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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yara Sifri, MD
- Número de telefone: 978-273-1786
- E-mail: vaginalprp@gmail.com
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10029
- Recrutamento
- The Mount Sinai Hospital
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Contato:
- Yara Sifri, MD
- Número de telefone: 978-273-1786
- E-mail: vaginalprp@gmail.com
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Investigador principal:
- Charles Ascher-Walsh
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in total score of The Female Sexual Function Index (FSFI)
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Female Sexual Distress Scale-Revised (FSDS-R) total score
Prazo: 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)
Prazo: 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.
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Change in FSFI domain scores
Prazo: 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
Prazo: 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.
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Visual Analogue Scale (VAS)
Prazo: 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
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Number of participants with adverse events.
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY-25-00896
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
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