Running an Intracavernosal Injection Program

Transcription

1 Running an Intracavernosal Injection Program Jeffrey Albaugh, PhD, APRN, CUCNS NorthShore University Healthcare System, IL Director of Sexual Health Jesse Brown VA Medical Center Sexual Health Program, IL Joseph Narus, DNP, APRN, NP BC Male Sexual & Reproductive Medicine Program Memorial Sloan Kettering Cancer, NY 1

2 Disclosures Jeffrey Albaugh, PhD, APRN, CUCNS None Joseph Narus, DNP, APRN, NP BC None 2

3 Objectives Injection Training Medications: Selection & Titration Prolonged Erections/Priapism Facts and Questions 3

4 MKSCC Training Managed by 2 Advanced Practice Registered Nurses (APRNs) Training visits reimbursable 1st visit billed as CPT (54235), ICD 9 (607.84) 2 nd 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 4

5 NorthShore University HealthCare and Jesse 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 every 6 12 months for as long as they are injecting (more often if needed) 5

6 Scheduled for 1 2 sessions with adequate time for all instructions (typically 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 6

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. prolonged erections) 7

8 Anatomical landmarks Avoid visible veins Do not twist or rotate penis accidental urethral injection Dorsal penile artery Deep dorsal vein Dartos fascia Corpus cavernosum Cavernosal artery Dorsal penile nerve Buck's fascia Corpus spongiosum Urethra Tunica albuginea 8

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 injected 9

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, longer if on anti coagulation 10

11 Response Patient informed may experience warm sensation within 3 5 minutes followed by stretching, tight, or heavy nonpainful sensation along shaft Rigidity should occur within 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 10 = 100% erect 11

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 hours of ICI May take multiple injections 2 3x/week to reach appropriate dose 1 Follow up scheduled 5 6 months or sooner for additional teaching session if required 1Albaugh & Ferrans, Impact of Injections on Men with Erectile dysfunction after prostatectomy. Urologic Nursing, 30(1),

13 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 effects not tolerated 13

14 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). Threeyear 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 14 Ltd.

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 (PGE 1 ). 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, Super Trimix, Quadmix ) 15

16 FDA Approved Approved Injectable PGE 1 Edex / Viridal : 10 mcg 20 mcg 40 mcg Caverject : Solution (reconstituted) 20 mcg 40 mcg 16

17 Compounded Mixtures Papaverine Papaverine 30 mg/ml Bimix Papaverine 30 mg/ml Phentolamine mg/ml Trimix Papaverine 30 mg/ml Phentolamine 1 mg/ml PGE 1 10 mcg/ml Super Trimix Papaverine 30 mg/ml Phentolamine 2 mg/ml PGE 1 20 mcg/ml Quadmix Papaverine 30 mg/ml Phentolamine 2 mg/ml PGE 1 20 mcg/ml Atropine 0.15 mg/ml 17

18 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 18

19 Titration 19

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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) l_prescribing_information.pdf Contraindications Concurrent use of MAO Inhibitors Penile prosthesis Sexual activity is inadvisable or contraindicated 21

22 Advantages High efficacy rate Reliable Suitable for travel but agents with PGE 1 requires refrigeration Albaugh (2010) Urological Nursing, 30, Pierpaoli & Mulhall (1998). Journal of Urology, 159, Disadvantages Invasiveness and anxiety of injecting needle into penis Cost/insurance coverage Side effects: Priapism Bruising/bleeding Hematoma PGE 1 pain Papaverine may test (+) for opiates on urine screen 1 22

23 Priapism % incidence 1 (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, Claro Jde et al. (2001) Sao Paulo Medical Journal 2 Priyadarshi, S. (2004). Oral terbutaline in Int Jour of Imp Research, 16, Lowe, F.C. & Jarow, J.P. (1993). Placebo controlled study of oral terbutaline & pseudoephedrine Urology, 42(1). 23

24 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 24

25 Aspiration of Priapism AUA guidelines for phenylephrine or irrigation: andquality care/clinicalguidelines.cfm?sub=priapism Phenylephrine safe and effect in limited trials; Muruve, N. & Hosking, D.H. (1996). Intracorporeal Phenylephrine Journal of Urology, 155, Dittrich, A., Albrecht, K., Bar Moshe, O. & Vandendris, M. (1991). Treatment of pharmacological priapism with Journal of Urology, 146(2),

26 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? Why can t I get Trimix at my local pharmacy? 27

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 than 3 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 anticoagulants? 28

29 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 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] Albaugh, J.A. & Ferrans, C.E. (2009). Patient reported pain with initial intracavernosal injection. Journal of Sexual Medicine, 6(2),

30 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 1 st 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 1 st injection was 5.7±2.8 (range 0 10) and significantly decreased to 4.1±3 at 4 months (p<00.1) 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. 30

31 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 months Albaugh & Ferrans, (2009). 2 Nelson, et al. (2009). 31

32 Benefits to Injections Penile injections effective associated with improved satisfaction with sexual relationship and improved sexual confidence and self esteem 1 Erections can last after orgasm Patient s reported advantages of: quick & easy, less messy; more natural erection without rings 2 1 Albaugh & Ferrans, Impact of Injections on Men with Erectile dysfunction after prostatectomy. Urologic Nursing, 30(1), Soderdahl, D.W., Thrasher, J.B. & Hansberry, K.L (1997). Brit Journal of Urology, 79(6) 32

33 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% 1 Mulhall, et al. (1999). The causes of patient drop out from penile self injection therapy for impotence. Journal of Urology, 162( ). 33

34 Conclusions: Injections Pros: They Work! Improve Erections, Self Confidence, Relationship Highly Effective Cons: Anxiety, Pain, Priapism 34

35 Thank You 35