Clitoxin Consent Form

Informed Consent for the Clitoxin™ Procedure

 The purpose of this informed consent form is to provide written information regarding the risks, benefits, and alternatives of the Clitoxin™ procedure. All medical and cosmetic procedures carry risks and may cause complications. The purpose of this document is to inform you of the nature of the procedure and its risks in advance so that you can decide whether to proceed with the procedure. This information serves as a supplement to the discussion you have with your doctor/healthcare provider. You must fully understand this information, so please read this document thoroughly. Ask your doctor/healthcare professional before signing the consent form if you have any questions regarding the procedure.

THE TREATMENT

Botulinum Toxin A (BoNT) is a neurotoxin produced by the bacterium Clostridium A. Botulinum Toxin A is diluted to a very controlled solution and is then injected into the clitoris to improve sexual function.

I understand that the use of Botulinum Toxin A (BoNT) in this procedure is an “off-label” use, and no promise or representation, guarantee or warranty regarding its use, benefit or other quality is made. No representations that the use of this product and this procedure is approved by Health Canada or any other agency of the federal or provincial government is made. I understand there are alternative treatments to improve sexual function in women and alternatives also include the option of no treatment at all.

RISKS AND COMPLICATIONS

Before undergoing this procedure, understanding the risks is essential. No procedure is completely risk-free. The following risks may occur, but there may be unforeseen risks that are not included on this list.  Some of these risks, if they occur, may necessitate hospitalization and/or extended outpatient therapy to permit adequate treatment. It has been explained to me that there are certain inherent and potential risks and side effects in any invasive procedure, and in this specific instance, such risks include but are not limited to the following:

Bleeding

Infections

Urinary retention

No effect at all

Allergic reactions

Constant awareness of the G-Spot

A sensation of always being sexually aroused

Constant vaginal wetness

Mental preoccupation of the G-Spot

Alteration of the function of the G-Spot

Sexual function alteration

Hematoma

Urethral injury (tube you urinate through)

Urinary retention

Hematuria (blood in urine)

UTI (Urinary Tract Infection)

Urinary Urgency (feel like you always have to urinate)

Urinary Frequency

Increased/worsening nocturia (waking up several times at night to urinate)

Change in urinary stream

Urethral vaginal fistula (hole between urethra and vagina)

Vesico-vaginal fistula (hole between bladder and vagina)

Dyspareunia (Painful intercourse)

Need for subsequent surgery

Alteration of vaginal sensations

Scar formation (vaginal)

Urethral stricture (abnormal narrowing of the urethra)

Local tissue infarction and necrosis

Yeast infections

Vaginal Discharges

Spotting between periods

Bladder Pains

Overactive Bladder (OAB)

Bladder Fullness

Exposed Material

Pelvic Pains

Pelvic Heaviness

Erosions

Fatigue

Damage to nearby organs including bladder, urethra and ureters

Alteration of bladder dynamics

Post-operative pain

Prolonged pain

Intractable pain

Alteration of the female sexual response cycle

Failed procedure

Varied results

Psychological alterations

Relationship problems

Sex life alteration

Decreased sexual function

Possible hospitalization for treatment of complications

Lidocaine toxicity

Anesthesia reaction

Embolism

Depression

Reactions to medications including anaphylaxis

Nerve damage

Permanent numbness

Slow healing

Swelling

Sexual dysfunction

Allergy

Nodule formation

Post treatment discomfort, swelling, redness, and bruising;

Post treatment bacterial, and/or fungal infection requiring further treatment;

Allergic reaction: hives, itching; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat;

Transient headache;

Flu-like symptoms, fever, chills, body aches;

Unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

Loss of bladder control;

Hoarse voice, trouble talking or swallowing;

Drooping eyelids or eyebrows;

Vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light);

Chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats;

Pain or burning when you urinate, trouble emptying your bladder;

Sore throat, cough, chest tightness, shortness of breath;

Eyelid swelling, crusting or drainage from your eyes, problems with vision;

Painful or difficult urination;

Headache, neck pain, back pain, pain in your arms or legs;

Cold symptoms such as stuffy nose, sneezing, sore throat;

Increased sweating in areas other than the underarms; and

Bruising, bleeding, pain, redness, or swelling where the injection was given.

ALLERGIES, NEUROLOGIC DISEASE & TOXIN INGREDIENTS

-I do not have any significant neurologic disease including but not limited to the following:

myasthenia gravis;

multiple sclerosus;

lambert-eaton syndrome;

amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease"); or,

Parkinson’s disease.

-I have not had any of the following:

Botulinum Toxin A injections of over 100 units in the last 4 months;

side effects after prior use of Botulinum Toxin A;

breathing disorder such as asthma or emphysema;

problems with swallowing;

facial muscle weakness (droopy eyelids, weak forehead,

trouble raising my eyebrows);

change in the normal appearance of my face;

bleeding problems.

-I understand that botulinum toxin is produced by the bacterium Clostridium A. I do not have any allergies to Botulinum Toxin A (BoNT)

ALTERNATIVE PROCEDURES

Alternatives and options to the procedure have been fully explained to me.

PAYMENT

I understand that this is an "elective” procedure, and that payment is my responsibility and is expected at the time of treatment.

RIGHT TO DISCONTINUE TREATMENT

I understand that I have the right to discontinue treatment at any time.

CONSENT FOR ANESTHESIA

When the physician uses local anesthesia and/or sedation:

I consent to the administration of such local anesthetics as may be considered necessary by the physician in charge of my care. I understand that the risks of local anesthesia include the following: local discomfort, swelling, bruising, allergic reactions to medications, and seizures from lidocaine.

ELECTIVE PROCEDURE

I understand Clitoxin™ is an elective procedure, and I hereby voluntarily consent to treatment with Botulinum Toxin A (BoNT) injections into the clitoris to improve sexual function. The procedure has been fully explained to me. I also understand that any treatment performed is between me and the doctor/healthcare provider who is treating me, and I will direct all post-operative questions or concerns to the treating clinician. I have read the above and understand it. My questions have been answered satisfactorily. I accept the risks and complications of the procedure and understand that no guarantees are implied as to the procedure's outcome. I also certify that if I have any changes in my medical history, I will notify the doctor/healthcare professional who treated me immediately. I also state that I read and write in English.

I am the treating doctor/healthcare professional.  I discussed the above risks, benefits, and alternatives with the patient. The patient had an opportunity to have all questions answered and was offered a copy of this informed consent.  The patient has been told to contact my office should they have any questions or concerns after this treatment procedure.