Long-term evaluation of efficacy and safety of the AMS Pelvic Floor Repair System devices for prolapse repair
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percent of subjects with an ICS POP-Q Stage of < Stage I at one year post
procedure
Secondary outcome
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 trimming), or major treatment (surgical
revision/graft excision). Location of extrusion and timing of diagnosis will
also be collected. Graft extrusion resulting in major treatment will be
reported with major device-related complications.
6) Rate, onset and type of de novo or worsening urinary and/or anal
incontinence
7) Interval POP-Q Staging: POP-Q staging at 6 and 24 months post procedure --
defined by the percent of subjects with an ICS POP-Q Stage of < Stage I at 6
and 24 months post procedure.
8) Pain -- defined as the level of pain or discomfort associated with the
pelvic area experienced and measured at baseline and 6 weeks and 3 months post
procedure using the Wong-Baker Faces Pain Scale.
9) Subject satisfaction with experience and outcomes of the procedure, as
reported on Patient Satisfaction Questionnaires at 6, 12 and 24 months
post-procedure.
10) Rate of Surgical Revision* percent of subjects who return to the operating
room for adjustment or removal of an AMS PFR System device(s) for prolapse
repair.
Background summary
All the products to be studied within this trial have received market clearance
from the United States Food and Drug Administration (FDA). Product improvements
and iterations may be introduced into the study upon availability as they are
cleared by the FDA with notification sent to study sites as applicable.
Study objective
Long-term evaluation of efficacy and safety of the AMS Pelvic Floor Repair
System devices for prolapse repair
Study design
Prospective mult-centre observational study
Study burden and risks
None (no invasive outcome measurements are performed)
10700 Bren Road West
Minnetonka, MN 55343
Verenigde Staten
10700 Bren Road West
Minnetonka, MN 55343
Verenigde Staten
Listed location countries
Age
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
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 < 30 days of enrollment into this
study.
12) Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this
study.
13) Subject is unwilling or unable to give valid informed consent.
14) 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.
15) Subject is contraindicated based on intended use and warnings in the AMS PFR
System devices for prolapse repair Instructions for Use (IFU).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22550.018.08 |