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.

Study Overview

• Status: Recruiting
• Conditions: Sexual Dysfunction; Female Sexual Dysfunction; Physiological
• Intervention / Treatment: Biological: Autologous Platelet-Rich Plasma (PRP) Injection; Other: Sterile saline injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yara Sifri, MD; Phone Number: 978-273-1786; Email: vaginalprp@gmail.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • The Mount Sinai Hospital
      • Contact: Yara Sifri, MD; Phone Number: 978-273-1786; Email: vaginalprp@gmail.com
      • Principal Investigator: Charles Ascher-Walsh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: Autologous Platelet-Rich Plasma (PRP) Injection; 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).	Other: Sterile saline injection; 4-5cc sterile saline injected at the same location, depth, and technique as the PRP arm, following a blood draw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total score of The Female Sexual Function Index (FSFI)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Female Sexual Distress Scale-Revised (FSDS-R) total score	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)	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	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	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)	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.	Number of participants with treatment related adverse events post injection.	From injection through 6 months.

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 29, 2026
• First Submitted That Met QC Criteria: October 29, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: STUDY-25-00896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No