Service urologie de Paris l'Hôpital Tenon

Paris, 75020, France

Location

Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest

Paris, France

Location

CHU de Rouen - Pavillon Derocque - Rez de Chaussée

Rouen, 76031, France

Location

Clinique Adassa

Strasbourg, 67082, France

Location

Dr. Rainer Lange

Alzey, 55232, Germany

Location

Beckenbodenzentrum Munich

Munich, 81679, Germany

Location

University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics

Amsterdam, 1105AZ, Netherlands

Location

Hospitalet General de l'Hospitalet

Barcelona, 08906, Spain

Location

University Hospital of Leicester NHS Trust

Leicester, LE5 4PW, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 22419354 RESULT

• Lukban 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.

  PMID: 22190952 RESULT

• Moore 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.

  PMID: 22572917 RESULT

• Liedl 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.

  PMID: 38153429 DERIVED

• Himmler 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.

  PMID: 35347368 DERIVED

Related Links

• AMS website

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. Ph- II ended before all subjects reached 24M visit b/c the next generation of Perigee was already under trial, Ph-III/IV 2. Ph-VI ended after 12M visit because the next generation of study device was already under clinical evaluation in Phase VII

Results Point of Contact

• Title: Dr. James C Lukban, Professor & Director Division of urogynecology
• Organization: Eastern Virginia Medical School

lukbanjc@evms.edu

7574467900

Study Officials

• James C. Lukban, DO

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 19, 2008
• Study Start: May 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2012
• Last Updated: October 28, 2016
• Results First Posted: October 28, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); GB (1); BE (1); US (17); FR (5); DE (2); ES (1)