Sexual Wellness Treatment with Exosomes or Stem Cells

1. Patient Selection Criteria

Ideal Candidates:

• Men: Mild to moderate erectile dysfunction (ED), decreased sensitivity, or seeking improvement in overall sexual performance.
• Women: Symptoms of vaginal atrophy, decreased sensitivity, reduced lubrication, or those seeking to enhance sexual comfort and function.

Considerations:

• Patients should be in generally good health, with no active infections or contraindicated conditions.

Contraindications:

• Infections or Inflammation: Any active infection in the pelvic area, including STIs or local skin infections, must be resolved prior to treatment.
• Allergic Reactions: A history of severe allergies to injectables, exosome products, or anesthetics should be assessed.
• Pregnancy and Breastfeeding: Contraindicated due to unknown effects on fetal or infant development.
• Chronic Conditions: Patients with uncontrolled diabetes, blood clotting disorders, or severe autoimmune diseases should be carefully evaluated or excluded.

2. Preparation

Clinic Preparation:

• Sterile Environment: Ensure the treatment room is set up with sterile instruments and surfaces to prevent any contamination.
• Required Equipment:
• Exosome product vial (check expiration date and manufacturer guidelines for storage and handling).
• 3 mL syringes with 27–31 gauge needles for fine, precise injections.
• Topical antiseptic solution (e.g., chlorhexidine or alcohol) for skin preparation.
• Local anesthetic (e.g., lidocaine cream or injection) for patient comfort if desired.

Patient Preparation:

• Informed Consent: Explain the treatment thoroughly, including goals, potential benefits, risks, and expected results. Address any questions the patient may have.
• Anesthetic Discussion: Offer a local anesthetic for comfort. If used, allow time for the anesthetic to take effect (typically 5–15 minutes for topical cream, 2–5 minutes for injectable).
• Skin Preparation: Cleanse the treatment area thoroughly with antiseptic to reduce the risk of infection. For male patients, clean the penile shaft; for female patients, cleanse the vaginal entrance and surrounding area.
• Patient Preparation: It is generally recommended 24 hours prior to treatment for both male and female patients to trim the pubic hair from their pubic regions for easier administration.

3. Dosage and Administration

• Product: Sexual Wellness Exosomes
• Administration Method:Injection, performed by trained medical personnel in a clinical setting.

For Male Patients

Anesthetic Application (Optional):

• Topical Anesthetic: Apply lidocaine cream along the penile shaft, focusing on the areas to be injected. Wait 5–10 minutes for the anesthetic to take effect.
• Injectable Anesthetic: Inject a small amount of lidocaine into the base of the penile shaft if a stronger effect is preferred. Wait 2–5 minutes for numbing.

Injection Preparation:

• Draw 2 mL of sterile saline into a sterile syringe.
• Draw 1–2 mL of the exosome solution into the sterile syringe.
• There are 2 main methods for Penile Injections for these treatments:
• Two Injections Total: One on each side at the base of the penis into the corpus cavernosum (approximately 10 & 2 positions of the shaft).
• Four Injections Total: Two on each side. Two at the base of the penis into the corpus cavernosum (approximately 10 & 2 positions of the shaft) and two further up from the base, approximately ½ inch from the first two injections.
• Five Injections Total: Two on each side and one into the penile head. Two at the base of the penis into the corpus cavernosum (approximately 10 & 2 positions of the shaft), two further up from the base approximately ½ inch from the first two injections, and one into the beginning of the glans or head of the penis.
• Prepare injection points along each side of the penile shaft and head (if doing the glans injection). These points should be identified and marked along the corpus cavernosum to ensure accurate placement.
• Note: Many practitioners report that the two-injection method is as effective as the five-injection method due to the continuity of the penile tissues. A medical director can determine the method to use.

Injection Technique:

• Using a 27–30 gauge needle, insert the needle into the marked area along the corpus cavernosum at a 90-degree angle (10 & 2 position).
• Slowly inject half of the solution into each side, delivering the exosomes evenly along the shaft.
• Apply gentle pressure to each injection site with sterile gauze to prevent bleeding and ensure proper distribution.

Post-Injection Care:

• Check for any immediate swelling or bruising and reassure the patient that mild discomfort is normal and should subside.
• Instruct the male patient to apply pressure at the base of the penis through the glans to help the solution completely fill the penile tissue.
• Advise the patient to avoid sexual activity, vigorous exercise, and alcohol for 24–48 hours post-treatment.

For Female Patients

Anesthetic Application (Optional):

• Topical Anesthetic: Apply lidocaine cream to the vaginal opening, particularly the entrance and the G-spot area if known. Wait 5–15 minutes for effect.
• Injectable Anesthetic: Administer a small amount of lidocaine to the vaginal wall if additional numbing is desired. Wait 2–5 minutes.

Injection Preparation:

• Draw 2 mL of sterile saline into a sterile syringe.
• Draw 1–2 mL of the exosome solution into the sterile syringe (the syringe will have 3–4 mL of solution).
• Identify three main injection points:
• Clitoris and clitoral hood
• Labia minora: Above the vaginal opening.
• G-spot region: Typically 1–1.5 inches inside the top vaginal wall.

Injection Technique:

• With the patient in a comfortable position (e.g., laying down with legs apart or reclining with knees bent), carefully insert the needle at the identified injection points.
• Inject 1/3 of the exosome solution at each point, using a slow and steady injection technique to ensure even distribution and patient comfort.
• Gently apply sterile gauze to any injection site as slight bleeding may occur.

Post-Injection Care:

• Advise the patient that mild soreness or swelling may occur but should subside within a day.
• Instruct them to avoid sexual activity, douching, or use of tampons for 24–48 hours.

4. Post-Treatment Care

Immediate Post-Treatment Instructions:

• Advise the patient to avoid vigorous activities, including exercise and sexual intercourse, for at least 24–48 hours to allow the exosomes to integrate with the tissue effectively.
• Let the patient know that some mild discomfort, bruising, or swelling may occur around the injection sites and should resolve naturally.

Managing Side Effects:

• Mild pain relievers (e.g., acetaminophen) may be used if needed, but NSAIDs should be avoided as they may interfere with the inflammatory phase of healing.
• Instruct the patient to contact the clinic if they experience severe pain, significant swelling, or signs of infection (e.g., redness, warmth, fever).

5. Safety Precautions

Immediate Monitoring:

• Observe the patient for 10–15 minutes after the procedure to ensure no adverse reactions, particularly allergic reactions.

Emergency Preparedness:

• Keep epinephrine and antihistamines on hand in case of any unexpected allergic response.
• Ensure that the clinical team is prepared to respond to emergencies, although such reactions are rare with exosome therapy.

Infection Prevention:

• Use strict aseptic techniques throughout the procedure to minimize the risk of infection.

6. Follow-Up and Monitoring

First Follow-Up:

• Schedule a follow-up appointment 2–4 weeks after the initial treatment to assess the patient’s response, discuss any observed changes, and answer questions.
• Review any side effects or concerns with the patient to determine if additional care is needed.

Additional Sessions:

• For optimal results, a series of 1–3 sessions may be recommended, spaced approximately 4–6 weeks apart.
• Adjust treatment frequency and dosing based on patient response and clinical observations.

Long-Term Monitoring:

• Encourage regular check-ins to monitor the patient’s progress over several months, especially if they’re undergoing multiple treatments.
• Educate the patient on maintaining wellness practices (e.g., healthy lifestyle, regular exercise) to support treatment outcomes.

7. Documentation

Procedure Notes:

• Record all relevant details in the patient’s medical record, including:
• Type and dosage of exosome product used.
• Injection locations and techniques used.
• Patient response during the procedure.
• Document any post-treatment observations or instructions provided to the patient.

Outcome Tracking:

• Include notes on patient feedback during follow-up appointments to monitor the treatment’s effectiveness over time.
• Track any need for adjustment in dosing or frequency in the patient’s file.

Summary

This protocol offers a structured, detailed approach to delivering sexual wellness treatments with exosomes. By following these steps, clinics can ensure consistent and effective treatments, enhancing patient experience and clinical outcomes. This detailed guide supports clinic staff in administering treatments confidently and addresses each aspect of care to minimize potential risks and maximize patient satisfaction.