Society Perspective: Pelvic Organ - PowerPoint Presentation

Slide1

Society Perspective: Pelvic Organ Prolapse Registries

Catherine Bradley, MD September 7, 2018

OutlineBackgroundPelvic Organ Prolapse

– BackgroundMesh in POP SurgeryAUGS Registry Experience – the Pelvic Floor Disorders Registry (PFDR)

Accomplishments

Lessons learned

POP research

questions

What are pelvic floor disorders (PFDs)?

Interrelated clinical conditions:Pelvic organ prolapse (POP)Urinary incontinence (UI)Fecal incontinence (FI)Emptying abnormalities of the lower urinary and GI

tracts

Almost 25% of all women and more than 1 of 3 older women report symptoms of at least one

PFD

(Nygaard, JAMA 2008

)

1 in 7 women will undergo POP surgery by age 80

(Wu,

ObGyn

, 2014)

Pelvic Organ Prolapse (POP)Descent of the pelvic organs into or through the vagina

Often accompanied by:Vaginal bulgingUrinary symptomsBowel symptomsSexual dysfunction

3

%-6% of

women have POP (vaginal/uterine descent) beyond

the

vaginal opening

15-17% of all hysterectomies done for POP; most common indication for hysterectomy in postmenopausal women

POP TreatmentNon-surgicalObservation, Behavioral modifications

Pelvic floor muscle exercisesPessarySurgicalTransvaginal

Native tissue repair

Transvaginal

Mesh

Abdominal or Laparoscopic/Robotic

Sacrocolpopexy (includes mesh)

Obliterative (vaginal closure or colpocleisis)

POP Repair Surgeries - US Market 2010*

300,000 women

*industry source

Transvaginal Mesh - Events

2008

FDA Public Health Notification

2008

AUGS

began

exploring development of POP registry

July

2011

FDA Updated

Safety Communication

on Transvaginal Mesh

for POP

Sept 2011 FDA Advisory

Panel convened

Nov 2011 AUGS Strategic Planning Meeting – POP

registry

development high priority for Society

Jan 2012 522 Orders

Surgeons performing transvaginal placement of mesh for POP should undergo training specific to each device and have experience with reconstructive surgical procedures

and a thorough understanding of pelvic anatomy.Transvaginal placement of mesh for POP should be

reserved for high-risk individuals in whom the benefits of mesh placement may justify the

ri

sk...

ACOG & AUGS strongly support continued audit and review of outcomes, as well as the

development of a registry for surveillance for all current and future vaginal mesh implants

.

Transvaginal Mesh/FDA

Jan 2012: FDA

ordered

postmarket

surveillance studies (

“

522 studies

”

) by manufacturers of urogynecologic surgical mesh

devices

RCT

or prospective cohort recommended with comparison to transvaginal surgery without mesh (

“

native tissue

”

)

Amenable

to facilitating multi-sponsor

registry

POP Outcomes Registry - Development

Collaborative effortAUGS registry leadership and experts on content, research design, and implementation

Industry partners, FDA, NICHD, ACOG, Women’s Health Registry Alliance, PFDN Advisory Panel, SUFU, AUA

Consensus on data collected

Outcomes

Shared native tissue control group

Shared non-surgical group

What is the PFDR?Multiple POP treatment registries/databases

Designed to

collect prospective data

from patients

undergoing treatment for pelvic organ prolapse (POP)

Intended to collect both provider and patient reported

outcomes

PFDR

Objectives

Evaluate

effectiveness

,

QOL and

safety

of POP surgery

Assess

effectiveness

and

QOL associated

with non-surgical management (pessary)

of

POP

Provide a framework for clinical studies to be conducted within the registry, including industry-sponsored studies required to fulfill the FDA

’

s request for

postmarketing

surveillance for transvaginal mesh for

POP

Allow surgeons to track

patients, outcomes, adverse events,

q

uality measures

What did we accomplish?

DevelopmentData Access/Legal AgreementsCommon core dataset and

protocol

Shared native tissue

group

Common primary outcome, adverse outcomes

~700 common data elements

Functioning database

Scope

4

Industry

Partners: 7 protocols (522)

AUGS Quality and Research protocols

PFD Registry -

Timeline

Legal agreements - 2012

D

ata

collection and database requirements

2012-2013

User

acceptance testing

2013

Launch

Industry protocols 2014

AUGS quality/research protocols 2015

PFDR – Current Stats

4 active Industry protocols1 active AUGS Research protocolEnrollment ended, 3-year follow-up ongoing> 700 total PFDR sites> 3500 total PFDR participants

AUGS Research Registry

11 active sites

1,159 participants

820 Surgery

339 Pessary

PFDR Challenges - DevelopmentCollaboration of “Rivals”

Making a Registry Platform also function/meet requirements for a pre-market approval study9 protocols (7 industry-sponsored, AUGS research, AUGS quality)Thousands of volunteer hours

PFDR Challenges – Use, LongevityDouble data entry

Difficult/costly to make changes in platformMaximizing patient participation Long-term patient follow-upLong-term funding

POP Registry PlanningMore focused objective for POP core minimum datasetDevice effectiveness, safetyQuality measure requirements

Opportunity for modular expansion Research questions that require more detailed data collectionChanges in device indications

Direct data collection from electronic medical record

User-friendly platform

High Priority POP Research QuestionsSurgical factors:

Does a concomitant hysterectomy impact outcomes?Are native tissue repairs really equivalent to mesh repairs in terms of durability?

When

is an apical prolapse repair absolutely necessary?

Patient factors:

What patient factors will modify risks and recurrence rates?

What outcomes best match the patient experience

?

Surgeon factors:

Does

fellowship training make a difference in

outcomes

?