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Study on Evaluating Vaginal Wall Tissue Elasticity for the Diagnosis of Vaginal Laxity

Evaluation of the Biomechanical Characteristics of Female Vaginal Wall Tissue Based on Ultrasound Elastography and Its Application in the Diagnosis of Vaginal Laxity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114014
Enrollment
Unknown
Registered
2025-12-05
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Vaginal Laxity

Interventions

Control group aged 18–30 years (Study 1):None
Control group aged 31–40 years (Study 1):None
Control group aged 41–50 years (Study 1):None
Vaginal delivery group aged 18–30 years (Study 1):None
Vaginal delivery group aged 31–40 years (Study 1):None
Vaginal delivery group aged 41–50 years (Study 1):None
Healthy postmenopausal women aged 51–59 years (Study 1):None
Healthy postmenopausal women aged 60–65 years (Study 1):None
Control group (Study 2):None
Mild vaginal laxity group:None
Moderate vaginal laxity group:None
Severe vaginal laxity group:None

Sponsors

Peking University Shenzhen Hospita
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Study 1 1.Women aged 18–65 years 2.No complaint of vaginal laxity and VLQ score >= 4 3.Vaginal introitus admitting = 6 months that negatively impacts quality of life 3. Vaginal Laxity Questionnaire (VLQ) score <=3 4. Gynecologic digital examination showing moderate-to-severe laxity (i.e., vagina easily accommodates three or four fingers) 5. Able to understand the study and voluntarily provide written informed consent.

Exclusion criteria

Exclusion criteria: Study 1 1.Currently pregnant, breastfeeding, or = stage II (POP-Q stage > I) 4. Moderate-to-severe stress urinary incontinence (SUI) or other bothersome urinary incontinence requiring treatment 5. Major pelvic surgery (e.g.hysterectomy, pelvic-floor reconstruction, anti-incontinence procedures) 6. History of pelvic malignancy or pelvic radiotherapy 7. Known systemic disorders affecting connective tissue or muscle function (e.g.Ehlers-Danlos syndrome, Marfan syndrome, systemic lupus erythematosus, multiple sclerosis) 8. Acute genital-tract infection at time of assessment 9. Imaging showing large pelvic masses that distort pelvic-floor anatomy (e.g. uterine fibroids or ovarian cysts > 5 cm) 10. Current use of hormonal medications affecting estrogen levels (e.g.oral contraceptives, hormone-replacement therapy) 11. Unable to tolerate trans-vaginal ultrasound or perform a Valsalva maneuver Study 2 1. Pregnancy, breastfeeding, or = III), as it constitutes a distinct disease entity that would severely confound measurements 3. Previous pelvic-floor reconstruction, anti-incontinence, or vaginal cosmetic surgery 4. History of pelvic malignancy or radiotherapy. 5. Systemic disorders affecting connective tissue or neuromuscular function. 6. Acute genital tract infection. 7. Inability to complete questionnaires or cooperate with ultrasound examination.

Design outcomes

Primary

MeasureTime frame
Ultrasonic elastic modulus of the vaginal wall;

Secondary

MeasureTime frame
Vaginal wall thickness;Microcirculation Quantification;Levator ani hiatus;

Countries

China

Contacts

Public ContactWang Yue

Peking University Shenzhen Hospital

sonoview@163.com+86 136 8880 5923

Outcome results

None listed

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