us 2014 urology procedure and treatment report
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Procedures and Treatments
Disease Segments
Benign Prostatic Hyperplasia
Prostate Cancer
Urinary Incontinence
Stones
Market Value vs. Procedures
0
500
1000
1500
2000
2500
-200.0 300.0 800.0 1,300.0
Ma
rke
t V
alu
e (
$ m
illi
on
)
Procedures (thousands)
Market Value ($ mil)
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
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