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A randomized controlled trial of platelet-rich plasma therapy for female vaginal laxity

A randomized controlled trial of platelet-rich plasma therapy for female vaginal laxity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097442
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-02-20
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar Relaxation Syndrome

Interventions

Platelet-rich plasma (PRP) group:The injection sites are the anterior vaginal wall, the posterior vaginal wall, and the top of the vagina, using a multi-point injection technique. Each patient receive
Laser Group:1) Apply epinumbing ointment to the vulva: thickness 2-3mm, plastic wrap for 30-40 minutes
2) Install a straight-haired pixel wristband (9X9/7X7) and a yellow visco, and connect a white blowpipe
3) Cleaning anesthetic and disinfection of the vulva
4) The operator wears laser protective glasses, fully inserts the probe into the tip of the vagina, and emits the laser at an energy density of 10 mJ and a spot density of 10–15%. After the probe is r
5) Subsequently, the probe steps back one degree from the mark on the probe body and repeats the above process. A total of 3–4 laser scans were performed throughout the vagina. 6) Tightening treatment
A small crust will form within 24 hours after treatment, allowing it to fall off naturally and cannot be artificially peeled
Cannot share a room for 3 days. Treatment course: 3 sessions/session, 4 weeks apart.

Sponsors

West China Second Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1.Patients with a confirmed clinical diagnosis of VRS, following the diagnostic criteria outlined in the Guidelines for the Diagnosis and Treatment of Female Vaginal Laxity. 2.No relevant treatment received in the past two weeks. 3.Complete clinical data and follow-up compliance. 4.Willingness to participate in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.History of protein allergy. 2.Acute inflammatory phase of the genitourinary system. 3.Presence of hematologic disorders, immune dysfunction, or malignancies. 4.Pregnancy. 5.Severe systemic medical conditions affecting daily life (e.g., diagnosed severe cardiovascular diseases or immune system disorders). 6.Psychological or psychiatric disorders (e.g., depression) that prevent completion of follow-up.

Design outcomes

Primary

MeasureTime frame
CVFSFI score;vaginal laxity questionnaire (VLQ) score;Vaginal Health Index score;

Secondary

MeasureTime frame
sexual satisfaction questionnaire (SSQ) score;Treatment satisfaction;Pelvic floor muscle electromyography (EMG) values;Adverse events;

Countries

China

Contacts

Public ContactWei Dongmei

West China Second Hospital of Sichuan University

weidongmei@scu.edu.cn+86 189 8215 0655

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026