PRP for Sexual Function
Vaginal Injection of Platelet Rich Plasma for Sexual Dysfunction: A Randomized Control Trial
This randomized, single-blinded, sham-controlled trial evaluates whether a single injection of autologous platelet-rich plasma (PRP) into the distal anterior vaginal wall improves sexual function in women with sexual dysfunction. Sixty participants with a Female Sexual Function Index (FSFI) total score of 26.5 or lower are randomized 1:1 to PRP injection or sterile saline injection. Sexual function, sexual distress, global impression of change, and urinary incontinence symptoms are assessed at baseline, 6 weeks, and 6 months after injection.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Participants complete baseline questionnaires at screening, followed by an in-person injection visit. All participants undergo a 40 mL whole blood draw to preserve blinding. For participants randomized to PRP, the blood is processed using a double-spin centrifugation protocol; for participants randomized to the control arm, the blood sample is discarded. Then 4 cc of PRP or sterile saline is injected with a 25-gauge needle just deep to the vaginal epithelium of the distal anterior vaginal wall, approximately 3 cm from the urethral meatus. Procedural pain is recorded before speculum insertion, during injection, and within 5 minutes after injection. Follow-up assessments at 6 weeks (±7 days) and 6 months (±14 days) may be completed virtually. Randomization uses permuted blocks of variable size (2 and 4), implemented in REDCap. After completing the 6-month follow-up, participants in the saline arm are offered PRP injection at no cost.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Yara Sifri, MD
- Telefonnummer: 978-273-1786
- E-post: vaginalprp@gmail.com
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10029
- Rekrytering
- The Mount Sinai Hospital
-
Kontakt:
- Yara Sifri, MD
- Telefonnummer: 978-273-1786
- E-post: vaginalprp@gmail.com
-
Huvudutredare:
- Charles Ascher-Walsh
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Female, 18 years of age or older, presenting with sexual dysfunction
- FSFI total score ≤ 26.5
- English speaking and literate
Exclusion Criteria:
- Unwilling or unable to provide informed consent
- Pregnant or less than 12 weeks postpartum
- Known history of bleeding disorder
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Participants receiving a PRP Injection
Participants will receive a single injection of 4-5cc autologous platelet-rich plasma into the distal anterior vaginal wall after blood draw. |
Whole blood draw of 40 mL is processed by double-spin centrifugation; 4 cc PRP is injected with a 25-guage needle just deep to the epithelium of the distal anterior vaginal wall, about 3 cm from the urethral meatus, after topical lidocaine. |
|
Sham Comparator: Participants receiving Saline Injection
Participants will receive a single injection of 4-5cc sterile saline into the distal anterior vaginal wall after blood draw (blood sample will be discarded). |
4-5cc sterile saline injected at the same location, depth, and technique as the PRP arm, following a blood draw. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in total score of The Female Sexual Function Index (FSFI)
Tidsram: Baseline, 6 weeks, and 6 months after injection.
|
The Female Sexual Function Index (FSFI) is a 19-item questionnaire to evaluate female sexual function and dysfunction across 6 domains: desire, arousal, lubrication, orgasm, satisfaction, pain. Total scores range from 2.0-36.0; higher scores indicate better sexual function, and scores ≤26.5 indicate sexual dysfunction. |
Baseline, 6 weeks, and 6 months after injection.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Female Sexual Distress Scale-Revised (FSDS-R) total score
Tidsram: Baseline, 6 weeks, and 6 months after injection.
|
The Female Sexual Distress Scale-Revised (FSDS-R) is a 13-item questionnaire used to measure sexually related personal distress in adult women. Answers are scored on a scale of 0-4, with total scores ranging 0-52; higher scores indicate greater sexual distress, and scores ≥11 indicate clinically significant distress. |
Baseline, 6 weeks, and 6 months after injection.
|
|
Patient Global Impression of Improvement (PGI-I)
Tidsram: 6 weeks and 6 months after injection.
|
Patient Global Impression of improvement (PGI-I) is a single item scale assessing a patient's perception of change in their condition following treatment. The assessment is scored 1-7. Lower scores mean greater improvement. Scores of 1-3 are defined as a response. |
6 weeks and 6 months after injection.
|
|
Change in FSFI domain scores
Tidsram: Baseline, 6 weeks, and 6 months from injection visit.
|
The Female Sexual Function Index (FSFI) is a 19-item questionnaire to evaluate female sexual function and dysfunction across 6 domains: desire, arousal, lubrication, orgasm, satisfaction, pain. Domains are scored 0 (or 1.2) to 6.0. Total scores range from 2.0-36.0. Higher scores indicate better sexual function. |
Baseline, 6 weeks, and 6 months from injection visit.
|
|
Stress Urinary Incontinence Symptom Frequency
Tidsram: Baseline, 6 weeks, and 6 months from injection visit.
|
Among participants reporting incontinence: leakage frequency with activity is scored on a scale of 0 (never) to 5 (several times per day). Higher scores indicate more frequent leakage. |
Baseline, 6 weeks, and 6 months from injection visit.
|
|
Visual Analogue Scale (VAS)
Tidsram: Day of injection - before speculum insertion, during injection, and within 5 minutes after injection
|
The Visual Analogue Scale (VAS) is a single item questionnaire used to measure pain intensity. The assessment is scored on a scale of 0-10; higher scores indicate worse pain. |
Day of injection - before speculum insertion, during injection, and within 5 minutes after injection
|
|
Number of participants with adverse events.
Tidsram: From injection through 6 months.
|
Number of participants with treatment related adverse events post injection. |
From injection through 6 months.
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY-25-00896
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individual participant data contain sensitive sexual-health information, and the informed consent does not provide for sharing individual-level data. Results will be shared in aggregate through publication.
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