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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yara Sifri, MD
- Número de teléfono: 978-273-1786
- Correo electrónico: vaginalprp@gmail.com
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10029
- Reclutamiento
- The Mount Sinai Hospital
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Contacto:
- Yara Sifri, MD
- Número de teléfono: 978-273-1786
- Correo electrónico: vaginalprp@gmail.com
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Investigador principal:
- Charles Ascher-Walsh
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Comparador falso: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in total score of The Female Sexual Function Index (FSFI)
Periodo de tiempo: Baseline, 6 weeks, and 6 months after injection.
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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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Female Sexual Distress Scale-Revised (FSDS-R) total score
Periodo de tiempo: 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.
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Patient Global Impression of Improvement (PGI-I)
Periodo de tiempo: 6 weeks and 6 months after injection.
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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.
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Change in FSFI domain scores
Periodo de tiempo: 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.
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Stress Urinary Incontinence Symptom Frequency
Periodo de tiempo: Baseline, 6 weeks, and 6 months from injection visit.
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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.
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Visual Analogue Scale (VAS)
Periodo de tiempo: Day of injection - before speculum insertion, during injection, and within 5 minutes after injection
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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
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Number of participants with adverse events.
Periodo de tiempo: From injection through 6 months.
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Number of participants with treatment related adverse events post injection. |
From injection through 6 months.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY-25-00896
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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