Running an Intracavernosal Injection Program

(1)

Running

an

Intracavernosal

Running

an

Intracavernosal

Injection

Program

Injection

Program

Jeffrey Albaugh, PhD, APRN, CUCNS

[email protected]

NorthShore University Healthcare

System, IL

Director of Sexual Health

Jesse Brown VA Medical Center Sexual

Health Program, IL

Joseph Narus, DNP, APRN, NP‐BC

[email protected]

Male Sexual & Reproductive Medicine

Program

(2)

Disclosures



Jeffrey

Albaugh,

PhD,

APRN,

CUCNS

None



Joseph

Narus,

DNP,

APRN,

NP

‐

BC

None

(3)

Objectives



_Injection

_Training



_Medications:

_Selection

_&

_Titration



_Prolonged

_{Erections/Priapism}

(4)

MKSCC

Training

MKSCC

Training

 Managed by 2 Advanced Practice Registered Nurses

(APRNs)

 Training visits reimbursable

• 1st visit billed as CPT (54235), ICD‐9 (607.84)

• 2nd _Visit_billed_as_CPT_(99213),_ICD_‐₉_(607.84)

 Approximately 400 patients trained annually

 Approximately 2,000 patients actively injecting in

practice

 Patients follow‐up with APRNs every 5‐6 months for

first two years post‐RP, long‐term follow‐up q 2 yrs

(5)

NorthShore

University

HealthCare

and

Jesse

NorthShore

University

HealthCare

and

Jesse

Brown

VA

Brown

VA

 Managed by 1 Advanced Practice Registered

Nurse (APRN)

 Approximately 150 patients trained annually

 Approximately 500 patients actively injecting in

practice

 _Patients_follow_‐_up_with_APRN_every₆_‐₁₂_months

for as long as they are injecting (more often if

(6)

 Scheduled for 1‐2 sessions with adequate time

for all instructions (typically 30‐60 minutes)

• Instructed not to take PDE5i night before or day

of visit

• Reminded to bring corrective reading lenses

• Encouraged to bring spouse or partner

 Provided verbal, video (if applicable) and written

instructions

 Teaching sessions also involve one‐on‐one training

going through each step of the process and having

the patient/significant other return demonstrate

every step of the process giving the first injection

(7)

 Injection supplies:

• Vial of Normal Saline

• Syringe (29 gauge, ½”needle, 50

unit/0.5cc )

• Alcohol swabs

• Sharps container

• Pre‐filled syringe

 Instructed on drawing

medication from multi‐dose vial

 Taught to rotate injection sites

& what to do if problems occur (i.e.

(8)

Anatomical landmarks • Avoid visible veins

• Do not twist or rotate penis – accidental urethral injection

Deep dorsal vein

Dorsal penile nerve

Corpus spongiosum Urethra Corpus cavernosum Cavernosal artery Tunica albuginea Dartos fascia Buck's fascia Dorsal penile artery

(9)

 Patient grasps glans

with less dominant

hand (must retract

foreskin if

uncircumcised) and

gently stretch penis

 Area to be injected

located and

swabbed with

alcohol wipe

 Holding needle as

dart or pen position

toward area to be

(10)

 Touching needle to injection

site, swiftly slide entire length of

needle through tunica albuginea

into cavernosal tissue

 Medication instilled into

cavernosal tissue by depressing

plunger

 Needle swiftly removed

 Direct pressure held with alcohol

swab to site for 3–5 minutes,

(11)

Response

 Patient informed may experience warm

sensation within 3‐5 minutes followed by

“stretching”, “tight”, or “heavy” non‐

painful sensation along shaft

 Rigidity should occur within 10‐20 minutes

with minimal stimulation

 Erection scale used to grade

• 0 = no erection

• 6 = erection just firm enough for penetration

• 8‐10 = Satisfactory for sexual intercourse

(12)

Monitoring

 Contacts office reporting result after first home

injection for titration instructions

 Injects 2‐3x/week regardless of sexual activity

 If poor or no response cannot repeat for 24 hrs

 No PDE5 Inhibitor within 18‐36 hours of ICI

 _May_take_multiple_injections₂_‐_3x/week_to

reach appropriate dose1

 Follow‐up scheduled 5‐6 months or sooner for

additional teaching session if required

12 1Albaugh & Ferrans, 2009. Impact of Injections on Men with Erectile dysfunction

(13)

Medication

Selection

Medication

Selection

• 1982 Virag demonstrated intracavernosal

injection of papaverine produced rigid erection.

Followed by Brindley 1983, but issues with

fibrosis nodules and side effects as single agent.

• Ultimately used lower doses in combination of

vasoactive medications including most commonly

papaverine, phentolamine, alprostadil and/or

atropine directly into the corpus cavernosum [Zorgniotti, A.W. & Lefleur, R.S. (1985). Autoinjection of the corpus cavernosum with vasoactive drug

combinationi for vasogenic impotence. J Urol 133, 39‐41; Goldstein, I. et al. (1990) Rescuing the failed papaverine/phentolamine erection: a proposed synergistic action of papaverine,

phentolamine and prostaglandin E1. J Urol, 143, 204A]

• Utilized when first‐line therapy not effective or side

(14)

Selecting an Injection Agent

Selecting

an

Injection

Agent

 FDA approved medications may have

better insurance coverage and if

appropriate should be considered

 Reasons for using compounded

medications

• Less Pain

• Less Cost

• Greater Efficacy

• Availability

Albaugh, J. (2006). Intracavernosal injection algorithm. Urologic Nursing. Baniel, J., et al. (2000). Three‐ year outcome of a progressive treatment… Urology. WHO International Society for Impotence

Research. (2000). Table 9‐3 Incidence of pain with Trimix. In: Erectile Dysfunction, Health Publication

(15)

 Papaverine

• Vasodilator, smooth muscle spasmolytic producing generalized

smooth muscle relaxation (PDE Inhibitor) ‐drug has longest half

life

 Phentolamine

• Non‐selective ‐adrenoceptor blocker, completely blocks ‐

adrenergic receptors to produce brief antagonism of circulating

epinephrine and norepinephrine

 PGE1/Alprostadil (Caverject®_,_Edex®₎

• Prostaglandin (PGE₁). Relaxes trabecular smooth muscle by

dilation of cavernosal arteries promoting arterial flow and

blood entrapment within the lacunar spaces of the penis

 Compounded multi‐agent mixtures (Bimix, Trimix,

(16)

FDA

‐

_‐

Approved

_Approved

Injectable

_Injectable

PGE

_PGE

₁



Edex

®

/

Viridal

®

:

• 10 mcg • 20 mcg • 40 mcg



Caverject

®

:

Solution (reconstituted) • 20 mcg • 40 mcg 16

(17)

Compounded

Mixtures

Compounded

Mixtures



Papaverine

• Papaverine 30 mg/ml



Bimix

 Papaverine 30 mg/ml  Phentolamine 1‐1.5 mg/ml



Trimix

 Papaverine 30 mg/ml  Phentolamine 1 mg/ml  PGE₁10 mcg/ml



“Super

Trimix”

 Papaverine 30 mg/ml  Phentolamine 2 mg/ml  PGE₁ 20 mcg/ml



“Quadmix”

 Papaverine 30 mg/ml  Phentolamine 2 mg/ml  PGE₁ 20 mcg/ml  Atropine 0.15 mg/ml

(18)

Choosing a Compounding Pharmacy

Choosing

a

Compounding

Pharmacy

 All compounding pharmacies are not created

equally

• Are the compounded medications tested randomly

and routinely for accuracy and by whom?

• Are they accredited or what standards do they

adhere to?

Governed by FDA and State Board of Pharmacies

FDA: Shelf‐life ≤ 6 mos; no compounding commercially

available products solely for cost

Pharmacy Compounding Accreditation Board (PCAB)

website http://www.pcab.org/prescribers

(19)

Titration

(20)

(21)

Precautions

 Obese abdomen

 History vaso‐vagal

response  Dexterity problems  Uncontrolled hypertension  Predisposition to priapism due to hematologic disorders

(e.g., sickle cell anemia,

multiple myeloma, leukemia) – www.caverject.com/prescribingInfo.aspx – http://www.edex.com/filebin/pdf/Edex_Ful

Contraindications

 Concurrent use of MAO

Inhibitors

 Penile prosthesis

 Sexual activity is

inadvisable or

(22)

Advantages

 High efficacy rate

 Reliable

 Suitable for travel but

agents with PGE₁

requires refrigeration

Disadvantages

 Invasiveness and

anxiety of injecting

needle into penis

 Cost/insurance coverage  Side effects: • Priapism • Bruising/bleeding • Hematoma • PGE₁ pain

 Papaverine may test (+)

for opiates on urine

screen1

Albaugh (2010) Urological Nursing, 30, 167-177.

1_{Pierpaoli & Mulhall (1998).}_{Journal of Urology}_{, 159, 1299}_.

(23)

Priapism

 0.5–11.3% incidence1 (0.2% MSKCC)

 Ischemic in nature

 Post‐training education on management

essential (Wallet instruction card)

 Off label pseudoephedrine 30 mg (1‐2 tablets‐ if

they can take this medication‐ anecdotal support

from patients) or terbutaline 5 mg (1‐2 tablets;

this medication has limited research support)2

1_{Sundaram et al. (1997)}_Urology_{, 49, 932; Padma‐Nathan et al, (1986),}_{World Journal of Urology}_{, 160, 1752. Claro Jde et}_,

al. (2001) Sao Paulo Medical Journal

2_{Priyadarshi, S. (2004). Oral terbutaline in…}_Int_{Jour of Imp Research}_{, 16, 424‐426. Lowe, F.C. & Jarow, J.P. (1993).}

(24)

Management of Prolonged Erection

Management

of

Prolonged

Erection

 Instructed to take 2‐4 tablets of

pseudoephedrine (Sudafed®) 30mg if erection 6

or firmer > two hours

 Erection remains ≥ 6/10 at third hour after

pseudoephedrine, patient contacts office

 By fourth hour, at Emergency Department for

intracavernosal injection of phenylephrine (Neo‐

Synephrine®). ER contacted by provider.

 If unresponsive to phenylephrine will need to

aspirate blood

(25)

Aspiration of Priapism

Aspiration

of

Priapism

• AUA guidelines for phenylephrine or irrigation:

http://www.auanet.org/content/guidelines‐and‐

quality‐care/clinical‐

guidelines.cfm?sub=priapism

• Phenylephrine safe and effect in limited trials;

Muruve, N. & Hosking, D.H. (1996).

Intracorporeal Phenylephrine…Journal of

Urology, 155, 141‐143. Dittrich, A., Albrecht, K.,

Bar‐Moshe, O. & Vandendris, M. (1991).

Treatment of pharmacological priapism

(26)

Aspiration of Priapism

Aspiration

of

Priapism

 Kit: • Phenylephrine 10,000 mcg/ml vial • 10ml of Normal Saline • (10,000 mcg Phenylephrine + 9 ml NS = 1,000 mcg/ml solution)

• 19 gauge butterfly needle

• 5 ml syringe • 10‐30ml syringe • Basin • 4x4 & 2x2 gauges • Coban 26

(27)

FAQs

 Can I use a smaller needle?

 Can I use an injection and pill together?

 Why have injections stopped working?

 _I_have_pain_with_an_injection_of_Alprostadil?

Why is that? What can I do to prevent it?

 _How_can_I_travel_with_my_medication?

 Can I use a mirror to inject, as I cannot see my

penis?

 Why does the injection work on the right side

and not the left side?

(28)

 How do I dispose of the needles?

 I’m a doctor, why do I need two training visits?

 Does my health insurance cover the cost of the

medication?

 I have a tremor, can I be trained to inject?

 _Can_I_inject_more_than₃_times_a_week?

 Is it safe to resume injections if it has been 6

months since my last injection?

 Can I do injections if I have extensive Peyronie’s

disease?

 _Can_I_use_injections_if_I_am_taking_anti_‐

coagulants?

(29)

Pain:

Needle

and

Medication

Pain:

Needle

and

Medication

 Albaugh & Ferrans (2009) (n=65)

• 40% (n = 26) no pain with the needle insertion

• Those with pain (n=39) from needle insertion

Mean injection pain score = 1.33 (SD = 0.63); range of 0.5 to

3.0

• Medication pain occurred in 35% (n = 23)

• For those with pain, the mean pain rating was 2.6 (SD =

1.27) (range 0‐10) with reports of pain ranging from

0.5‐5

• A comparison of men who had radical prostatectomy

(n = 27) with those who had not (n = 38) revealed:

A significantly larger proportion of post radical prostatectomy

men experienced pain from the medication (51.9% vs 23.7%)

[χ2(1, n = 65) = 5.5, p = .02]

29

(30)

Needle

Insertion

Pain

and

Anxiety

Needle

Insertion

Pain

and

Anxiety

 Nelson, et al, (2009) (n=127)

• Pain and anxiety with use measured at two training

sessions and 4‐month follow‐up

• No significant difference in men who scored ≤ 2 vs. > 2

on pain scale at 1st _training_session_(59%_vs._41%) compared to 4 month follow‐up (53% vs. 47%)

• Mean injection pain score = 2.2±1.8 (range 0‐10) (SD

= 0.63); range of 0.5 to 3.0

• Mean injection anxiety score at 1st _injection_was

5.7±2.8 (range 0‐10) and significantly decreased to

4.1±3 at 4 months (p<00.1)

30

Nelson, et al. (2009). Anxiety, pain, depression and sexual self‐esteem in men using intracavernosal injection therapy for erectile dysfunction following radical pelvic surgery. Abstract SMSNA Conference, San Diego, CA.

(31)

Injections

and

Quality

of

Life

Injections

and

Quality

of

Life

Post

‐

prostatectomy

 Erectile function improved

• Erection strength Mean at 1 month = 7.75 (SD = 1.80);

3 months = 7.47 (SD = 1.68)

• Mean erection strength at 1 and 3 months ‐ both over

the 7/10 strength threshold indicating erection rigid

enough for sexual relations.

 Overall Self Esteem and Relationship (SEAR) scores

and the scores for the sub‐domains for sexual

relationship and sexual confidence improved

significantly from baseline to one month and three

months1‐2_.

(32)

Benefits

to

Injections

Benefits

to

Injections

 Penile injections effective associated with improved

satisfaction with sexual relationship and improved

sexual confidence and self‐esteem1

 Erections can last after orgasm

 Patient’s reported advantages of: quick & easy, less

messy; more natural erection without rings2

32 1_{Albaugh & Ferrans, 2009. Impact of Injections on Men with Erectile dysfunction after}

prostatectomy. Urologic Nursing, 30(1), 64‐77. 2_{Soderdahl, D.W., Thrasher, J.B. & Hansberry, K.L}

(33)

Barriers

to

Injections

Barriers

to

Injections

 Reasons for dropping out of self‐injection program (n=720)1_:

• Too expensive 28.3%

• Did not like idea of injecting penis 27.6%

• Partner did not like injections 19.3%

• Partner not available 17.0%

• Erections improved spontaneously 15.3%

• Not effective 14.2%

• Development of penile curvature 11.2%

• Development of other medical problems 10.6%

• Lost interest in sex 8.1%

• Undertook alternative treatment 7.6%

• Lost interest in partner 7.2%

• Developed penile lump 5.8%

• Injections thought to be unnatural 6.1%

• Erections lasted too long 4.9%

• Injections painful 4.9%

• Fear of needles 4.5%

33 1_{Mulhall , et al. (1999). The causes of patient drop‐out from penile self‐injection therapy for impotence.}

(34)

Conclusions: Injections

Conclusions:

Injections

Pros: They Work!

• Improve Erections, Self‐Confidence, Relationship

• Highly Effective

Cons:

• Anxiety, Pain, Priapism

(35)