A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Peri-urethral and Clitoral Injections for the Treatment of Female Orgasmic Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 25 - 50 |
| Updated: | 6/17/2017 |
| Start Date: | June 28, 2017 |
| End Date: | July 2019 |
| Contact: | Andrew T Goldstein, MD |
| Email: | obstetrics@yahoo.com |
| Phone: | (202) 887-0568 |
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 your
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, we 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.
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 your
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, we 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.
Inclusion Criteria:
〈 Female, 25-50 years old. 〈 Premenopausal 〈 Signed written informed consent. 〈
Willingness and ability to comply with the study requirements. 〈 Subject must meet all of
the criteria of FOD as listed in the DSM 5 〈 Subjects must score between 0-4 on the Orgasm
Domain of the FSFI 〈 Previously had satisfying orgasms 〈 Score 11 or greater on the Female
Sexual Distress Scale - revised (FSDS-R) 〈 Are in a continuous, stable sexual relationship
with the same partner for at least the 12 months immediately before study enrollment
Exclusion Criteria:
〈 Who are menopausal 〈 Who have primary FOD 〈 Who have pain during sex 〈 Who are
immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled
malignant disease.
〈 Who are not in a stable sexual relationship of at least 12 month duration 〈 Who suffer
from systemic or generalized infections (bacterial, viral or fungal).
〈 Taking psychotropic medications including SSRIs, SNRIs, TCA, bupropion, mood
stabilizers, & treatments for ADD or ADHD including Adderall and similar compounds.
〈 Taking sildenafil, vardenafil, tadalafil 〈 Taking topical or systemic estrogen or
testosterone 〈 Taking oral contraceptive pills 〈 Who have been diagnosed with lichen
sclerosus, lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma
of the vulva.
〈 Who had received an investigational drug within four weeks prior to the study or who
intend to use other investigational drugs during the course of this study.
〈 Patients with severe medical condition(s) that in the view of the investigator prohibits
participation in the study.
〈 Who have a history of substance abuse or any factor, which limits the subject's ability
to cooperate with the study procedures.
Who are uncooperative, known to miss appointments (according to subjects' records) and are
unlikely to follow medical instructions or are not willing to attend regularly scheduled
visits.
We found this trial at
1
site
3 Washington Circle Northwest
Washington, D.C., District of Columbia 20037
Washington, D.C., District of Columbia 20037
Phone: 202-887-0568
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