Chapter 5-Novel Interventions for Low Libido-Pelvic Rejuvenation

What Would Compel an Otherwise Sane Person, or Even a Medical Doctor, to Attend a Lecture at 6:30 A.M. on a Sunday?

Novel Interventions for Low Libido-Pelvic Rejuvenation

1. Pharmaceutical Interventions for Erectile Dysfunction and Vaginal Atrophy

            The “Little Blue Pill”

The “modern” sexual revolution began in 1998 with the FDA approval of sildenafil (Viagra).  Prior to its’ release, the issue of “ED,” erectile dysfunction,” and its diverse manifestations, was rarely discussed in physician offices, let alone the subject of billboards and late night TV comedian jokes.

Overnight it is de rigueur to discuss one’s lack of sexual function and desire.  I distinctly remember, while watching an NFL playoff game with several religious, fundamentalist friends, a commercial with a male and a female sitting in bathtubs on a mountainside.  An advertisement for tadalafil prior to its’ release,  didn’t state the drug’s indication,  but hinted at it with a “wink and a nod.”  When finished, my friends asked what the medication was for.   I danced around the answer as these were not the type of people who would discuss “that” openly.

Fast forward twenty years.  A sporting event not sponsored by a PDE-5 inhibitor manufacturer is a rarity.  Go to any wine bar, restaurant, or club function, and invariably someone discusses their experience with the “little blue pill.”  Carnac the Magnificient himself could not have predicted weak, nonexistent sexual desire and function would transmute into a badge of honor.

Currently, there are four such drugs approved erectile dysfunction:

1. Sildenafil (Viagra: 1998)
2. Tadalafil (Cialis: 2003)
3. Vardenafil (Levitra: 2003)
4. Avanafil (Stendra: 2012)

All PDE-5 inhibitors are taken one-half to 4 hours before sexual intercourse.  Typically, the recommended dose is no more than once daily.

Type-5 phosphodiesterases are isoforms of this enzyme found primarily in the corpus cavernosum of penis and vasculature of the lung.  They block the breakdown of cyclic guanosine monophosphate (cGMP) resulting in prolonged vasodilation in the penis (and lung). ⁽¹⁾  The end result of this action is the prolongation of penile erection and decrease pulmonary vascular pressure.  PDE-5 inhibitors have little effect on the systemic vasculature. ⁽²⁾

⁽³⁾

 They are approved for use in women.

Side effects of PDE-5 inhibitors include headache, flushing, rhinitis, stomach pain, back pain (Cialis), and indigestion.  Patients taking nitrates are at risk for dizziness and a sudden drop in blood pressure. ⁽⁴⁾

There is a less than two percent experience of prolonged or painful erections.  Blurred vision,

increased sensitivity to light, bluish haze and reports are on hand indicating some difficulties distinguishing between blue and green colors are reported. ⁽⁵⁾

Prasterone 6.5 mg

FDA Approved vaginal Insert for moderate to severe pain during sexual intercourse caused by vaginal atrophy after menopause.  The dose is one applicator at bedtime.  Relief is expected in twelve weeks.

Side effects are vaginal discharge and changes in a pap smear.

Estriol: 1mg/ml Compounded Intravaginal Cream or Suppository

Estriol (E3), generated in the placenta, is significantly elevated and aids in maintaining pregnancy,  acts to protect against breast cancer, ⁽⁶⁾  controls the symptoms of menopause, decreases LDL and increases HDL.

A study of 23,000 women treated with (natural) Estradiol and Estriol E3

with or without progestins revealed a risk-ratio of 0.72, i.e., 28% decrease in breast cancer mortality and a risk-ratio of 0.77 (or 23% decrease) in all-cause mortality. ^(7-9)

Topical E3 relieves postmenopausal atrophy, vaginal dryness, and urinary incontinence. It does not have the brain, bone, or heart protection of estradiol.

Dose: 1 ml nightly x 14 nights then 1 ml nightly 3x/wk. x 14 nights then

1 ml as needed.

Side Effects include vaginal irritation, itching, and discharge after application. Vaginal bleeding is an indication of estrogen excess and must be evaluated.

Testosterone 0.5-2.0%: Compounded intravaginally or topically.

A premenopausal woman produces 0.9-2.85 mg of testosterone per day.  Testosterone maintains bone strength, bone density, improves muscle tone and body composition, increases energy and endurance, maintains skin turgor, collagen production, and texture, restores and reinvigorates sexual desire and stabilizes emotional well being.

Testosterone administration to physiologic levels doubles, on average, the number of sexual events per week. ⁽¹⁰⁾ 

Dose: Dose 1.25‐ 10 mg per day q AM

– Starter Dose or with Breast Tenderness, 1.0 mg/d

– With Breast Cancer,1‐2 mg/d

– With Fatigue, 1-2.0 mg/d

— With Poor Libido 2.0 mg/d

Side effects of testosterone include acne, irritability, moodiness, anger, loss of hair or unwanted hair growth, irregular menses, decreased HDL, anxiety, depression, fatigue, hypoglycemia, salt and sugar cravings, insulin resistance and weight gain.  Systemic side effects are rare when administered topically.

Oxytocin-” The Love Hormone”

Oxytocin increases intimacy, the desire to be held and touched, reduces social anxiety, improves sexual function, libido, erection, and orgasm.

Oxytocin is deficient in estrogen deficiencies, hypothyroidism, especially low T3, depression, AIDS, CMV, multiple sclerosis, fibromyalgia, chronic stress, chronic opioid use, Parkinson’s Disease, loneliness, anxiety, fear, and certain types of schizophrenia.

Autistic patients exhibit high testosterone to low oxytocin ratio. Low Testosterone/High Oxytocin is seen in schizophrenia and bipolar depression.

Dose:

1. 25-800 IU (We usually start at 50 IU) as buccal troche or nasal spray
2. Compounded Combinations
   1. Daily Use:
      1. Oxytocin 50 IU
      2. Tadalafil 5 mg
      3. Apomorphine 2 mg

2. Vaginal Rejuvenation 

Platelet Rich Plasma

Remember when we were kids, fell and scraped our knee or elbow?  After the tears, Mom put mercurochrome or Absorbine, Jr on it, a Popeye the Sailor band-aid and told us to leave it alone.

Several days later a yellow “goo” formed around the scab. The “goo,” known as platelet-rich fibrin matrix, (PRFM), is the body’s way of healing itself. ⁽¹¹⁾ Eventually, new skin, containing all its’ components, collagen, fat, nerves and blood vessels grows to replace the scraped surface.

The key to the healing, the “goo,” consists of multipotent stem cells.  These are cells lying dormant, until called upon, to repair damaged tissue. Multipotent stem cells can only replace, not generate, tissue.

Omnipotent stem cells, the seeds of Frankenstein theoretically are capable of growing entire organisms. ⁽¹²⁾  Before continuing, to be clear, we are not dealing with anything even touching these ethical and political minefields. (Dolly, the famous “cloned” sheep, came about from adult stem cells, not embryonic as popularly thought.)⁽¹³⁾

Some stem cells regenerate tissue better than others.  Multipotent stem cells in your skin replaced the skin lost on your scraped elbow.  Brain tissue, when damaged, is poorly regenerated by neural multipotent stem cells.  Pancreatic stem cells are a bit more successful in restoring the pancreas, and liver stem cells regrow cirrhotic liver tissue.

The PRFM contains at least seven types of cell, blood vessel, collagen and tissue growth factors.  Through modern technology, through a simple blood draw and specialized centrifugation, we can harvest these stem cells to perform a fantastic array of rejuvenation activities. ⁽¹⁴⁾

⁽¹⁵⁾

Utilizing high end-FDA approved equipment ensures a good cell concentration.   By carefully separating the platelets from the red cells of the blood, we obtain the aforementioned growth factors.  If we were to include the red blood cells in our technique, it would cause unnecessary pain, inflammation, and bruising.

Once the platelets are isolated, we create the platelet-rich fibrin matrix.  By following the phenomena of the “goo,” how does the knee know it needs its stem cells, we see excess calcium levels in the wounded tissue as opposed to normal structures.  Calcium activates the chemical process, causing the platelets to form a clot, release growth factors, and turn the watery platelets into the yellow gel. ⁽¹⁶⁾

Adding a tiny amount of calcium to the platelet solution recreates the childhood scrape “goo.” If we inject the activated platelets after the calcium is added, but before it turns into the gel, we can remold the face, breast, and genital areas with fantastic results.

For women, vaginal lubrication and a ‘side effect,’ improvement of urinary incontinence, is an added bonus when it comes to sexual arousal and renewal.

PRP Technology via autologous injections injected into the Skene’s glands of the upper

vagina and clitoral head.⁽¹⁷⁾

Goals:   Stronger and More Frequent Orgasms

Increased Sexual Desire.

Improved Clitoral Stimulation.

Increased Natural Lubrication.

Increased Ability to Have a Vaginal Orgasm.

Decreased Urinary Incontinence.

Result:

Lasting improvement in sexual performance.

Rejuvenation of the vagina and clitoris.

A reawakening of orgasmic response.

 

Medical Conditions Treated With Vaginal PRP

1. Female Sexual Arousal Disorder
   1. Lack of Pleasure 5% incidence. Usually but not always accompanies Sexual Desire Disorder.
2. Hypoactive Sexual Desire Disorder (Low desire)-10% incidence
   1. Not counted a disorder unless it’s disrupting the woman’s life.
3. Female Orgasmic Disorder-5% Incidence
   1. Patient becomes aroused but has many difficulties with orgasm.
4. Dyspareunia-10-20% incidence
   1. Real pain with sex (not from decreased lubrication or vaginal spasm)
5. Lichen Sclerosis
   1. Patchy, white skin that appears thinner than normal affecting the genital and anal areas.
   2. Symptoms include redness, severe itching (pruritus), local discomfort or pain, smooth white or blotchy wrinkled skin patches, tearing or bleeding, blistering or ulcerated sores and painful sex
   3. Treatment includes: ⁽¹⁸⁾
      1. Topical B/L/T 20/8/8
      2. Intradermal or Subdermal PRP Injections on Day 1, 6 wks. later, then q 3-4 weeks as needed

Vaginal Rejuvenation-Protocol

Draw 60 cc Blood

▶ High-Speed Centrifuge (Double-Spin)

▶ BLT Laser Grade Anesthetic to Injection Site

▶ Spin 1-2 minutes-Draw off the plasma

▶ Spin 2-6 minutes Draw off Platelet Poor Plasma. Draw off top 20-23 ml.      Set Aside.

▶ Draw remaining Platelet Rich Plasma into Syringe

▶ Wait at least 15 minutes, inject Clitoral Head with 1-2 cc 2% Lidocaine

▶ Activate PRP with Calcium and Sodium Bicarb.

▶ Inject the Skene’s Glands In Upper Vagina 3-4 1 cc Boluses

▶ Inject 1-3 cc into Clitoral Head

PRP for Men

In men, PRP restores sexual performance, damaged by prostate enlargement, prostate cancer, and the after-effects of surgery.  PRP increases erectile firmness, blood flow and circulation, sexual stamina, prowess, sensation, pleasure, and improves urinary incontinence.

After applying topical and local anesthetics to the groin area, in sites of minimal innervation causing little to no discomfort, PRP is injected into areas of the penis responsible for the sexual response.

            Exosomes-The New Kid on the Block

            Malignant cells entering the blood or lymphatic systems and traveling to environmentally friendly organs, the liver, bone, and brain was the generally accepted theory of how cancer metastasized. In 2007 Swedish researcher Jan Lötvall, from the University of Gothenburg, changed that view with his discovery that tiny, 30-100nm in size, cells called “exosomes delivered DNA, RNA, and proteins to other cells, thereby altering the function genetic composition of the receiving cells.^(19-20)

We acupuncturists frequently joke that if we can do good with our needles, we can also flip to the “dark” side and do harm.   Similarly, in the world of exosomes, forward-thinking researchers deduced, correctly, that if these tiny pods of cellular instruction produce the destruction of metastatic cancer, they may be useful to restore health and vitality.  In other words,  perhaps we can hijack this molecular messenger system to do good rather than evil.  We could ferry drugs, and nutrients into cells in parts of the body especially hard to reach.

In 2012, researchers at Boston’s Children’s Hospital successfully treated lung damaged mice with exosomes derived from mesenchymal stem cells.  Human trials are underway in premature newborns, those with immature lung function. ⁽²¹⁾

Exosomes are the next generation of stem cells. Stem cells are immature cells able to make other blood cells that mature and function as needed.  Adult stem cells, generally, are derived from bone marrow while embryonic or mesenchymal stem cells come from the placenta.

The issue with stem cells is they may contain inflammatory proteins, called cytokines, the donor’s genetic material, and the donor’s blood type.  Any or all of these issues may cause the body to reject stem cells.

Exosomes are the progeny of stem cells.  Derived from the same base material, placental tissue, they are filtered of the above-mentioned inflammatory agents, blood type, and donor DNA. Regularly screened for hepatitis and HIV, exosomes are obtained from willing donors.

To date, exosomes most successful trials are in joint rehabilitation, ischemic and coronary artery disease, hypertension, peripheral vascular disease, stroke, and traumatic brain injury,  They target multiple cell types as “morph” into the properties of the donor cell.

Clinically exosomes are frequently combined with platelet-rich plasma, for facial rejuvenation, hair and joint restoration, vaginal atrophy and erectile dysfunction and intravenously for a global effect. ⁽²²⁾

Radiofrequency Energy and Laser Therapy

Radiofrequency delivers lasting improvements in sexual desire, vaginal sensitivity, intensity, intimacy, and ease of orgasm with a “side effect” profile similar to PRP, namely a 90% improvement in urinary continence. ⁽²³⁾

Heat, ranging from 39-47 Degrees Centigrade, applied to tissue improves microcirculation of the treated area, resulting in new collagen layers forming to strengthen, tighten, and thicken the underlying support structures.

Radiofrequency stimulates the nerves of the vaginal wall to release neuropeptides.  These neuropeptides signal the blood vessel walls to relax increasing circulation.  Increased circulation to the vaginal vault results in restored lubrication of the vaginal canal.  The clitoral area, including its head, arms, and saddlebags, containing approximately 8000 nerve endings, upregulates neuronal responsiveness to radio frequency applications.  This, in turn, upregulates nerve sensitivity to the area.

Radiofrequency is painless, requires no anesthetic, has no downtime, restores vaginal lubrication and comfort, and treats the entire vaginal vault along with the labia.  3 treatments 1 month apart are recommended followed by a PRP-Exosome injection.  Effects generally last one to two years.

As radiofrequency is not absorbed by melanin, radiofrequency is safe for all skin types .⁽²⁴⁾ A single-use S-shaped RF applicator, contoured for the vaginal vault and external genitalia delivers energy via a thermistor tip.⁽²⁵⁾

The ideal candidate for radiofrequency is one with vaginal laxity namely “loose skin,” vaginal dryness, Urinary Incontinence, a cystocele, and weak or non-existent orgasms.

Carbon Dioxide Laser System

CO₂  lasers treat internal vaginal tissue only and are not indicated for the labia or other external structures.  Both radiofrequency and CO ₂  lasers treat incontinence, vaginal dryness, and vaginal laxity.  Both are non-hormonal, stimulate the body’s natural collagen, are minimally or non-invasive and can be done in the office.

The difference is the energy source as a means to our desired end.  Radiofrequency generates heat; the CO₂ lasers punch micro holes into the vaginal wall.  Local and rarely general anesthesia may be necessary for patient comfort.⁽²⁶⁾  Side effects include redness, swelling, and discomfort and, on average, there is a downtime of 3 three days.  (Radiofrequency patients generally do not report any side effects and have zero downtime.)

A radiofrequency treatment instrument is a wand no more narrow than a finger. The CO₂ laser device is an inch in diameter.

A monthly, 3 treatment radiofrequency regimen with lasts, on average,  2-3 years.  A CO₂  laser treatment lasts 40-60 days.

Radiofrequency Versus CO₂ Laser

Radiofrequency	CO2  Laser
Radiofrequency	Fractional CO2  Laser
Heat Promotes Blood Flow and Collagen Stim	Heat and Ablation Increase Blood Flow
No Anesthesia	Local, Rarely General Anesthesia
No Downtime	Downtime: Up to 3 Days
30-minute appointment	30-minute appointment
3 Treatments Four weeks apart	3 treatments 6 weeks apart

 Treatment Zones Radiofrequency Versus CO₂ Laser

Radiofrequency

CO2 Laser

●        Atrophic Vulvovaginitis: Non-hormonal ●        Stress Incontinence ●        Labia Majora Laxity ●        Overactive Bladder ●        Vaginal Laxity ●        Pelvic Prolapse ●        Orgasmic Dysfunction: 50% average reduction time to achieve ●        Repetitive Vaginitis: Normalizes vaginal pH ●        Repetitive UTI: Normalizes vaginal tissues ●        Lichen Sclerosis and Hyperplastic Dystrophy: Adjunct to steroid and PRP

●        Atrophic Vulvovaginitis: Non-hormonal ●        Stress Incontinence ●        Repetitive Vaginitis ●        Repetitive UTI

 On balance, we believe the radio frequency device is a superior method for addressing the issues in our discussion with no downtime and no potential for damaging tissue as the laser can.

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