innovative treatment options for pelvic organ prolapse

Innovative Treatment Options for Pelvic Organ

Prolapse

Travis L. Bullock, MD

A condition in which the pelvic organs (bladder, uterus, or rectum) “fall” onto the vaginal wall and in some patients bulge outside the vagina.

A type of “hernia” due to weakening of the muscles and connective tissues of the pelvis.

Affects 50% of women, however only 20% of those women have significant symptoms.

Unfortunately, only about half of these women seek medical help despite a significant impact on their quality of life.

Epidemiology of POP

Epidemiology of POP

One of the most common gynecologic surgeries performed

>500,000 procedures performed annually> $1 Billion spent yearly on surgery

alone11% lifetime risk of surgery by 80yoUp to 30% will have >1 surgery for POP

highlighting the high failure rate of current procedures

Surgery for POP

20-29 30-39 40-49 50-59 60-69 70-790

2

4

6

8

10

12

Projected Female Population

2000 2010 2030 20500

5

10

15

20

25

60-69 yrs70-79 yrs80+ yrs

Population of women >60yo is expected to increase by 72% Women >60yo are more likely to seek care than their younger

counterparts

Prevalence of Pelvic Floor Disorders

50s 60s 70s 80s0

50000

100000

150000

200000

250000

300000

350000

20002030

Demand for services to care for pelvic floor disorders will increase at twice the rate of the growth of the general population!

– Age– Parity– Family history of prolapse (collagen)– Post menopausal state– Repetitive pressure on the pelvis

(constipation, chronic cough, obesity)– Prior pelvic surgery such as hysterectomy. – Caucasian 3X more common than African

American women

Risk Factors

Many women may have no symptoms. More advanced prolapse may experience some or all of the following:

– Vaginal or rectal pressure– You may feel or see a bulge protruding from

the vagina– Difficulty emptying the bladder– Inconsistent urinary stream– Trapping of stool in the rectum– The need to place a finger in the vagina to

empty the bladder or bowel– Vaginal irritation– Low backache– Spotting of blood on the underwear– Recurrent bladder infections

Prolapse Symptoms

Named for the anatomic area or organ prolapsing

– Anterior wall = Cystocele– Posterior wall = Rectocele– Apical Prolapse

EnteroceleUterine prolapseVaginal vault prolapse

Often have more than one type of prolapse

Types of Prolapse

Cystocele

Rectocele

Apical prolapse

Enterocele

Anatomy of Pelvic SupportBoney pelvic

framework Endopelvic fasciaLevator ani

musclesCollagenous

connective tissue attachments to the pelvic side walls

Anatomy of Pelvic Support Level I: Parametrium and

paracolpium (Uterosacral and Cardinal ligaments). Supports the upper 1/3 of vagina

Level II: Direct lateral attachments to the arcus tendineus (pubocervical fascia). Supports the mid 1/3 of vagina

Level III: Vagina fuses with urethra and perineal body. Supports distal 1/3 of vagina.

Evaluation Examine in lithotomy position Standing if degree of prolapse does not

correlate with symptomatology Bottom blade of speculum Valsalva or cough vigorously and note relationship

of pelvic organs Rectovaginal exam Perineal body Vaginal mucosa (atrophy, fissures, ulcers) Incontinence with and without prolapse reduction PVR

Baden-Walker or “Half-way” system

Easy to use and widely understoodMost dependent position of pelvic

organs during maximal straining1st degree

– Half-way to the hymen2nd degree

– To the hymen3rd degree

– Beyond the hymen

Prolapse Grading4 grades popularized by

Raz1: minimal hypermobility

of the bladder2: bladder base to

introitus with straining3: bladder base outside

introitus with straining4: bladder base outside

introitus at rest

POP-QIn 1996 ISC/AUGS developed the POPQStandardized, site specific system to

quantify and classify POPMeasurements at 9 specific sites relative to

the hymenInter-examiner and Intra-examiner

reproducibilityCan be bulky and time consumingUsed mostly for research

Treatment Options for POPNon-surgical

– PFME and Behavioral techniques– Pessary

Surgical– >100 procedures described– Colporrhaphy– Sacrospinous fixation– Mesh augmentation– Sacral Culpopexy

Open Laparoscopic Robotic

Behavioral changes– Weight loss, avoiding heavy lifting, correcting a chronic

cough (quitting smoking), or preventing constipation that contributes to straining to have a bowel movement.

Pelvic floor exercises (Kegels)– Cannot reverse the prolapse, but contracting strong

pelvic floor muscles when lifting or bearing down may prevent pelvic organ prolapse from becoming worse or help relieve symptoms.

Vaginal pessary – the most common non-surgical treatment for prolapse.

Non-surgical Treatment

Worn in the vagina to support prolapsed organ

Must be specially fittedRemoved for periodic

cleaningsMay be associated with

vaginal discharge and erosions

Favorable risk-benefit ratio

Vaginal Pessary

ColporrhaphyPlication of fibromuscular

tissues of vaginal wallMost common prolapse

procedure performedMinimally invasiveMay be associated with

vaginal scaring or shortening

10-70% failure rate, 30% reoperation rate

Sacrospinous Ligament FixationAttachment of the apex of the

vagina to the sacrospinous ligament

Often combined with colporrhaphy

Hysterectomy not always required

Technically challengingExtensive dissection and

retraction may be requiredDeviates the vagina

Mesh AugmentationSubstitute “damaged” tissues

with synthetic materialDecreased recurrence rate as

compared to traditional plication

Easy to perform with familiar trocar passes

Can be associated with pain and erosions if not familiar with the technique

Short term data is favorable, but still maturing

Mesh Augmentation

American Medical Systems– Apogee, Perigee,

ElevateGynecare

– ProliftBard

– AvaultaBoston Scientific

– Pinnacle, Uphold

Sacral Culpopexy“Gold Standard” for uterine and vaginal

vault prolapseA graft if used to suspend the vagina to

the inside of the sacrum Maintains anatomical positionPreserves vaginal axis and maintains

vaginal lengthLow recurrence rateTraditionally performed with an

abdominal incisionCan be completed laparoscopically

using the da Vinci robotic system

Sacral CulpopexyOpen (abdominal)

– Good long-term results: 93-100% success rates with durable repair

– Increased morbidity: invasive mid-line incision leading to prolonged recovery time (5-6 hospital days)

– 5% of all prolapse proceduresLaparoscopic

– Reproduce open approach minimally invasively

– Technically difficult learning curve due to complex suturing and dissection

Now Robotic …

History of Robotics in Medicine

Term “robot” was first coined in 1921 by the Czeck writer Karel Capek is his play Rossum’s Universal Robots

Robota = forced labor

History of Robotics in Medicine

1985-PUMA 560 CT guided brain biopsy

1987-first CCK with robotic assistance

1998-PROBOT for transurethral resection

1992-ROBODOC (Integrated

Surgical Supplies) used in orthopedics

History of Robots in Medicine1993-AESOP (Computer Motion, INC).

First robot approved by the FDA1998-Zeus

– Surgeon control center and 3 robotic arms.

– First fully endoscopic robotic procedure (CABG)

– Computer Motion and Intuitive Surgical merged in June 2003

2000-da Vinci Surgical System.

da Vinci Surgical SystemApproved by the FDA in 2000

for laparoscopic surgerySurgeon console and patient

side robotic cart with 3 or 4 arms

“Master-Slave” surgical systemHigh-Definition 3-D

VisualizationEndoWrist instruments>800 in use in the United States

and EuropeCost = $1.2-1.75 million

Surgeon BenefitsHigh resolution 3D visionEndoWristed Instruments

with 7 degrees of freedomFilters out tremorEnhanced dexterityComfortableEase of suturingShort learning curveOvercomes limitations of traditional laparoscopy

while replicating open approach

Drawbacks with Conventional Laparoscopic Surgery

Surgeon operates from a 2D image

Straight, rigid instruments (limited range of motion)

Reduced dexterity, precision and control

Unsteady camera controlled by assistant

Greater surgeon fatigueMakes complex operations more

difficult

ApplicationsGeneral surgery

– Pancreatectomy, Whipple, Liver resection and Transplantation, CCK, Nissen, Gastric bypass

Cardiothoracic Surgery– CABG, Mitral valve repair, Lung resection

GYN– Hysterectomy, Myomectomy, Oncology

Urology– Prostatectomy, Nephrectomy, Partial Nephrectomy,

Cystectomy, Adrenalectomy, Pyeloplasy, Ureteral Reimplantation, VV fistula, Sacral Culpopexy

da Vinci Sacrocolpopexy

Represents a state-of-the-art minimally invasive approach to surgical correction of vaginal vault or uterine prolapse by resupporting the vagina to the sacrum using a polypropylene mesh.

Preparation Patient Selection

(First 5 cases):

Relatively thin patient (BMI<30)

Healthy with few comorbidites

No or few abdominal surgeries

Reasonable sized uterus, if present

Vaginal vault prolapse before uterine prolapse

Patient PositioningPlace the patient on the table in the supine

position. Pad all bony prominences and employ anti-

skid methods (e.g., vacuum bean bag, etc.) due to moderate to steep Trendelenburg position (>20).

A modified dorsal lithotomy position is utilized; the patient’s legs are separated and flexed using adjustable leg stirrups with boots (e.g., Allen stirrups).

Port Placement and Set-up

Vaginal Manipulation

Vaginal manipulation is necessarySpecial planning is required to maintain intra-

operative access to the vaginal and rectal manipulators:– Use rounded EEA™ (End-to-End Anastomosis)

sizers to manipulate the vagina– An EEA™ sizer in both the vagina (31-33 mm) and

rectum (29 mm) allows for clear identification and easy dissection of the rectovaginal septum

EEA™ sizers from Autosuture™

Develop Anterior Bladder Flap

Develop Rectovaginal space

Polyproplylene Mesh

DurablePermanentPorousNon-immunogenic

Anterior Mesh Placement

Posterior Mesh Attachment

Develop Presacral Space and Locate Anterior Longitudinal Ligament

Adjust Mesh Tension

Attach Mesh to Sacral Promontory

Close Peritoneum

Patient Benefits“Gold Standard”Less invasiveLess painLess scaringLess blood loss and need for

transfusionShorter hospital stayFaster recovery and quicker

return to activities

Robotic Sacrocolpopexy: Results

30 consecutive patients with high-grade apical prolapseGreatly reduced morbidity: patients left the hospital in 1 day as

opposed to 2-5 daysDurability of results equals long-term results of open procedureLow complication rate and high patient satisfactionPotentially, many more women will be able to be offered the

strongest repair of prolapse while minimizing morbidity

Management of Urethra

Significant prolapse may mask SUI due to urethral kinking.

Occult SUI and may be seen in up to 25% of patients

Concomitant sling may be performed based on urodynamics

Conclusions POP is a common condition Demand for treatment is expected to

exponentially increase as the population ages

Treatment options include observation, pessary, or surgery

Colporrhaphy is minimally invasive, but with a high recurrence rate

Mesh vaginal procedures may decrease this risk, but data still maturing

Open Sacral Culpopexy is the “gold standard”, but maximally invasive

Robotic surgery may combine the best of all worlds

Questions?