Treatment of vaginal laxity in Chinese postpartum women Urological and Genital Diseases
Conditions
Interventions
This will be a randomized, sham-controlled clinical trial involving women diagnosed with vaginal laxity. Participants will be randomly assigned to either the temperature-controlled radiofrequency (TCR
Sponsors
Tsinghua University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Capable of understanding and voluntarily signing an informed consent form 2. Premenopausal women who are =18 years old 3. Have had at least one full-term vaginal delivery (>36 weeks of gestation) and are =12 months postpartum at the time of enrollment in this study 4. In the VLQ, the subject's self-perceived degree of vaginal laxity during intercourse is rated as "very loose," "loose," or "somewhat loose," and the degree of vaginal laxity measured by the researcher's digital examination is rated as "severe," "moderate," or "mild" 5. Cervical cytology results are normal 6. Willing to engage in vaginal intercourse at least once a week (note: this does not apply to situations where the subject must abstain from vaginal intercourse for at least one week after each study treatment) 7. Maintained a monogamous, heterosexual relationship for at least 6 months before study screening 8. The subject has a reasonable expectation, is capable of understanding, and can comply with the study procedures and all scheduled visit times 9. Women of childbearing age agree to use contraception throughout the study period
Exclusion criteria
Exclusion criteria: 1. Pregnancy, planning to become pregnant during the study period, or have given birth in the past 12 months 2. History of genital tract fistula, thin rectovaginal septum (approximately 1 cm or one finger width as assessed by the investigator), or history of fourth-degree perineal tear 3. Presence of an implanted cardiac pacemaker, any other implanted electromagnetic device, or metal implants (except dental implants) 4. Concomitant sexual dysfunction or vaginismus that affects sexual activity 5. Severe or progressive diseases who, in the investigator's judgment, pose a serious risk by participating in this clinical trial 6. Uncontrolled or unstable hypertension as determined by the investigator 7. Inflammation or unhealed wounds on the vulva and/or vagina 8. History of psychiatric conditions that, in the investigator's judgment, may affect study compliance and evaluation (e.g., depression, anxiety, bipolar disorder) 9. Underwent vaginal tightening surgery within the past 5 years, pelvic radiofrequency or laser treatment within the past year, or plans to receive such treatments during the study 10. Any other condition deemed unsuitable for enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in FSFI total scores is measured at baseline and at 12 weeks post-treatment for the intervention group, and at baseline and 12 weeks post-final sham treatment for the control group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sexual functioning measured using the Female Sexual Function Index (FSFI) questionnaire at weeks 3 and 6 post-initial treatment, and week 4 post-final treatment 2. Distress associated with impaired sexual function measured using the Female Sexual Distress Scale-Revised (FSDS-R) scale at weeks 3 and 6 post-initial treatment, and weeks 4 and 12 post-final treatment 3. The perception of vaginal laxity/density measured using the Vaginal Laxity Questionnaire (VLQ) at weeks 3 and 6 post-initial treatment, and weeks 4 and 12 post-final treatment 4. Sexual satisfaction from vaginal intercourse measured using the Sexual Satisfaction Questionnaire (SSQ) at weeks 3 and 6 post-initial treatment, and weeks 4 and 12 post-final treatment 5. Vaginal pressure change (resting and contractile pressures) measured using a perineometer at weeks 3 and 6 post-initial treatment, and weeks 4 and 12 post-final treatment 6. The degree of vaginal laxity measured using a digital assessment at weeks 3 and 6 post-initial treatment, and weeks 4 and 12 post-final treatment 7. Labial base length measured using a vernier caliper at weeks 3 and 6 post-initial treatment, and weeks 4 and 12 post-final treatment 8. Pigmentation will be evaluated by comparing baseline and post-treatment photographic records to identify any improvements. Elasticity will be scored using a tactile assessment ranging from 0 (indicating normal elasticity) to 3 (indicating poor elasticity). The assessments will be conducted at weeks 3 and 6 post-initial treatment, and weeks 6 and 12 post-final treatment. | — |
Countries
China
Contacts
Public ContactHui Shao
Outcome results
None listed