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Efficacy and Safety of Cross-linked Dextran Submucosal Injection in Women with Vaginal Laxity

Efficacy and Safety of Cross-linked Dextran (LiCOL GOLD®) Submucosal Injection in Women with Vaginal Laxity: A Randomized, Controlled, Single-Blinded, Multicenter Study with 24-Week Follow-Up

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0012159
Enrollment
126
Registered
2026-06-23
Start date
2019-06-18
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

None listed

Interventions

Medical Device : In the experimental group, LiCOL GOLD®—a soft-tissue augmentation agent whose active component is cross-linked dextran microparticles suspended in hydroxypropyl methylcellulose—was ad

Sponsors

Kangdong Sacred Heart Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Premenopausal adult women aged 21–55 years with a VLQ score =3 during intercourse were eligible. Only women who had undergone at least one vaginal delivery at least one year before enrollment were included. All participants agreed to refrain from any urological or gynecological treatment that could affect the study during the trial period.

Exclusion criteria

Exclusion criteria: Subjects were excluded if they had a history of psychiatric disorder; congenital or acquired vaginal malformation; current use of anticoagulants within four weeks before enrollment; concomitant treatment for vaginal laxity at another institution (e.g., RF therapy); pelvic organ prolapse of stage III or higher; an untreated sexually transmitted infection; or were less than one year postpartum.

Design outcomes

Primary

MeasureTime frame
the proportion in whom the VLQ (Vaginal Laxity Questionnaire) score improved to =5

Secondary

MeasureTime frame
Changes in vaginal squeeze pressure

Countries

Korea, Republic of

Contacts

Public ContactKyungtae Ko

Kangdong Sacred Heart Hospital

palindromes@hanmail.net+82-2-2224-2290

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 3, 2026