Clinical trial NCT00638235: Pelvic Floor Repair Systems for Prolapse Repair
Official title: A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic floor repair
prolapse
mesh
Lead sponsor: ASTORA Women's Health
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 725
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females ages \> 21 years old requiring surgical repair of their genital prolapse

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
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
timeFrame: 12-months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure
timeFrame: 12-months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure
timeFrame: 12-months
Secondary outcomes:
measure: QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
timeFrame: 6 Months
measure: Procedural Time
timeFrame: Approximately 30 minutes
measure: Estimated Blood Loss
timeFrame: Approximately 30 minutes
measure: Percent of Subjects Experiencing Major Device Related Complications
timeFrame: Through 24 months
measure: Rate of Graft Extrusions
timeFrame: Through 24 months
measure: Rates of de Novo or Worsening Urinary and/or Anal Incontinence
timeFrame: Through 24 months
measure: Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure
timeFrame: baseline and 6 weeks
measure: Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
timeFrame: 6 Months
measure: Surgical Revision Rate
timeFrame: Through 24 months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months
timeFrame: 6 months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months
timeFrame: 24 months
measure: Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
timeFrame: 12 months
measure: Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
timeFrame: 24 months
measure: Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
timeFrame: 6 months
measure: Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
timeFrame: 12 months
measure: Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
timeFrame: 24 months
measure: Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)
timeFrame: 6 months
measure: Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)
timeFrame: 12 months
measure: Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)
timeFrame: 24 months
measure: Wong-Baker Faces Pain Scale at 3 Months Post Procedure
timeFrame: baseline and 3 months
measure: QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
timeFrame: 12 months
measure: QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
timeFrame: baseline and 24 months
measure: QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M
timeFrame: baseline and 6 months
measure: QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M
timeFrame: baseline and 12 months
measure: QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M
timeFrame: baseline and 24 months
measure: 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
timeFrame: baseline and 6 months
measure: QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M
timeFrame: baseline and 12 months
measure: QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M
timeFrame: baseline and 24 months
measure: QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M
timeFrame: baseline and 6 months
measure: QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M
timeFrame: baseline and 6 months
measure: QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M
timeFrame: baseline and 12 months
measure: QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M
timeFrame: baseline and 24 months
measure: QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M
timeFrame: baseline and 12 months
measure: QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M
timeFrame: baseline and 24 months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure
timeFrame: 6 months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure
timeFrame: 24 months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure
timeFrame: 6 months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure
timeFrame: 24 months
Other outcomes:
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure
timeFrame: 6 months
measure: Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure
timeFrame: 24 months
Locations:
city: Downey
country: United States
facility: Kaiser Permanente - Dept. of Obstetrics & Gynecology
state: California
city: Wellington
country: United States
facility: Institute for Women's Health & Body
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark Womencare Specialists
state: Idaho
city: Portland
country: United States
facility: Fore River Urology
state: Maine
city: Portland
country: United States
facility: Maine Medical Partners
state: Maine
city: Whitinsville
country: United States
facility: Female Pelvic Health
state: Massachusetts
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine and Urogynecology Inst. of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Michigan Medical P.C.
state: Michigan
city: Paw Paw
country: United States
facility: Women's Health Care Specialists, PC
state: Michigan
city: Plymouth
country: United States
facility: Metro Urology
state: Minnesota
city: Gastonia
country: United States
facility: Piedmont Urology Associates
state: North Carolina
city: Englewood
country: United States
facility: Huey & Weprin Obstetrics & Gynecology
state: Ohio
city: Columbia
country: United States
facility: South Carolina OB/GYN
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee - Dept of Obstetrics & Gynecology
state: Tennessee
city: El Paso
country: United States
facility: Texas Tech University Health Science Center - OB/GYN Department
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Leuven
country: Belgium
facility: UZ Leuven Dept of Urology
city: Montpellier
country: France
facility: CMC Beau Soleil
city: Paris
country: France
facility: Service urologie de Paris l'Hôpital Tenon
city: Paris
country: France
facility: Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest
city: Rouen
country: France
facility: CHU de Rouen - Pavillon Derocque - Rez de Chaussée
city: Strasbourg
country: France
facility: Clinique Adassa
city: Alzey
country: Germany
facility: Dr. Rainer Lange
city: Munich
country: Germany
facility: Beckenbodenzentrum Munich
city: Amsterdam
country: Netherlands
facility: University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics
city: Barcelona
country: Spain
facility: Hospitalet General de l'Hospitalet
city: Leicester
country: United Kingdom
facility: University Hospital of Leicester NHS Trust
Study officials:
affiliation: Eastern Virginia Medical School
name: James C. Lukban, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.