Transcript with a click. - Minnesota Women`s Care

A Practical Approach To
Urogynecology
Who Cares? Is this
Really important?
• Incontinence affects 33 million
Americans (17% of the population)
• Direct costs to USA in 2000: $19.5
Billion dollars
• Significant Adverse effects in multiple
quality of life domains
Barriers to
Treatment
Women develop coping
mechanisms like the avoidance
of activities that provoke the
leakage, wearing dark clothes,
avoiding intercouse, and social
interactions with others.
Barriers to
Treatment
•
•
•
•
Normal part of aging
Nothing can be done
Surgical treatment is invasive
Catheters and daily management
products are the best solutions
Incontinence
Myths
DON’T CALL A PLUMBER!!!!!
They’re too expensive!
Barriers to
Treatment
• Feeling of not being equipped to
offer effective solutions
• “ I do not have the time”
• Feeling that incontinence is a
“lost leader”
• Belief that urinary incontinece
just isn’t a serious concern
What is Incontinence?
• Loss of voluntary control over your urinary
functions
• May consist of the loss of a few drops of
urine while coughing or laughing, or urine
loss with a sudden urge to urinate
Classification of Incontinence
• Stress – loss of urine when the
abdomen is under physical stress (e.g.
coughing, laughing, sneezing, running)
• Urge – a sudden, strong urge to urinate
combined with a sudden, uncontrollable
leakage of urine (OVER ACTIVE
BLADDER)
Classification of Incontinence
• Mixed (stress and urge)
• Overflow – frequent or constant
dribble of urine
Transient Incontinence:
DIAPPERS
D
I
A
P
P
E
R
S
Delirium or Acute Confusion
Infection
Atrophic Vaginitis
Phamacologic Agents
Psychotic Disorders
Excessive Urine output (CHF)
Restricted Mobility
Stool Impaction
Consider with Frail and Elderly Women
Secondary Causes
Interstitial Cystitis
Multiple Sclerosis
Parkinson’s Disease
Diabetes Mellitus and Insipidus
Bladder Cancer
Urethral Diverticulum
Fistula
Lifestyle Factors
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Caffeine
Alcohol
Opiods
Sedentary
Cigarette Smoking
Predisposing Factors
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Vaginal Delivery
Age
Genetics
Obesity
Prior Surgery
Chronic Lung Disease/Smoking
Medications
Evaluation of Pelvic Floor
Disorders
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History
Physical Examination
Bedside Simple Cystometry
Determination of Post Void Residual
Supine and Standing Stress Test
Urinalysis
Indications for Complex
Urodynamic Evaluation
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Planning Surgery
Mixed or confusing picture
History inconsistent with Exam
Elevated Post Void Residuals
Failed Conservative Treatment
History of Prior Pelvic floor Surgery
History of Pelvic Radiation
Other Tests
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Voiding Diary
Urine Cytology
Cystoscopy
Electrophysiologic Testing
Radiologic Imaging of Pelvic Floor
Signs of Complicated
Incontinence
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Recurrent Incontinence
Continuous Leakage
Treatment Failure
Prolapse Beyond Hymen
Elevated Post Void Residual
Pain, Hematuria, Recurrent UTI
History of Prior Pelvic floor Surgery
History of Pelvic Radiation
How Does
Stress Incontinence Occur?
How Does
Stress Incontinence Occur?
• Weak Connective Tissue Supports
• Weak Musculature of pelvic floor
• Weakening of the bladder neck
spinchter
• Abnormal nervous system
T
Treatments for Stress
Incontinence
•
Alpha Agonists *
• Tricyclic Antidepressants*
• Urethral Bulking Agents
• Active use of Kegel with Provocative Event
• Catheters/Absorbent Products/Mechanical
Devices
• EXMI Chair
• Surgery
*non FDA Approved Indication
Surgery
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•
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•
Burch Retropubic Colposuspension
Needle Suspension Procedures
Kelly Plication
Traditional Pubovaginal Sling
Highly effective minimally invasive sling surgery
now available
Traditional Approach to Surgical Management
Of Urinary Stress Incontinence
No Hypermobility
Normal Pressure Urethra
Burch
Hypermobility
Sling
ISD
No Hypermobility
Periurethral
Bulking Agents
Principles of Action
TVT
Kohli N, Miklos J, Lucente V. Tension-free vaginal tape: A minimally invasive
technique for treating female SUI. Contemporary OB/GYN; Gynecare reprint: 1 – 10.
Trans-Obturator Approach
• Easy to implant
– Operative time is
reduced
• Minimally invasive
• Local, regional or
general anesthesia
can be utilized
Bladder pressure
The Micturition Cycle
Bladder filling
Storage
phase
Emptying
phase
Normal desire to
First sensation tovoid
void
Bladder filling
Innervation of the LUT
Inferior mesenteric ganglion
Sympathetic
Trigone
Urethra
Parasympathetic
T10-L2
Somatic
S2-S4
Adapted from Abrams P, Wein AJ. The Overactive Bladder:
A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998.
External
urethral
sphincter
Muscles of the
pelvic floor
Distribution of Cholinergic and
Adrenergic Receptors in the
Μ = Muscarinic
LUT
Ν = Nicotinic
α = α1-adrenergic
β = β2-adrenergic
Detrusor
muscle (M,β)
Pelvic floor (N)
Trigone (α)
Bladder neck (α)
Urethra (α)
Adapted from Abrams P, Wein AJ. The Overactive Bladder:
A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998.
Characteristic
Symptoms of OAB
• Frequency
and
• Urgency
• Urge incontinence
Bladder pressure
greater than urethral
pressure
Treatment: Lifestyle Changes
Avoid Bladder Irritants
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•
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•
•
Caffeine
Alcohol
Chocolate
Cigarettes
Acidic/Spicy foods
Treatment: Lifestyle Changes
Fluid Management:Avoid
Excess intake
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•
•
Drink 6-8 cups of fluids/day
Drink throughout day instead of
“binge”
Drink most of fluid in day and
afternoon
Avoid excessive restriction:
concentrated urine
Treatment: Lifestyle Changes
Evaluate contributing
Factors:
•
•
Medications
Avoid Constipation: Add Fiber to Diet
• Obesity
Treatment: Lifestyle Changes
Medications affect Bladder
Function by:
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•
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Decreasing Bladder Contractility
Increasing Bladder Contractility
Increasing Urethral Sphincter Tone
Decreasing Urethral Sphincter Tone
Treatment: Lifestyle Changes
Medications that Decrease
Bladder Contractility
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Anticholinergics
Beta-adrenergic Agonists
Calcium Channel Blockers
Alcohol (Also act as ADH inhibitor)
Antihistamines, sedatives, narcotics
Antidepressants
Antipsychotics
Treatment: Lifestyle Changes
Medications that increase
detrussor irritability/diuresis
•
•
•
Diuretics
Caffeine
Alcohol
Treatment: Lifestyle Changes
Medications increase Urethral
Sphincter Tone:
•
•
•
Alpha-Adrenergic Agonists
Amphetamines
Tricyclic Antidepressants
Treatment: Lifestyle Changes
Medications that Decrease
Urethral Sphincter Tone:
•
Alpha-Adrenergic Blockers
Behavioral Modification
Education
Pelvic floor
exercises
Timed
voiding
Behavioral
Modification
Reinforcement
Delayed
voiding
Pelvic Floor
Excercises
• Self management program utilizing the Kegel
technique or pelvic muscle exercises
• May not see an improvement in bladder control
for up to 3 to 6 weeks
• May be improved with Biofeedback or Electical
Stimulation
Bladder
Retraining
• Best with management of urinary frequency
and urgency
• Goal is to trick the bladder into thinking that it
is always empty in an effort to regain voluntary
control over bladder emptying.
When the Urge Strikes!
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Stop and stay still
Squeeze pelvic floor muscles
Relax rest of body
Concentrate on suppressing urge
Wait until the urge subsides
Walk to bathroom at normal pace
Limitations of Behavior
and Lifestyle Changes
• Require motivation in both patient
and Provider
• Success depends on intensity of
program
• High cost in terms of Provider
time
Treatments for Over Active
Bladder
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Behavioral Therapy
Pelvic Floor Rehabilitation (Kegels)
Biofeedback
Electrical Stimulation
Neuromodulation (Interstim, Tibial
Nerve Stimulation)
Botox Bladder injections
Medications
Medications for Over Active
Bladder
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Tolterodine
Oxybutynin (oral and Patch)
Darifenacin
Troposium
Solifenacin
Neurotransmitter Receptors
Adrenergic
Receptors
Cholinergic
Receptors
Nicotinic
Muscarinic
α-Adrenergic
Subtypes
M1, M2, M3,
M4, M5
Adapted from Wein AJ. Exp Opin Invest Drugs. 2001;10:65-83.
β-Adrenergic
Muscarinic Receptor
Distribution
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M1 : Neural Tissue
M2: Detrussor, Cardiac
M3: Detrussor, Salivary Glands
and Bowel
M4: Cerbral Cortex, Lungs
Why Treat OAB
with
Antimuscarinics
• Detrusor contraction in the
normal bladder is primarily
mediated via muscarinic
receptors
– release acetylcholine from
cholinergic nerves
– stimulation of muscarinic receptors
on the detrusor smooth muscle
Clinical Effects of
Antimuscarinic Therapy
• Stabilizing effect on bladder (detrusor) muscle
• Diminishes frequency of involuntary bladder
contractions
• Increases functional bladder capacity
• Delays initial urge to void
Considerations in Choosing
Anticholinergic Medications
• Provides efficacy by inhibiting involuntary
bladder contractions
• Does not prevent normal micturitions
• Is selective for the bladder over other
organs, resulting in reduced side effects and
improved tolerability
• Provides clinical effectiveness—the optimal
balance of efficacy, tolerability, and
compliance/persistency
Distribution of Muscarinic Receptors in
Target Organs of the Parasympathetic
Nervous System
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•
•
DizzinessCNS
Somnolence
Impaired
Memory & Cognition
Iris/Ciliary Body = Blurred Vision
Lacrimal Gland = Dry Eyes
Salivary Glands = Dry Mouth
Heart = Tachycardia
Gall Bladder
Stomach = Dyspepsia
Colon = Constipation
Muscarinic receptors are
also located in the CNS.
Bladder (detrusor muscle)
Adapted from Abrams P, Wein AJ. The Overactive Bladder:
A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998.
Contraindications for
Anticholinergics
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Renal Failure
Hepatic Failure
Narrow Angle Gluacoma
Gastric Retention
History of an Allergic Reaction
Medication Failures
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Tolerability of side effects
Lack of efficacy
High rate of noncompliance
Drug Therapy Persistence is Poor
Among OAB Patients
100%
100%
88%
Prescription persistency rates of OAB
medications among patients new to
market (n=21,362)
80%
60%
44%
40%
34%
28%
15%
20%
Initial Rx
1st Refill
2nd Refill
3rd Refill
4th Refill
11th Refill

56% of patients chose not to refill their prescription a second time

Only 15% of patients continued with their therapy through the first year
Source: The 2002 Gallup Study of the Market for Prescription Incontinence Medication. Princeton, NJ: Multi-Sponsor Surveys, Inc 2002
InterStim Therapy
Sacral Nerve Stimulation for Urinary Control
Sacral nerve
stimulation provides
an effective alternative
for voiding dysfunction
patients who have not
been helped- or could
not tolerate- more
conventional
treatments, including
pharmacotherapy.
InterStim® Therapy
 Utilizes mild electrical pulses to the nerves associated
with voiding function. Through neurostimulation,
significantly improved or normal voiding is restored.
History of Sacral Nerve
Stimulation
•
1981 – Department of Urology, University of California at San
Francisco initiated clinical program.
•
1985-1992 – Multi-center trial conducted by Urosystems, Inc.
•
1994 – Medtronic CE mark (approval to market in Europe) for
InterStim Therapy in Europe for treatment of urge incontinence,
retention and urgency-frequency.
•
September 1997 – FDA grants Medtronic approval of the InterStim
System for treatment of urge incontinence in the US.
•
April 1999 - FDA approval of the InterStim System for treatment of
symptoms of urgency-frequency and urinary retention.
•
September 2002 – FDA approval of tined lead
•
August 2005 – Over 21,000 patients implanted worldwide
Who Can Benefit from InterStim
Therapy?
• Patients whose symptoms did not improve
with more conventional treatments, such
as medications
• Patients with non-obstructive urinary
retention
• Patients with symptoms of overactive
bladder, including urinary urge
incontinence and urgency-frequency
• Patients who cannot tolerate the side
effects from medications
Benefits of InterStim
Therapy
• Effective Treatment in properly
screened patients
• Safe
• Reversible
• Does not preclude use of alternative
treatments
Test Stimulation Procedure
• A test is done prior to
implant to determine
how a patient will
respond to the
implanted device
• Performed in the office
or surgery center
• A lead is surgically
implanted near the S3
nerve
• Lead is connected to an
external device worn on
the patient’s belt for a
period of 3-7 days
• Patient will record
his/her voiding behavior
in a diary
Test Stimulation
Procedure
• Locate & identify sacral nerves
• Verify neural integrity
• Allow the patient to feel the
stimulation
• Assess viability of sacral nerve
stimulation on
voiding behavior (goal is
efficacy > 50% improvement in
symptoms)
• Help physician & patient make
an informed choice about the
long-term therapeutic value
Test Stimulation Procedure
Video
Test Stimulation (click to start and pause video)
Implant Procedure
• After successful test
stimulation, the
physician may
implant the InterStim
System
• A pocket is typically
created for the
neurostimulator in
the upper buttock
Tined Lead
Model #3889 shown, Model #3093 not shown
Using the Tined Lead with the Lead Introducer
(CLICK ON THE PICTURE TO BEGIN THE VIDEO, CLICK CONTINUE & RESUME IF PROMPTED)
If the animation takes too long to download, you can find the same graphic
On the tined lead CD.
Contraindications to Interstim
Therapy
•
•
•
•
Failure to respond by more than 50%
to test stimulation
Outlet Obstruction
Patient without mental capacity to
manage device
Bladder Cancer
Patient Programmer
• Patient is given a
programmer to control
the settings on their own
without visiting his/her
physician or nurse
• Allows patient to turn the
device on and off, and
adjust the levels of
stimulation within
physician-set limits
Clinical Study Overview
• Multi-center randomized, prospective study*
– 23 centers: 9 European & 14 North American
– 581 patients (1993 – 1998)
• Measurements:
– Urge incontinence
• Number of leaking episodes /day
• Severity of leaking episodes
• Number of pads/diapers replaced/day
– Urgency-frequency
• Number of voids/day
• Volume voided/void
• Degree of urgency prior to void
– Retention
• Volume per catheterization
* Staged Implant was not performed during this study
Data (MDT-103): 1993 - 1998
Efficacy: Overactive Bladder
Data (MDT-103): 1993 - 1998
Efficacy: Urinary Retention
Data (MDT-103): 1993 - 1998
Implantation:
Ranking of Adverse Events in
First 12 Months Post-implant
• Pain at neurostimulator site
15.3%
• New pain
9.0%
• Suspected lead migration
8.4%
• Infection
6.1%
• Transient electric shock
5.5%
• Pain at lead site
5.4%
• Adverse change in bowel function
3.0%
Note: Additional events occurred – each less than 2.0%
Data (MDT-103): 1993 - 1998
InterStim® Therapy:
Healthcare Utilization 1 year Before & After Implant
Kaiser Permanente® Healthcare System1
N=65 patients
PreImplant
Mean
Post
Implant
Mean
Mean
Change
P Value
Voiding Related
Diagnostic &
Therapeutic
Procedures
1.03
0.06
-1.0
procedures
<0.0001
Urinary Tract
Infections
0.43
0.24
-0.19 UTIs
0.0959
Outpatient Visits
3.02
0.82
-2.3 visits
<0.0001
Outpatient Costs
$994
$265
-$729
<0.0001
Procedure Costs
$655
$59
-$596
<0.0001
Drug Expenditures
$693
$483
-$210
0.021
1.
• After one year
73% of
patients
indicated an
improvement
of 50% or
greater
• Outpatient
visits and
costs were
reduced by
73%
• Annual drug
Aboseif, S. et al. Sacral Neuromodulation: Cost Considerations and Clinical Benefits. expenditures
Manuscript Pending Acceptance. 2006
were reduced
Quality of Life




Patients implanted with InterStim System reported significantly
improved ratings (p < 0.00625) in health-related quality of life (HRQOL)
measures.1
The largest gain was noted in the subject’s perceived ability to
increase their level of work performance or other daily activity. 1
An improvement of 10% to 40% in Beck Depression Inventory scores
has been shown in urge incontinent patients.2
Improved results in both (HRQOL & depression) have been seen at
three months and sustained for a 12-month period of follow-up.1
1 Das, A.K. et al. Improvement in Depression and Health-Related Quality of Life After Sacral Nerve
Stimulation Therapy for Treatment of Voiding Dysfunction. Urology 64: 62-68, 2004.
2. Shaker, H.S. and Hassouna, M. Sacral Nerve Root Modulation: An Effective Treatment for Refractory Urge
Incontinence. J Urol, 159: 1516, 1998
Patient Selection: Who Benefits Most?
Patients who are most likely to discontinue drug therapy
may have the best chance for remaining completely dry
100%
3.5
3
Adjusted Odds Ratio of age as a
predictor of treatment drug
discontinuation1
90%
InterStim Therapy Patients with no
daily leakage episodes2
80%
2.5
70%
2
60%
65%
50%
1.5
37%
40%
1
0
(referent)
0.5
30%
18-39 40-49 50-59 60-69 70+
20%
10%
0%
Younger than 55
Older than 55
1. Campbell, U.B, Stang, P, Barron, R, Galt Associates, Inc., Allergan, Inc. Survey Assessment of Compliance and
Satisfaction with Treatment for Urinary Incontinence. Poster Presentation, ICS Conference, 2005
2. Amundsen, C.L. et al. Sacral Neuromodulation for Intractable Urge Incontinence: Are There Factors Associated With Cure?
Urology 66: 746-750 2005.
Summary
 Patients are more often prescribed medical therapy and
polypharmacy before further treatment options, such as
InterStim Therapy, are discussed
 Because of the challenging compliance issues associated with
medical management, patients may be placed in a cycle of
being a “perpetual new patient” often discontinuing the
healthcare system or accepting their condition before InterStim
Therapy is presented to them
 Randomized controlled trials may confirm long term results vs.
more conservative treatments
 InterStim Therapy is an effective treatment option in the
treatment of voiding dysfunction, offering not only sustained
results, but may also provide significant economic & quality of
life considerations to payors and patients