The efficacy and safety of temperature-controlled radiofrequency for the treatment of vaginal laxity in Chinese postpartum women
| ISRCTN | ISRCTN35181035 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35181035 |
| Secondary identifying numbers | SDSLSPRLY2023/1.0 |
- Submission date
- 15/07/2024
- Registration date
- 18/07/2024
- Last edited
- 17/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Vaginal laxity (VL) is a common type of pelvic floor dysfunction disorder in women, associated with factors such as age, hormones, and childbirth, and it is frequently seen in postpartum women. Currently, vaginal tightening surgery is a more widely used clinical treatment method, but it is invasive. In recent years, non-invasive treatment methods including temperature-controlled radiofrequency (TCRF) have become the primary choice for patients seeking treatment. Radiofrequency can produce a heating effect that stimulates fibroblasts to generate new collagen and elastic fibers, improving local blood circulation, thereby achieving vagina tightening and vulva rejuvenating. However, there are currently few studies on the treatment of postpartum VL in Chinese women using this new TCRF device. This study aims to determine if the treatment is effective and safe for new mothers with VL by comparing it to sham (control) treatments. The study will include multiple locations, randomly assign participants, and keep the women unaware of which treatment they receive.
Who can participate?
Premenopausal women over the age of 18 with a history of at least one full-term vaginal delivery
What does the study involve?
Participants will be randomly assigned to either the TCRF treatment group or the sham control group. In this study, participants will not be informed about the status of the radiofrequency device's energy application, ensuring a blinded assessment of the treatment's effects. Radiofrequency thermotherapy device (SL ThermiRF I), with treatments administered once every three weeks for a total of three sessions, both vaginal and external genital areas are treated for 20-30 minutes each session, with a treatment temperature range of 35℃ to 42℃ (±3℃).
What are the possible benefits and risks of participating?
Participants may experience a reduction in VL, leading to enhanced sexual satisfaction and overall quality of life. However, it is essential to be aware of potential risks, such as discomfort, pain, swelling, and injection at the treatment site.
Where is the study run from?
The study was conducted at four sites in China, including Beijing Tsinghua Changgung Hospital (China)
When is the study starting and how long is it expected to run for?
September 2021 to December 2023
Who is funding the study?
Shandong Silin Pharmaceutical Technology Co., Ltd
Who is the main contact?
Dr Hui Shao, sh.2020@tsinghua.org.cn
Contact information
Public, Scientific, Principal Investigator
NO.168 Litang Road Changping District Beijing,China
Beijing
102218
China
 ORCID ID |
0009-0003-5678-8132 |
|---|---|
| Phone | +86 15770734271 |
| sh.2020@tsinghua.org.cn |
Study information
| Study design | Randomized prospective sham-controlled multicenter clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format |
| Scientific title | A prospective randomized controlled clinical study on the treatment of postpartum vaginal laxity in women with a novel temperature-controlled radiofrequency technology |
| Study acronym | TTCRF |
| Study hypothesis | Transcutaneous temperature-controlled radiofrequency (TTCRF) treatment is more effective in improving vaginal laxity compared to a sham control. |
| Ethics approval(s) |
1. Approved 24/02/2022, Ethics Committee of the Chinese People's Liberation Air Force Medical Center (No.30 Fu-cheng Road, Haidian District, Beijing, 100142, China; +86 010-66928575; kjtsll@126.com), ref: AF-07.08/03.3 2. Approved 18/03/2022, Ethics Committee of Beijing Tsinghua Changgeng Hospital (NO.168 Litang Road Changping District, Beijing, 102218, China; +86 010-56118567; IRB@btch.edu.cn), ref: 22191-2-01 3. Approved 18/04/2022, Medical Ethics Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University (No. 201 Community Service Center, Tuanjiehu Street, Wutaio, Tuanjie Hubei, Beijing, 100026, China; +86 010-85968407; fcyylunli@163.com), ref: IEC-C29-V02-FJI 4. Approved 25/03/2022, Ethics Committee of Beijing Friendship Hospital, Capital Medical University (No. 95 Yong'an Road, Xicheng District, Beijing., Beijing, 100050, China; 010-63139850; yd277@126.com), ref: 2022-P1-械-005-01 |
| Condition | Treatment of vaginal laxity in Chinese postpartum women |
| Intervention | 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 (TCRF) treatment group or the sham control group. Randomization will be conducted using a computer-generated random sequence using a central randomization system for dynamic enrollment of participants. An Interactive Web Response System (IWRS) automatically assigns participants to groups based on the order of enrollment. The study employs stratified block randomization by center, maintaining a 1:1 ratio of participants in the treatment group to the control group. Radiofrequency thermotherapy device (SL ThermiRF I), with treatments administered once every three weeks for a total of three sessions, both vaginal and external genital areas are treated for 20-30 minutes each session, with a treatment temperature range of 35℃ to 42℃ (±3℃). The expected duration of the study for each subject is approximately 20 weeks, including a screening period of up to 2 weeks and a follow-up period of 18 weeks. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Radiofrequency thermotherapy device (SL ThermiRF I) |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/09/2021 |
| Overall study end date | 29/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 150 |
| Total final enrolment | 150 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 24/02/2022 |
| Recruitment end date | 11/08/2023 |
Locations
Countries of recruitment
- China
Study participating centres
Beijing
100142
China
Beijing
102218
China
Beijing
100026
China
Beijing
100050
China
Sponsor information
Hospital/treatment centre
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, NO.168 Litang Road Changping District
Beijing
102218
China
| Phone | +86 010-56119002 |
|---|---|
| 870398654@qq.com | |
| Website | https://www.btch.edu.cn/ |
"ROR" |
https://ror.org/03cve4549 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository: https://edc.clinflash.com. The type of data stored is individual participant data (IPD) including demographic details, treatment received, and outcomes measured. |
Editorial Notes
16/07/2024: Study's existence confirmed by the Medical Ethics Committee of Beijing Obstetrics and Gynecology Hospital, of Capital Medical University.
