Platelet-rich plasma is a substance derived from the participants' own blood and is not
considered a drug. It is created through centrifugation of a participant's whole blood to
separate out red blood cells leaving a concentrated plasma product containing the
participant's natural endogenous growth factors and cytokines. PRP has been studied and
found to be effective and safe without serious side effects in specialties such as
orthopedics and dermatology. It is unclear if PRP injections to the anterior vaginal wall
and clitoris improves sexual function and stress urinary incontinence. To date, the only
literature on this is a single arm unblinded study.
This will be a single-blinded randomized controlled trial. Our primary objective is to
determine if platelet rich plasma (PRP) injections into the anterior vaginal wall and
periclitoral tissues boosts sexual satisfaction in sexually active women without a
history of female sexual dysfunction (FSD). Our secondary objective is to determine the
effect of PRP injections on sexual function. Qualifying subjects will be randomized 1:1
in permutated blocks to receive either PRP injection or placebo control (sterile saline
injection). They will be followed for 6 month in the following fashion:
Visit #1: Screening, Baseline & Enrollment (virtual visit) This visit will be done
virtually. Premenopausal sexually-active women meeting the listed inclusion criteria and
exclusion criteria will view a short powerpoint orienting them to the research study and
offer background about PRP and its proposed benefit for sexual function. Afterwards, a
research team member will review the study and informed consent form, answer any
questions, and, if they are interested in participating, the coordinator will obtain
verbal informed consent and document verbal consent, and enroll the subject. The subject
will then be asked to complete a series of questionnaires.
Visit #2: Randomization & Intervention (in-person visit) Subjects attending the in-person
second visit will sign the informed consent form and then be randomized to either
intervention (PRP) injection or placebo (injectable saline). The subject will be blinded
to the treatment allocation.
- Blinding: This is a single-blinded study. The subject will not know whether they are
giving or receiving PRP. The injector will be aware. The code will be broken only
after the study is complete. At this point all the research team will be made aware
of the results. During the study, the blinding may be broken only in emergencies
when knowledge of the subject's treatment group is necessary for further subject
management. When possible, the Investigator will discuss the emergency with the
monitor (the IRB) prior to unblinding.
The unblinded research staff will complete the randomization in REDCap to obtain the
treatment assignment. The subject will then undergo a venipuncture and 40 ml of blood
will be obtained. If assigned to intervention, the blood sample will be centrifuged for
15 minutes and spun down according to the PRP kit preparation protocol for the Arthrex
Angel system by trained and experienced research staff. On average, 2-4 cc of
leukocyte-rich PRP is produced per 40 cc of whole blood. If assigned to the placebo arm,
the blood sample will be properly disposed and the patient will receive 4 cc of
injectable saline.
Injections will be performed as follows using a 25 gauge needle by a trained licensed
provider with medical staff support. After positioning the patient and applying topical
lidocaine to the vagina (applied for a minimum of 10 minutes), the vaginal tissues will
be prepped and a total of 2-4 cc of allocated treatment will be injected into the distal
anterior vaginal wall approximately 3 cm from the urethral meatus and in the
peri-clitoral region. This injection will be superficial and just deep to the vaginal
epithelium.
Visit #3 Follow-up (4 weeks +/- 7 days via virtual visit) The subject will complete the
baseline questionnaire plus some additional questions. The subject will be asked about
any AEs. This visit will be conducted virtually.
Visit #4 Follow-up (6 months +/- 14 days via virtual visit) The subject will complete the
same questionnaire as in Visit #3. The subject will be asked about any AEs. This visit
will be conducted virtually, unless the subject requests to be seen in person.
The data collected during the study will include the subjects' responses to validated
questionnaires regarding sexual health/function. Basic demographic information will be
collected at the first visit. These data will be obtained via an online survey and stored
in a secure REDCap database.
Overall expected risks are anticipated to be rare in occurrence given no reported adverse
reactions after vaginal PRP injections. Anticipated and known risks will be disclosed to
the participants via the informed consent process. All study participants will be closely
monitored for adverse events and at 50% enrollment a safety monitor will review all AE
and safety data. All study investigators will receive training on the study protocol and
AE monitoring.
An adverse event (AE) will be defined as any unfavorable or unintended symptom or sign,
temporarily associated with an investigational intervention during the conduct of a
clinical trial. Pre-existing diseases or conditions will not be considered AEs unless
there is an increase in the frequency or severity, or change in the quality, of the
disease or condition. Events that occur in patients treated with placebo will also be
considered AEs. AEs will be recorded and serious adverse events will be considered an
adverse events that either: (1) results in death, (2) is life threatening, (3) requires
inpatient hospitalization, (4) results in permanent or significant disability or
incapacity, or (5) is another medically important condition. All serious adverse events
will be reported to the MedStar Health Research Institute (MHRI) IRB during which time
study enrollment will be stopped and the safety monitor will conduct a review to assess
safety of study continuation.
The investigators plan to recruit women via social media and in MedStar women's health
clinics. For social media, the investigators will post the flyer on the local Facebook
"Mom Group" pages. The investigators plan to post flyers in the waiting room and
restrooms of the clinics. The investigators will post the flyers in the break rooms at
MedStar Washington Hospital Center. Participants may also be referred by their clinical
provider. Once they have expressed interest in the study, a member of the research team
will contact them to screen for eligibility and discuss the study in detail. The
investigators plan to recruit 52 participants.
Our sample size achieves 80% power to detect non-inferiority using a one-sided t test
with significance level of 0.025. It is assumed that the true difference between the
means is 0, standard deviation of the mean difference (mean score at 6 week follow up
minus mean score at baseline) for both groups are considered to be 2.5 and 1.5 (based on
previous studies of FSFI), and margin of non-inferiority is -1.8. This would be achieved
with a sample size of 23 per treatment arm. Factoring in a dropout rate of 10%, each
treatment arm will be 26 participants.
Statistical analysis will be by intent-to-treat. Comparisons will be performed using a
t-test for continuous variables and chi-square or fischers exact for categorical
variables as appropriate. The investigators will use different variables to determine if
there are any significant associations using a univariate analysis that can be entered
into a multiple logistic regression model, which will allow for the determination of
independent predictors of outcome variables.