Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05769283
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-22
First Post:
2023-02-15
Brief Title:
Vaginal Injection of Platelet Rich Plasma for Sexual Function
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Vaginal Injection of Platelet Rich Plasma for Improvement of Sexual Function A Randomized Control Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP
Brief Summary:
The goal of this clinical trial is to learn about an injection of platelet rich plasma into the vaginal wall and around the clitoris The main questions it aims to answer are
To see if a PRP injection improves sexual satisfaction
To learn the effect of PRP injections on sexual function Participants will get assigned to getting a one time PRP injection or a placebo injection They will answer questionnaires about their sexual function at their first visit and their followup visit The investigators will then compare the two groups
To see if a PRP injection improves sexual satisfaction
To learn the effect of PRP injections on sexual function Participants will get assigned to getting a one time PRP injection or a placebo injection They will answer questionnaires about their sexual function at their first visit and their followup visit The investigators will then compare the two groups
Detailed Description:
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 participants whole blood to separate out red blood cells leaving a concentrated plasma product containing the participants 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 11 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 subjects 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 healthfunction 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 womens 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 0025 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 25 and 15 based on previous studies of FSFI and margin of non-inferiority is -18 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
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 11 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 subjects 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 healthfunction 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 womens 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 0025 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 25 and 15 based on previous studies of FSFI and margin of non-inferiority is -18 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None