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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Yara Sifri, MD
- 전화번호: 978-273-1786
- 이메일: vaginalprp@gmail.com
연구 장소
-
-
New York
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New York, New York, 미국, 10029
- 모병
- The Mount Sinai Hospital
-
연락하다:
- Yara Sifri, MD
- 전화번호: 978-273-1786
- 이메일: vaginalprp@gmail.com
-
수석 연구원:
- Charles Ascher-Walsh
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
가짜 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in total score of The Female Sexual Function Index (FSFI)
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Female Sexual Distress Scale-Revised (FSDS-R) total score
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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.
기간: From injection through 6 months.
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Number of participants with treatment related adverse events post injection. |
From injection through 6 months.
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- STUDY-25-00896
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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미국에서 제조되어 미국에서 수출되는 제품
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