genital prolapse pelvic organ prolapse
Conditions
Interventions
None listed
Sponsors
American Medical Systems
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: These include females who: 1) 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 2) Are > 21 years old
Exclusion criteria
Exclusion criteria: 1) The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse. 2) Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed. 3) Subject has active or latent systemic infection or signs of tissue necrosis. 4) Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis. 5) 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. 6) Subject has had radiation therapy to the pelvic area. 7) Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months. 8) Subject has a known hypersensitivity to the graft material(s). 9) Subject has uncontrolled diabetes. 10) Subject is on any medication which could result in compromised immune response, such as immune modulators. 11) Subject was involved in any other research trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects with an ICS POP-Q Stage of | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Quality of Life (QoL) status * defined as the improvement in subjects* QoL over baseline values for: * Pelvic Floor Distress Inventory (PFDI) to assess the impact of urinary, prolapse and colorectal distress at 6, 12 and 24 months. * Pelvic Floor Impact Questionnaire (PFIQ-7) to assess the life impact of pelvic floor disorders at 6, 12 and 24 months post procedure. * Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire- short form (PISQ-12) to assess the sexual function associated with genital prolapse at 6, 12, and 24 months post procedure. 2) Procedural Time * defined as the time between the first incision to place the specific prolapse device to the last appendage pull through (with or without lateral attachments) and closure of the vaginal incision for the specific prolapse device. 3) Estimated Blood Loss (EBL) * defined as the estimated blood loss associated with each specific AMS PFR System device for prolapse repair during the entire implant procedure. 4) Percent of subjects experiencing major device-related complications, such as the following: * Perforation of the internal organs (excluding the bladder) during the implant procedure * Graft erosion (away from the vagina) through the wall of bladder, bowel, rectum or urethra causing clinical complications * Graft extrusion (into the vagina) resulting in major treatment (surgical revision or excision) * Serious infection requiring intravenous (IV) antibiotics * Death, related to procedure or device * Blood loss related to device placement requiring blood transfusion during AMS PFR device- related portion(s) of the procedure 5) Rate of Graft Extrusion of AMS PFR System devices for prolapse repair * defined as graft exposure/protrusion through the vaginal wall. Graft extrusion will be classified by the type of treatment received (i.e., no treatment, non-invasive treatment (oral and/or topical medication only), minor treatment (cautery with AgNO3, electrocautery, or | — |
Countries
Netherlands
Outcome results
None listed