P-Shot® (Priapus Shot®) & P-100 Shot™
Informed Consent

Procedure Variants & Patient Selection

Navara Health offers two related sexual wellness procedures. Both are administered as injections into the same anatomic regions and use the same fundamental PRP technique. The P-100 Shot™ adds a small amount of intracavernosal botulinum toxin (Botox®) to the standard P-Shot® protocol.

I understand that my elected procedure may be modified at the time of treatment based on clinical assessment. Any change from my elected procedure will be discussed with me, and I may consent or decline before the change is made.

Acknowledgment & General Consent

I acknowledge that I have received information regarding my condition, the proposed P-Shot® or P-100 Shot™ procedure, alternative treatment options, and the potential risks and benefits associated with the procedure.

I understand that this consent form summarizes the information discussed and does not list every possible risk or outcome. I confirm that I have had the opportunity to ask questions and discuss concerns with Jessica Boggs, APRN, and that all of my questions have been answered to my satisfaction.

I understand that individual results vary and that no guarantee or assurance has been made regarding the outcome of this procedure. I voluntarily consent to the procedure I have selected and authorize the provider to perform any additional steps deemed medically necessary during the procedure if delay could impair my health or safety.

Description of Procedure

The P-Shot® and P-100 Shot™ procedures involve the use of Platelet-Rich Plasma (PRP) derived from my own blood. PRP contains concentrated platelets and growth factors that are intended to support tissue function and regeneration. The P-100 Shot™ additionally uses intracavernosal botulinum toxin type A (Botox®).

Stated and reported goals of these procedures may include improvement in:

• Erectile function and rigidity
• Sexual sensation and performance
• Response to oral ED medications (PDE5 inhibitors such as sildenafil, tadalafil)
• Penile tissue health and integrity
• Symptoms associated with Peyronie's disease (off-label, adjunct, case-by-case)
• Outcomes following prostatectomy or radiation (off-label, case-by-case)
• Mild penile shape concerns related to vascular function

Outcomes are variable and not guaranteed. Exosomes are NOT used at Navara Health.

FDA & Off-Label Use Disclosure

I understand and acknowledge that:

• The use of PRP for sexual enhancement, erectile function, penile rejuvenation, and Peyronie's disease is considered off-label
• The use of intracavernosal botulinum toxin (Botox®) for erectile function is also off-label. Botox® is FDA-approved for various medical and cosmetic indications, but not for intracavernosal injection or erectile dysfunction.
• These procedures are not FDA-approved for the indications discussed
• PRP is generated from my own blood; the FDA generally does not regulate autologous PRP as a drug, but the specific clinical applications remain off-label
• No claims or guarantees of effectiveness are made
• Off-label use of legally available techniques and medications is permitted in medical practice at the provider's clinical discretion
• I am voluntarily electing this therapy with full awareness of its off-label status
• The CMA P-Shot® protocol is a trademarked clinical procedure developed by Charles Runels, MD

Chaperone, Dignity & Procedure Environment

Regardless of chaperone selection, Navara Health is committed to:

• A private, dignified procedure environment with appropriate draping and minimized exposure
• Professional communication throughout the procedure
• Your right to pause or stop the procedure at any time
• Privacy from interruption during the procedure

Pre-Procedure Preparation & Disclosures

Medical History & Reproductive Considerations

I understand and acknowledge:

• I will disclose any history of Peyronie's disease, penile fibrosis, penile fracture, prior penile surgery, prior radiation, prior implants, or vascular abnormalities. These conditions may affect candidacy, technique, or expected outcomes.
• I will disclose any history of cardiovascular disease, anticoagulation therapy, bleeding disorders, hypertension, diabetes, or other chronic conditions. Some conditions may require coordination with my primary care or cardiology provider before proceeding.
• I will disclose current medications and supplements, including PDE5 inhibitors and any blood-thinning agents.
• If I am of reproductive potential and wish to preserve fertility, I understand that this procedure is not expected to affect fertility, but long-term data is limited. I have discussed any fertility concerns with my provider.
• If my partner is pregnant or attempting pregnancy, this does not preclude the procedure, but I will avoid sexual activity per the post-procedure restrictions.

Psychological & Relationship Considerations

Risks & Possible Complications

P-100 Shot™ — Additional Botox®-Specific Disclosures

Priapism — Specific Risk Disclosure

Neurologic & Anesthetic Risks

Neurologic Risks

• Nerve injury
• Temporary or permanent numbness
• Hypersensitivity of treated areas
• Fatigue, dizziness
• Embolism (extremely rare)

Anesthetic Risks

• Allergic reactions to lidocaine or topical anesthetics
• Lidocaine toxicity — perioral numbness, ringing in ears, dizziness, seizures, cardiac effects (rare with proper dosing)
• Anaphylaxis (rare)
• I consent to administration of local anesthetic agents (topical lidocaine, injectable lidocaine, penile nerve block, or other agents as deemed necessary by the provider)

I understand that medicine is not an exact science and that additional known or unknown risks may occur.

Alternatives to Treatment

I understand that alternatives include, but are not limited to:

• No treatment — observation without intervention
• Oral PDE5 inhibitors — sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), avanafil (Stendra)
• Hormone optimization — testosterone replacement therapy if indicated based on lab evaluation
• Vacuum erection devices
• Intracavernosal injection therapy — alprostadil (Caverject), Trimix
• Intraurethral suppositories — alprostadil (MUSE)
• Penile implants or surgical interventions — performed by urology when indicated
• Low-intensity shockwave therapy (Li-ESWT)
• Sex therapy or couples counseling
• Referral to specialty care — urology, sexual medicine specialist, mental health

I understand that I may decline this procedure at any time, before, during, or after consent.

Photography & Marketing — Special Restrictions

Post-Procedure Care

To support healing and reduce risk of complications, I will follow these post-procedure care instructions:

• Sexual abstinence for 48-72 hours after the procedure
• Light activity for the first 24-48 hours; avoid strenuous exercise, heavy lifting, hot baths, swimming, and saunas for 24-48 hours
• Showers are fine; gentle cleansing of the external area only
• Loose, comfortable underwear for the first 24-48 hours
• Mild bruising or discoloration may appear and resolves over 7-10 days
• Discomfort or mild swelling may be managed with ice packs (10-15 minutes on, applied externally with a barrier) and acetaminophen (avoid aspirin or NSAIDs for 24-48 hours, which may impair PRP function)
• Hydrate well after the procedure
• Expected timeline: initial effects may be noticed within 2-3 weeks; full effect typically at 8-12 weeks
• Some patients benefit from a second treatment at 8-12 weeks
• For P-100 Shot™ recipients: Botox® effect typically begins within 7-14 days and lasts 3-4 months
• Watch for and report: fever, severe pain not relieved by acetaminophen, heavy bleeding, signs of infection (expanding redness, warmth, pus, fever, chills, red streaks), signs of allergic reaction, generalized muscle weakness or difficulty swallowing/breathing/vision changes (P-100 only — emergency), erection lasting more than 4 hours — go to ER immediately

Financial Acknowledgment

• The P-Shot® and P-100 Shot™ procedures are not covered by insurance
• Payment is due at the time of service
• The P-100 Shot™ is priced higher than the P-Shot® due to the addition of Botox® and additional procedural time
• No refunds are available once the procedure has been performed
• If a second treatment is recommended, it will be priced separately
• Treatment of complications, if needed, may incur additional cost

Contraindications & Cautions

The P-Shot® or P-100 Shot™ may be contraindicated, deferred, or require modification if I have or disclose:

• Active penile, urinary tract, or systemic infection
• Active herpes simplex outbreak in the procedure area (defer until healed)
• Active sexually transmitted infection
• Bleeding disorder or active anticoagulant therapy without provider coordination
• Active genitourinary cancer or recent oncology treatment
• Active autoimmune disease in flare (case-by-case)
• Sickle cell disease or trait (priapism risk)
• Leukemia or other clotting disorders (priapism risk)
• Use of medications associated with priapism (case-by-case)
• Penile implants (case-by-case based on implant type)
• Severe penile fibrosis or extensive Peyronie's disease (case-by-case)
• Active mental health crisis or untreated severe psychological distress
• Inability to lie still and remain comfortable during the procedure
• Severe needle phobia preventing safe procedure completion
• Unrealistic expectations
• Inability to follow post-procedure care instructions
• For P-100 Shot™ additionally: known allergy to botulinum toxin, neuromuscular disorders (myasthenia gravis, Lambert-Eaton, ALS), aminoglycoside antibiotic use

Communication & HIPAA Authorization

I authorize Navara Health to communicate with me regarding scheduling, treatment, follow-up, and adverse event reporting through:

• The secure HIPAA-compliant patient portal
• Email to the address I have provided
• SMS / text message to the mobile number I have provided
• Telephone calls to the number I have provided

I understand that email and SMS are not fully secure channels. I may revoke authorization for any specific channel in writing to contact@navarahealthtx.com. Given the sensitive nature of this procedure, I may request enhanced confidentiality measures, including limiting communications to the patient portal only.

Assumption of Risk & Release of Liability

I voluntarily assume all known, unknown, and unforeseen risks associated with the P-Shot® or P-100 Shot™ procedure. To the fullest extent permitted by law, I agree to release, indemnify, and hold harmless Navara Health, PLLC, Jessica Boggs APRN, the medical director, and all affiliated providers, nurses, staff, contractors, and agents from liability related to:

• Procedural complications, including infection, bleeding, scarring, nodule formation, fibrosis, nerve injury
• Sexual function changes, including dyspareunia or worsened erectile function
• Priapism and any sequelae
• Botox®-related effects (for P-100 Shot™ recipients), including local diffusion or systemic effects
• Lack of expected results or treatment failure
• Allergic or anesthetic reactions
• Psychological, emotional, or relational effects
• Effects related to undisclosed medical history, medications, or supplements
• Outcomes related to failure to follow pre- or post-procedure care
• Long-term or delayed effects not yet known

This release does not apply to cases of gross negligence or willful misconduct, and does not waive any right that cannot lawfully be waived under the laws of the State of Texas.

Dispute Resolution & Governing Law

Any dispute, controversy, or claim arising out of or relating to this Consent or the P-Shot® or P-100 Shot™ procedure shall first be addressed by good-faith negotiation. If not resolved within thirty (30) days, the parties agree to submit the dispute to binding arbitration in Dallas County, Texas, under the rules of a recognized arbitration body. The parties waive the right to a jury trial.

This Consent shall be governed by the laws of the State of Texas. If any provision is found unenforceable, the remaining provisions shall remain in full force and effect.