Pelvic Floor Repair Systems for Prolapse Repair

Launched by ASTORA WOMEN'S HEALTH · Mar 18, 2008

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

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).