madman
Super Moderator
Historical Overview of Sexual Dysfunction Treatments
• Treatments for sexual dysfunction have existed for millennia, often based on superstition, ritual, or unproven remedies.
• Ancient Egypt:
◦ "Tale of King Huni and the Magician"—incantation ceremony to restore youth, involving animal heads; planned trial on a prisoner, not completed.
◦ Obsession with youth restoration dates back thousands of years.
• Ancient Greece and Rome:
◦ Use of "satyrin" as an aphrodisiac—possibly ragwort or an orchid with testicle-like roots; theory of consuming plant roots to enhance sexual function.
◦ Satyrin orchid now extinct; similar plants (e.g., salep) used in drinks like Turkish hot milk, but no proven aphrodisiac effect.
• Medieval Europe:
◦ "Love bread": naked maidens frolic counterclockwise in wheat fields; wheat used to bake bread believed to restore male vitality.
◦ Use of camel hump fat, ass’s milk, ginger, and cloves as topical treatments; "figging" (application of ginger to genitals/anus) as sexual enhancement.
• 20th Century:
◦ Dr. Jonathan Romulus Brinkley (Kansas, 1920s–30s): "Goat gland transplant"—implanting goat testicle tissue into men for various ailments (impotence, infertility, etc.); became wealthy, ran for governor, had a radio show; some patients died due to infection; therapy now discredited.
◦ Dr. Nikolai Borgeras (1930s–40s): Ridge cartilage interposition surgery—used abdominal tube grafts and rib cartilage to create semi-rigid neophallus for penile reconstruction; precursor to modern reconstructive techniques.
Modern Standard Treatments for Erectile Dysfunction
• "Big Four" current options:
◦ PDE5 inhibitors
◦ Vacuum erection pump (with/without constriction ring)
◦ Medicated urethral system for erections (Muse, now also in gel form)
◦ Intracavernosal injections (only one FDA-approved ingredient; others used off-label)
◦ Penile prosthesis
• Historical note:
◦ Dr. Giles Brindley (AUA, 1983): Discovered intracavernosal injection efficacy after self-experimentation with phenoxybenzamine; demonstrated at AUA meeting; pivotal moment in ED therapy history.
FDA and Medical Device Classifications
• FDA roles:
◦ Approves drugs, biologics, and equipment for safety and efficacy.
◦ Regulates medical devices, cosmetics, food safety, tobacco, public information, counterterrorism, and emergency response.
◦ Emergency Use Authorization (e.g., COVID vaccines).
• Device classes:
◦ Class 1: Low risk, basic items (wound dressings, gloves, vibrators, reading glasses); expedited approval, often sold before approval.
◦ Class 2: Moderate risk (medical imaging, glucometers, IV pumps, power wheelchairs, some soundwave devices); require more regulation.
◦ Class 3: High risk, implanted devices (penile implants, lithotripters); require rigorous testing and approval.
• FDA approval:
◦ Indicates rigorous review for safety/effectiveness, but not a permanent guarantee.
• Dietary Supplement Act of 1994:
◦ Allows manufacturers to make structural/function claims (e.g., "supports bone health") but not disease treatment/cure claims; disclaimer required on labels.
Evaluation of Alternative and Emerging Therapies
• Acoustic Wave Therapy (Shockwave):
◦ Types: Focused shockwave (narrow, high energy, deep penetration) vs. radial shockwave (spreads out, less penetration).
◦ Low-intensity and high-intensity variants; most approved for musculoskeletal use, not ED.
◦ Many clinics use off-label for ED, piggybacking on old musculoskeletal approvals.
◦ GainsWave: Claims to stimulate new blood vessels, break down microplaques, increase blood flow, and cure Peyronie’s; lacks validation from robust studies.
◦ Heavy celebrity endorsement and advertising (e.g., Dennis Rodman); maintenance therapy often required, raising concerns about efficacy and financial motivation.
◦ At-home devices (e.g., Phoenix) widely marketed; often not used by urology-trained providers.
◦ Caution advised due to lack of evidence, regulatory loopholes, and aggressive marketing.
Stephen Carlson
Summary
Mohit Khera
Conclusion
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