A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Peri-urethral and Clitoral Injections for the Treatment of Female Orgasmic Disorder

Female Orgasmic Disorder (FOD) is defined as a female sexual disorder with the presence of the following "on all or almost all (75%-100%) occasions of sexual activity":

1. Marked delay in, marked infrequency of, or absence of orgasm
2. Marked reduced intensity of orgasmic sensations.
3. The absence of orgasm must cause personal distress (bother) in order for these symptoms to be considered a disorder. (for example, women who are not very bothered by their lack of orgasm do not have FOD).

Symptoms must have been present for at least 6 months and are not better explained by a mental disorder or because of a relationship problems or other significant stress in the participant's life and not due to effects of substance abuse or new medications or other medical conditions.

Approximately one in twenty women have FOD and it is the second most frequently reported sexual problem in American women. FOD can either be lifelong (primary) or acquired (secondary).

There are no currently FDA approved treatments or devices for FOD. Therefore, common off-label treatments include psychotherapy/sex therapy, hormone therapy, and medications that increase blood flow to the genitals.

Platelet-rich plasma (PRP) is a platelet concentrate that may help to speed up tissue healing, without serious side effects, in some medical conditions. It has been tried as treatment for diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The only condition for which there are high-quality data and clear demonstration of effectiveness is arthritis of the knee. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects.

It has been suggested by many scientists that in some women FOD may be caused by decreased clitoral and genital blood flow secondary to blockage in the small blood vessels going to the clitoris (similar to that seen in erectile dysfunction (ED) in men) and/or diminished nerve conduction (also as seen in ED). PRP activates cells to develop into new tissue-nerves, collagen, and blood vessels. As such, PRP may potentially reverse the changes responsible for FOD. In addition, it has been shown that improved sexual function in women is highly linked with increased blood flow through the clitoris. One component of PRP is known to cause growth of new blood vessels. Therefore, the investigators anticipate PRP injections may potentially improve blood flow through both the clitoris and the tissue around the urethra, thereby improving sexual function and decreasing FOD.

In addition, it has been shown that women who easily achieve orgasm are more likely than women with FOD to have a larger clitoris and a clitoris positioned closer to the vaginal wall. Since PRP has been shown to increase connective tissue, injection of PRP into the clitoris may potentially enlarge the clitoris and may bring the clitoris closer to the vaginal wall, thereby improving orgasm.

There are some reports that physicians using the PRP as an injection near the urethra and clitoris have seen some patients with improvement in FOD after the injections. This is the first study that uses an objective comparative study to find out if this treatment works or not.