O-Shot® (Orgasm Shot®)
Informed Consent

Acknowledgment & General Consent

I acknowledge that I have received information regarding my condition, the proposed O-Shot® / Orgasm Shot® procedure, alternative treatment options, and the potential risks and benefits associated with this 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 O-Shot® / Orgasm Shot® procedure 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 O-Shot® / Orgasm Shot® procedure involves 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 goal of this procedure may include improvement in:

• Sexual sensation, arousal, and lubrication
• Orgasmic response
• Urinary symptoms (mild stress urinary incontinence, urgency)
• Vaginal tissue health and integrity
• Symptoms associated with lichen sclerosus (off-label, case-by-case)

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, vaginal rejuvenation, and urinary symptom improvement is considered off-label
• This procedure is not FDA-approved for these indications
• 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 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 O-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

Pregnancy, Breastfeeding & Reproductive Considerations

I understand and acknowledge:

• The O-Shot® procedure is not recommended during pregnancy or breastfeeding due to limited safety data and hormonal influences on tissue response
• I confirm I am not currently pregnant. If I am of reproductive potential and not using effective contraception, pregnancy testing may be performed
• If I am breastfeeding, I understand the procedure is typically deferred until at least 3 months after weaning
• I will notify Navara Health immediately if I become pregnant before the procedure
• Postpartum considerations: the procedure is typically deferred at least 6 weeks (vaginal delivery) to 12 weeks (cesarean) postpartum, longer if breastfeeding
• Hormonal fluctuations (menopause, perimenopause, oral contraceptive use, hormone therapy) may affect tissue response; concurrent BHRT can be coordinated with my provider

Psychological & Relationship Considerations

Risks & Possible Complications

Persistent Genital Arousal Disorder (PGAD)

Neurologic & Anesthetic Risks

Neurologic Risks

• Nerve injury
• Temporary or permanent numbness
• Fatigue
• Dizziness
• Embolism (extremely rare)
• Seizures (extremely rare, typically anesthetic-related)

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, 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
• Pelvic floor physical therapy — for urinary symptoms, dyspareunia, and pelvic muscle dysfunction
• Hormonal therapy — vaginal estrogen, systemic BHRT, DHEA suppositories, testosterone (for HSDD when appropriate)
• Non-hormonal medications — flibanserin (Addyi) or bremelanotide (Vyleesi) for HSDD; ospemifene for GSM
• Sex therapy or couples counseling
• CO2 laser or radiofrequency vaginal therapy — alternative energy-based vaginal rejuvenation
• Surgical interventions — performed by gynecology or urogynecology when indicated
• Referral to specialty care — gynecology, urogynecology, sexual medicine specialist, pelvic floor therapy, 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 72 hours after the procedure
• Avoid tampons, douching, internal medications, or internal devices for 72 hours
• 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
• Mild spotting may occur for 1-2 days and is normal
• Discomfort or mild swelling may be managed with ice packs (10-15 minutes on, applied externally) 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 3 weeks; full effect typically at 8-12 weeks
• Some patients benefit from a second treatment at 12 weeks
• Watch for and report: fever, severe pain not relieved by acetaminophen, heavy bleeding, signs of UTI (burning urination, frequency), foul-smelling discharge, signs of allergic reaction, persistent unwanted arousal sensations

Financial Acknowledgment

• The O-Shot® procedure is not covered by insurance
• Payment is due at the time of service
• 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 O-Shot® may be contraindicated, deferred, or require modification if I have or disclose:

• Active vaginal, vulvar, urinary tract, or systemic infection
• Active herpes simplex outbreak in the procedure area (defer until healed)
• Pregnancy, possible pregnancy, immediate postpartum, or active breastfeeding
• Active menstruation
• Bleeding disorder or active anticoagulant therapy without provider coordination
• Active gynecologic cancer or recent gynecologic oncology treatment
• Active autoimmune disease in flare (case-by-case)
• Severe atrophic changes that may require alternative or additional treatment
• Active sexual trauma or untreated severe psychological distress related to gynecologic procedures
• 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

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 O-Shot® / Orgasm 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, nerve injury
• Urinary, pelvic, or sexual function changes, including dyspareunia or PGAD
• Lack of expected results or treatment failure
• Allergic or anesthetic reactions
• Psychological, emotional, or relational effects
• Effects related to undisclosed medical history, medications, supplements, or reproductive status
• 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 O-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.