Procedures and Treatments

Disease Segments

Benign Prostatic Hyperplasia

Prostate Cancer

Urinary Incontinence

Stones

Market Value vs. Procedures

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BPH

Stone

Prostate Cancer

Urodynamics/ Urinary Incontinence

Benign Prostatic Hyperplasia (BPH)

Cause• Natural aging process

Results

• Prostate enlarges Bladder wall thickens and bladder weakens

Effects• Frequent Urination and Reduced Urine Flow

Long-Term

• Acute urinary retention

• Urinary Tract Infections (UTI)

• Bladder or Kidney Damage

• Stones and Incontinence

Prostate Cancer

Leading Non-Dermal Cancer among men

Prostate Cancer Rates Increase Exponentially with Age

Not easy to differentiate between BPH with prostate-specific antigen (PSA) tests

Urinary Incontinence

• Involuntary leakage of UrineDefinition

• Stress Incontinence: physical pressure (sneeze/cough)

• Urge Incontinence: involuntary contraction of the muscular wall causes urinary urgency

• Overflow Incontinence: inability to empty bladder

• Mixed Incontinence: stress & urge

• Functional Incontinence: difficulties in thinking, moving or communicating

Types

StonesBladder

• Bladder not emptied completely and remaining urine crystallizes

Kidney

• Substances that are normally dissolved in the urine concentrate together and aggregate into stones

Conditions that Can Cause Stones

• Enlarged Prostate

• Recurring Urinary Tract Infections

Procedures: BPHWatchful Waiting

• Preferred management strategy for patients with mild symptoms

• Appropriate option for men with moderate to severe symptoms without complications

Drug Therapy

• Alpha blockers: terazosin, doxazosin (Cardura), tamsulosin (Flomax), alfuzosin (Uroxatral) and silodosin (Rapaflo)

• 5 alpha reductaseinhibitors: finasteride(Proscar) and dutasteride(Avodart)

• Combination drug therapy

• Tadalafil (Cialis)

Interventional Treatments

• Transurethral resection of the prostate (TURP)

• Transurethral incision of the prostate (TUIP or TIP)

• Open prostatectomy: largely abandoned now for BPH treatment

• Minimally invasive surgery:

• Transurethral microwave thermotherapy (TUMT)

• Transurethral needle ablation (TUNA)

• Laser BPH

• Prostatic stents

TURP (90 mins; 1-3 electrodes/procedure ave of 1.4)

Description Devices

Resectoscope inserted through urethra Resectoscope

Obstructing prostate tissue removed Electrocautery devices

Electrodes:

One pole at surgical site one at patient's backside

Monopolar resection

Monopolar vaporization

Monopolar hybrid

Both poles on electrode itself, current never passes through patient

Bipolar resection

TUIP (less time than TURP; can be performed on outpatient basis)

DescriptionDevices (similar to

TURP)

Combined visual and surgical instrument inserted through penis and urethra

Resectoscope

1-2 cuts made at bladder neck to open channel

Electrical loop or laser and wire loop

End of procedure Catheter

TUMT (min. invasive; treats symptoms not the cause; 1 hr; NOT SUITABLE for prostates > 50 mm in length or 70 g in volume)

Description DevicesMicrowave catheter is inserted into the bladder and anchored in place

Foley balloon; transrectalultrasound

Targeted portion of the prostate is

heated to a temperature over 111°

Fahrenheit (44° Celsius) using

microwaves

Catheter with

microwave antenna

End of procedureTemporary stents (Optional)

TUNA (30 - 45 mins; overnight stay in hospital; likely to require another surgery later)

Description Devices

Interstitial radiofrequency (RF)

needles are inserted through the

urethra and placed in the lateral

lobes of the prostate gland

Cystoscope

The tissue is then heated with low

levels of radiofrequency energy

Two needle electrodes using catheter

End of procedurreTemporary stents (Optional)

Prostatic Stents

For immediate relief of BPH symptoms or patients unsuitable for surgery/anesthesia

Stent placed in correct position Cystoscope

Temporary stents (biodegradable)No catheter required

Permanent stents (used less often; lower success rate to improve symptoms)

Catheter

Laser BPH

Photo-selective Vaporization

(PVP): 20-60 mins

Fiber optic device inserted through

cystoscope

Potassium TitanylPhospate (KTP) lasers

Lithium Triborate(LBO) lasers

Diode lasers

Holmium Laser Ablation (HoLAP)

Holmium: Yttrium-Almuninum-Garnet

(Ho:YAG) lasers

Thulium:Yag lasers

Holmium Laser Resection (HoLRP)

Uses modified continuous-flow

resectoscope with circular fiber guide in

tip

Similar lasers to HoLAP

Holmium Laser Enucleation

(HoLEP)

More advanced than HoLRP and uses wider,

fewer strokes

Outpatient procedure takes < 60 minutes

Interstitial Laser Coagulation (ILC)

Outpatient offices

Laser fiber transurethrally

advanced into prostate

bursts of low-power energy to coagulate and destroy excess

prostate tissue

Diode lasers

Visual Laser Ablation (VLAP)

uses a side-firing neodymium: yttrium-

aluminum-garnet (Nd:YAG) laser

Resectoscope positions laser in prostatic

urethra

Prostatic tissue coagulated

Laser BoxDisposable Laser Fiber

System

Laser Fibers Reusable or Disposable

Propriety to manufacturer’s laser capital equipment

2011: 77.1% of total market for laser BPH attributable to disposable laser fiber market

Procedures: Prostate CancerTest

• Prostate-Specific Antigen (PSA) test

• Digital Rectal Exam

• MRI

• CT

• Biopsy

• FDA submission: ProUroScan® –Elasticity Imaging Technology

Treatment

• Watchful waiting

• Open & Laparoscopic Surgery

• Brachytherapy

• Cryotherapy

• External Beam Radiation Therapy (EBRT)

• High Intensity Focused Ultrasound (HIFU)

• Robotic Prostatectomy

Brachytherapy Outpatient procedure (more targeted than EBRT):

Needle (one per procedure) is inserted through the perineum and radioactive seeds are implanted into the prostate and left inside prostate for up to several weeks to destroy tumor cells.

Fluoroscopy and ultrasound are used to visualize the prostate gland for precise positioning of the needles

Three types of radioactive seeds: Iodine Palladium (shorter half-life than iodine isotopes) Cesium (shortest half-life but new)

High dose radiation (HDR) brachytherapy: Tiny catheters are placed in the prostate and single radioactive iridium-

192 seeds are inserted with the use of a computer allowing for varied radiation doses.

Temporary insertion of radioactive seeds withdrawn after treatment complete

Not modeled in detail in last report

Cryotherapy Minimally invasive surgical procedure

Tumor cells ablated by induction of extremely cold temperatures

Suitable for early stage prostate cancer

Can be repeated if ablation fails unlike brachytherapy

Prostate monitored with transrectal

ultrasound probe

Multiple needles inserted into prostate

through perineum

Gas (usually Argon), injected into prostate

Concurrently: Foley catheter inserted

through urethra into bladder so warm saline solution circulates to protect surrounding

tissue

Cryotherapy Equipment Capital Equipment (~463 installed base with 57

replacement units). ASP ~$127,730

Disposables: 6-8 or 15-20 probes per procedure depending on manufacturer

2011: Duopoly Healthtronic and Galil Medical

External Beam Radiation Therapy Non-invasive procedure used for the treatment of

prostate cancer in its early stages (few mins/treatment carried out over 6-8 weeks)

Can be performed in outpatient settings using high-energy X-ray radiation to damage DNA of the prostate cancer cells

Three common forms of external radiation Intensity-modulated radiation therapy (IMRT)

Proton beam therapy

Three-dimensional conformal radiation therapy (3D-CRT).

EBRT Radiation FormsIMRT

• CT image of tumor

• Combination intensity-modulated fields maximize radiation to tumor

• Minimizes radiation to adjacent tissue

• Next level up: Image guided radiation therapy (IGRT)

Proton Beam Therapy

• Uses protons to kills prostate cancer cells as opposed to radiation

• Minimizes radiation to adjacent tissue

3D -CRT

• Special CT scan and computer to determine the exact location of the prostate and surrounding structure

• Urethra receives a lower dose of radiation than other EBRT treatments

• Anterior rectal wall receives a higher dose

Duopoly: Varian Medical Systems and Siemens

HIFU Minimally invasive: uses precisely focused ultrasound

to heat and ablate prostatic tissue

Performed as outpatient operation under local anesthesia

Takes 2 to 4 hours; usually performed once but can be repeated

Sonatherm is the only HIFU system 510(k) cleared for the laparoscopic or intraoperative ablation of soft tissue as of this year

Robotic Prostatectomy As of 2011: da Vinci® robot by Intuitive Surgical

becoming standard of care

Controlled articulated robotic system with highly sophisticated robotic arms that assist in minimally invasive surgical procedures

Purchased primarily by larger facilities that perform many procedures and will benefit from the assistance of a surgical robotic system

Unit sales revenue: ($933.6 million)

Service Revenue: ($260.8 million)

Bladder Cancer Fulguration Transurethral resection of bladder tumors (TURBT)

Common surgical procedure to treat multiple types of bladder cancer

Cystoscopeinserted through

urethra into bladder

Electrode with wire loop

inserted (same electrodes as

TURP)

High-Frequency

electric current passed

Procedures: UrodynamicsUrodynamic Testing: Computerized evaluation of the body's functions during episodes of incontinence

Catheter will be placed to evaluate the amount of urine in the bladder after voiding rate & flow

Cystoscopy may be required after the urodynamic procedure

Urodynamic Tests Uroflowmetry: Can be performed in private clinic Postvoid residual measurement: Ultrasound or Catheter Cystometric test: Catheter with pressure-measuring device,

manometer, is used Leak point pressure measurement: Catheter & Manometer Pressure flow study: Health care provider’s office, clinic, or

hospital with local anesthesia. Electromyography: Uses special sensors; performed by a specially

trained technician in a health care provider’s office, outpatient clinic, or hospital

Video Urodynamic tests: takes pictures and videos of the bladder during filling and emptying. The imaging equipment may use x rays or ultrasound.

Urodynamic Equipment

Capital Disposables Description

Hospitals (High End)

Air-Charged Catheters

Air-charged catheters transmit changes in pressure through a small volume of air in the catheter

Outpatient Offices (Low to Mid)

Water-Filled Catheters

These catheters are used with external pressure tranducers to detect the frequency and rate of pressure changes in the bladder

Fiber Optic Catheters

Attached transducer tipped catheters.

Urinary Incontinence Treatment Devices

Urinary Catheters

• Intermittent

• Foley

• Male External

Urethral Bulking Agents

• Female Incont.

• Male Incont.

Urinary Incontinence Slings

• Synthetic

• Non-Synthetic

• Sling Anchors

Urinary Catheters Description: hollow plastic or rubber tubes that are

inserted into the urethra for the collection of urine for patients with urinary dysfunction

Intermittent

• Short-term

• Segments:

• Conventional

• Closed System

• Antimicrobial

Foley

• Long-term

• Retained by balloon tip inflated with water

• Segments:

• Stand alone

• Conventional

• Antimicrobial

• Trays

• Conventional

• Antimicrobial

Male External

• Devices that fit over the penis and connect to a drainage bag.

Urethral Bulking Agent Description: hydrogel composed of a biocompatible

recombinant protein polymer that is injected into the periurethral or transurethral route in order to treat stress urinary incontinence

Bulking agents treat urinary incontinence by increasing the tissue bulk around the urethra, thus increasing the resistance to urinary outflow

Urinary Incontinence Slings Devices inserted into the body to treat incontinence

symptoms

This procedure is predominantly performed on females and male sling procedures are performed on a much smaller number of patients

Sling placed around the urethra to lift it to a position where sufficient urethral compression will achieve urine control.

Nephrostomy Procedure that allows for the drainage of urine from

the upper part of the urinary system by puncturing the skin and inserting a catheter at the renal pelvis

Performed whenever a blockage occurs between the kidneys and the bladder, preventing the normal flow of urine from the kidneys, ureters and bladder

Urinary and Kidney Stone Removal Procedures

Extracorporeal Shock Wave

Lithotripsy (ESWL)

Shockwave outside disintegrates stones

Uses ultrasound lithotripter

Non-invasive, outpatient

procedure takes 1 hour

IntracorporealShock Wave

Lithotripsy (ISWL)

Shockwaves inside body

Uses ureteroscopeand lithotripter

Minimally invasive for patients

unsuitable for ultrasound

PercutaneousNephrolithotomy

(PCNL)

Removes stones from urinary tract

PCN needle and guidewire passed into kidney then

fluroscopy confirms needle position

Nephroscope passed through tract into kidney and small stones taken out

ISWL Procedure Steps

Nephroscope locates stone

Stone fragmented

Laser lithotripter

Laser energy via laser fiber inserted through endoscope

Electrohydrauliclithotripter

Probe inserted through endoscope

which delivers shockwaves

Ultrasound lithotripter

Generator produces

mechanical vibrations

Advantage: pieces can be removed using a basket or grasper to decrease recovery time. Stone fragment retrieval device basket devices

Ureteral stent often required

after shockwave therapy

Uses Cystoscope

Pneumatic lithotripsy lithotripsy in which a rigid energy probe is inserted

through the ureter and pneumatic pressure is applied directly to the stone.

Cook Medical

Boston Scientific

PCNL for stone removal Procedure of choice for treating large renal stones

Needle inserted into kidneys

Imaging techniques (CT or

Ultrasound) to help guide needle

Guidewireinserted and nephrostomy

catheter implanted

Drainage catheter set

NephrostomyBalloon Dilation

Catheters

NephrostomyDevice

Urological Endoscopes

• Endoscopy of urinary bladder

• Segments: Rigid & FlexibleCystoscopes

• Examining of ureter

• Common for stone removal

• Segments: Semi-Rigid & FlexibleUreteroscopes

• Most often used in TURP but also to remove lesions in bladder, prostate or urethraResectoscopes

• Used to examine kidneys

• Stone fragment removal baskets inserted through scope

Nephroscopes