A Randomized Controlled Trial Comparing Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women
Phase: NA
Conditions: Vaginal Laxity
Sponsor: Mahidol University

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Clinical Trial Protocol  
Based on SPIRIT 2013 checklist (https://doi.org/10.7326/0003-4819-158-3-201302050-00583)    
Study Title (English):  
A randomized controlled trial comparing fractional bipolar radiofrequency therapy Vs sham for treatment 
of vaginal laxity in premenopausal women. 
Sponsor or planned sponsor, grant, scholarship <if applicable>: 
- The budget proposal includes a plan to seek funding from the Faculty of Medicine, Ramathibodi 
Hospital, Mahidol University 
- The fractional radiofrequency devices and the sham applicators will be provided through 
sponsorship by Morpheus8V (InMode) company 
Conflict of Interest: 
- No  
Study sites (list all as planned):  
- Outpatient department – Female Pelvic Medicine and Reconstructive Surgery clinic (FPMRS clinic), 
Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital 
Trial registration: 
- The trial is intended to be registered on www.clinicaltrials.gov. 
Background and Significance:  
           Vaginal laxity is a prevalent concern among premenopausal women today. A retrospective cohort 
study found that 24% of women reported experiencing vaginal laxity.1 According to the IUGA/ICS 2018 
definition, vaginal laxity is characterized by a sensation of looseness in the vagina.2 The relationship 
between vaginal laxity (VL) and childbirth is not entirely clear, but it is increasingly recognized that vaginal 

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delivery can contribute to trauma in the pelvic floor. Symptoms of vaginal laxity include loose vaginal 
tissue and other organs that are not displaced or pressing against the vagina, which differ from those 
associated with pelvic organ prolapse.3 The laxity of vulvovaginal tissue can arise from several factors, 
including natural aging, childbirth, genetic predispositions, and trauma. These factors can result in common 
symptoms such as stress urinary incontinence, atrophic vaginitis, dyspareunia, or dissatisfaction with 
appearance.4 Therefore, this condition should not be overlooked, as it can have a substantial impact on a 
woman's quality of life, resulting in discomfort, diminished sexual satisfaction, and emotional distress.5 
          There are several management modalities for the treatment of vaginal laxity, such as pelvic floor 
muscle training, energy-based devices, and surgical management. As of now, no studies have specifically 
assessed the application of pelvic floor muscle training (PFMT) for the treatment of vaginal laxity.1 
Moreover until now, there are no standard treatment for vaginal laxity in the current guidelines. However, 
energy-based devices are common modalities for improving vaginal laxity nowadays, which can be 
categorized into ablative fractional laser therapies, such as the ablative CO2 laser, and non-ablative 
therapies like Erbium-doped yttrium-aluminum-garnet (Er:YAG) and radiofrequency therapy.3 
Principle of bipolar radiofrequency therapy 
               
 
           Bipolar technology refers to an electrosurgical device in which the electrical current flows between 
two active electrodes positioned closely together. In bipolar devices, both electrodes produce a similar 
thermal effect and are applied to the area of tissue being treated. These devices generate larger thermal 
zones and are commonly utilized in electro-coagulators. The advantage of bipolar systems is the 
localization of all RF energy in the treatment zone.6 
           Fractional bipolar radiofrequency therapy has emerged as a promising minimally invasive treatment 
modality. This non-ablative approach uses fractional RF technology with microneedles to deliver thermal 
injury to the subdermis, stimulating collagen production, promoting tissue remodeling and improving tissue 
tightening, potentially addressing symptoms associated with vaginal laxity.7 Recent advancements in RF 
technology have led to its increasing use in aesthetic and gynecological applications. Evidence suggests 
that RF microneedling effectively remodels subdermal fat and improves skin firmness.13 However, no 
previous study has been conducted on the treatment of vaginal laxity using fractional bipolar 

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radiofrequency (with microneedling), highlighting the need for rigorous scientific evaluation to provide 
conclusive evidence on its effectiveness, including improvements in sexual function and safety.3  
            Additionally, the use of 3D transvaginal ultrasound to measure vaginal wall thickness is still limited 
in clinical studies. It is necessary to investigate whether fractional bipolar radiofrequency can improve 
vaginal wall thickness and explore the association between vaginal wall thickness and the clinical 
presentation of vaginal laxity in patients. 
           This study aims to address this gap by conducting a first randomized controlled trial to compare 
the efficacy of fractional bipolar radiofrequency therapy with a sham treatment in premenopausal women. 
By employing a methodological approach, this research seeks to contribute valuable insights into the 
clinical benefits of fractional bipolar radiofrequency therapy, ultimately guiding future treatment strategies 
for vaginal laxity. 
Review literatures:  
1. The efficacy and safety of a combined multipolar radiofrequency with pulsed 
electromagnetic field technology for the treatment of vaginal laxity: a double‐blinded, 
randomized, sham‐controlled trial8 (Lasers in Medical Science, 2022)  
            This study aimed to evaluate the efficacy and safety of a multipolar RF and pulsed 
electromagnetic field-based device (PEMF) compared to a sham treatment for vaginal laxity. Thirty-two 
premenopausal women with self-reported vaginal laxity and at least one vaginal delivery were randomized 
into two groups: active (RF + PEMF) and sham. Both groups underwent three vaginal treatments at three-
week intervals. Outcomes were assessed using the Vaginal Laxity Questionnaire (VLQ), perineometer 
measurements, and Brink score at baseline, 4 weeks, and 12 weeks post-treatment. Additionally, vaginal 
histology, Female Sexual Function Index (FSFI), patient satisfaction, pain, and adverse events were 
evaluated. 
             Results showed that the active group had significantly improved VLQ scores compared to the 
sham group (p < 0.001), with 50% of the active group reporting no vaginal laxity at the final follow-up, 
compared to 12% in the sham group (p = 0.054). The active group also demonstrated significant 
improvements in perineometer measurements, Brink scores (p < 0.001), FSFI scores (p < 0.05), and patient 
satisfaction (p < 0.001). Mild adverse effects such as pain and burning were similar between groups, but 
itching was significantly more frequent in the sham group (p = 0.014). Six participants consented to undergo 
pre- and post-treatment vaginal wall biopsies for histological analysis. Punch biopsies (3 mm.) were 

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collected two weeks prior to the initial treatment and 12 weeks after completing the third session. The 
formalin-fixed vaginal tissue samples were stained with hematoxylin and eosin (H&E) and further processed 
with Verhoeff-van Gieson stain to evaluate elastic fibers. 
             Histological analysis after RF + PEMF treatment showed neocollagenesis, neoelastogenesis, and 
neoangiogenesis. In conclusion, RF + PEMF therapy was safe and effective in improving vaginal laxity, 
enhancing pelvic floor muscle strength, and boosting female sexual function for at least 12 weeks post-
treatment, with confirmed histological improvements. 
Similarity: This randomized controlled trial (RCT) investigates premenopausal women with vaginal laxity in 
Thailand. 
Difference: This RCT compares the effectiveness of a multipolar radiofrequency (RF) device with a pulsed 
electromagnetic field-based device (PEMF), whereas my research utilizes a fractional bipolar radiofrequency 
device. This distinction highlights the use of two different types of radiofrequency therapies. 
Importance: This finding is significant for estimating the improvement in vaginal laxity within the sham 
group in the study, which demonstrated that 12% of participants reported no vaginal laxity three months 
post-treatment. This contrasts with the active group, where 50% reported no vaginal laxity at the final 
follow-up (p = 0.054). This study also performed vaginal biopsies on volunteer participants for histological 
analysis at the study center located in Ramathibodi Hospital, with no significant complications reported. 
2. Radiofrequency Treatment of Vaginal Laxity after Vaginal Delivery: Nonsurgical Vaginal 
Tightening9 (J Sex Med, 2010) 
             This pilot study aimed to evaluate the safety and tolerability of nonsurgical radiofrequency (RF) 
thermal therapy for treating vaginal introitus laxity post-delivery and to assess the utility of self-report 
questionnaires in evaluating the device's subjective effectiveness. The study involved treating 24 women 
once with reverse gradient RF energy (75–90 joules/cm²) delivered through the vaginal mucosa. Follow-up 
assessments were conducted at 10 days, 1 month, 3 months, and 6 months. Safety was assessed through 
pelvic examinations and adverse event reports. Effectiveness was evaluated using modified Female Sexual 
Function Index (mv-FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and newly designed Vaginal Laxity 
and Sexual Satisfaction Questionnaires, as well as the Global Response Assessment. 
             The RF treatment was well-tolerated, with no reported adverse events or need for topical 
anesthetics. Self-reported vaginal tightness improved in 67% of participants at one month and 87% at six 

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months (P < 0.001). Mean sexual function scores increased significantly from 27.6 ± 3.6 before treatment to 
32.0 ± 3.0 at six months (P < 0.001), and FSDS-R scores decreased from 13.6 ± 8.7 to 4.3 ± 5.0 (P < 0.001). 
Among 12 women who initially reported reduced sexual satisfaction, all showed sustained improvements 
on the Sexual Satisfaction Questionnaire at six months (P = 0.002). To conclude, RF treatment was well-
tolerated and demonstrated a strong safety profile over six months. Subjective improvements in vaginal 
tightness, sexual function, and reduced sexual distress were reported, suggesting that further studies are 
warranted. 
Similarity: This incorporates subjective assessments, including self-reported vaginal tightness and 
questionnaires evaluating sexual function, such as the Female Sexual Function Index (FSFI), the Female 
Sexual Distress Scale - Revised (FSDS-R), and a sexual satisfaction questionnaire. 
Difference: This procedure is conducted using a different type of radiofrequency technology from my 
research proposal. 
3. Safety, tolerability and short‐term efficacy of transvaginal fractional bipolar radiofrequency 
therapy for symptoms of stress and or mixed incontinence in conjunction with genitourinary 
syndrome of menopause10 (Neurourol Urodyn. 2023) 
           The study introduces the application of radiofrequency (RF) energy through microneedling as a 
method to enhance collagen and elastin remodeling in the superficial vaginal mucosa, with the aim of 
restoring elasticity and moisture. This research is unique as it reports the use of microneedling to deliver RF 
energy directly to the vaginal canal, following a novel approach where needles penetrate at depths of 1, 2, 
or 3 mm. The objective was to evaluate the safety and short-term outcomes of a single fractional RF 
treatment on a cohort of twenty women experiencing stress urinary incontinence (SUI) or mixed urinary 
incontinence (MUI) alongside genitourinary syndrome of menopause (GSM). Using the EmpowerRF platform 
with the Morpheus8V applicator, RF energy was applied via 24 microneedles, and various outcomes were 
assessed through clinical tests and questionnaires at 1, 3, and 6 months post-treatment. Results showed 
significant improvements across all eight measured outcomes, including various urinary symptoms, at each 
follow-up compared to baseline.  
          Five biopsies were conducted, revealing that histological examination of the vaginal mucosa three 
months after treatment showed an increase in the density of elastic fibers compared to baseline samples. 
Both superficial and deeper layers of elastic fibers were identified. Additionally, the biopsies indicated no 

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damage to the submucosal collagen layer and no evidence of scar tissue formation following the 
treatment, confirming that fractional RF treatment did not have any adverse effects 
         The study concludes that fractional RF energy treatment delivered vaginally is safe, well tolerated, 
and offers short-term benefits for women suffering from SUI and/or MUI in conjunction with GSM. 
Similarity: This study represents the first randomized controlled trial (RCT) utilizing a fractional bipolar 
radiofrequency device combined with microneedling for intravaginal treatment, a methodology that aligns 
with the radiofrequency treatment employed in my research. In this trial, the protocol involves 
administering a single session with the fractional bipolar radiofrequency device, followed by an evaluation 
of the outcomes.  
Difference: The population in the RCT study consists of women with coexisting stress or mixed urinary 
incontinence (MUI) and genitourinary syndrome of menopause. In contrast, my RCT focuses on 
premenopausal women with vaginal laxity, so the main difference lies in the objective of the study and the 
outcome measurements. 
4. Vaginal wall thickness as potential biomarker of vaginal health. A proposal for standardized 
ultrasound measurement using three-dimensional transvaginal ultrasound11 (J Clin 
Ultrasound, 2023) 
         The pilot study in ten patients from Spain proposes a standardized method utilizing three-
dimensional (3D) transvaginal ultrasound to measure vaginal wall thickness as a biomarker of vaginal 
health. The methodology is outlined as follows: First, the vagina is filled with gel. An endovaginal 
transducer is then inserted into the vagina, reaching up to the mid-third. In the sagittal plane, the cervix 
and vaginal fornices are visualized, and a 3D volume of the upper third of the vagina is captured. Using the 
tomographic ultrasound imaging function in the sagittal plane, with the posterior vaginal fornix as the 
reference point, at least three axial planes of the vagina are obtained, spaced 1 cm apart. Vaginal wall 
thickness is measured at a distance of 2 cm from the posterior vaginal fornix at the 12, 3, 6, and 9 o'clock 
positions. The study demonstrates high reproducibility of these measurements, establishing that 
assessments of vaginal wall thickness can be performed reliably. 

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Similarity: This pilot study proposes a reliable method for measuring vaginal wall thickness, demonstrating 
high reproducibility of measurements. 
Limitations of this study: The study is limited by the small number of cases (only 10 patients) and the 
lack of correlation with patients' clinical data.  
Objectives:  
Primary Objective:   
- To evaluate and compare the efficacy of fractional bipolar radiofrequency therapy versus a sham 
treatment for vaginal laxity in premenopausal women.  
Secondary Objectives (if any): 
- To evaluate patient satisfaction and changes in sexual function before and after fractional bipolar 
radiofrequency therapy Vs sham treatment. 
- To assess alterations in vaginal thickness based on 3D transvaginal ultrasound before and after 
fractional bipolar radiofrequency therapy Vs sham treatment. 
- To evaluate any potential side effects or adverse events associated with intravaginal fractional 
bipolar radiofrequency therapy. 
Study design/methodology: 
Study design: A double-blind, randomized controlled trial 
Study flow diagram 
 
CONSORT Flow Diagram 

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Study Population:  
- Premenopausal women with clinically diagnosed vaginal laxity who are sexually active.  
Inclusion Criteria: 
- Premenopausal women  
- Age 20-55 years 
- Reported symptoms of vaginal looseness with a score of at least 1 on The Vaginal Laxity 
Questionnaire (VLQ) 
- Sexually active (≥1 time/month) 
- Willing to undergo vaginal energy-based treatment and attend follow-up visits 3 months after 
treatment 

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Exclusion criteria 
- Presence of sexually transmitted diseases or active genital lesions 
- Currently pregnant or planning for conception during study period 
- Pelvic organ prolapse (POP ≥ Stage II) 
- Previous treatment for vaginal laxity with modalities other than pelvic floor muscle training 
- Currently using intrauterine devices for contraception 
- Presence of any active electrical implant such as pacemaker, internal defibrillator 
- Current condition of genital cancer 
 
 
 
Treatment allocation and concealment: 
 
         Patients who meet the inclusion criteria will be randomly assigned to treatment group and sham 
group using a block randomization method with a 1:1 treatment ratio. The sequence generation will be 
provided by a senior statistician from the Clinical Epidemiology and Biostatistics section at Ramathibodi 
Hospital. Random sequences will be created using Stata version 18, an automated process without 
investigator involvement. One research team member from the FPMRS department will be responsible for 
allocation but will not participate in the treatment procedure or the evaluation process. 
Blinding (masking): 
 
            This study employs a double-blind design to minimize bias by blinding both the patients and 
evaluators. All patients, regardless of group, will remain blinded. The sham group will receive treatment 
with a specialized sham device that mimics the treatment group's equipment. There are no differences in 
the design of the tip device, the auditory signal (beeping), or the pulse count display. The physician 
managing the allocation, will not be involved in the treatment procedures or the assessment process. 
Subjective outcomes, such as questionnaires (VLQ, FSFI, FGSIS, ICIG-VS, PGI-I), will be assessed by a research 
assistant from the urogynecology clinic who is blinded to the group assignments, ensuring she is unaware 
of which patients received the actual treatment and which received the sham. 
Participant timeline and Procedures:  
 
Time 
Visit  
Procedure 
Week 0 
Screening and enrollment  
Eligibility screening, Inform consent, General advice for 
PFMT  

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Baseline assessment  
Demographic data, Questionnaires (VLQ, FSFI, FGSIS, ICIQ-
VS) 
Physical examination 
 
3D endovaginal US  
PV: Evaluate genital hiatus (Gh), vaginal caliber 
(fingerbreadth) 
Evaluate baseline vaginal thickness  
Week 1 
Intervention * 
Radiofrequency therapy Vs Sham  
72 hours 
Post-
intervention 
Telemedicine  
Inquire with the patients about any adverse events they 
may have experienced following the intervention 
Week 4 
(1 month 
Post-
intervention) 
Telemedicine/questionnaires 
by mail 
Questionnaires (VLQ, FSFI, FGSIS, ICIQ-VS), 
Assessment for any adverse events 
The Patient Global Impression of Improvement (PGI-I) 
 
Week 13 
(3 months 
Post-
intervention) 
 
Follow-up visit 
Questionnaires (VLQ, FSFI, FGSIS, ICIQ-VS) 
Assessment for any adverse events 
The Patient Global Impression of Improvement (PGI-I) 
Physical examination 
 
3D endovaginal US 
PV: Evaluate genital hiatus (Gh), vaginal caliber 
(fingerbreadth) 
Evaluate vaginal thickness post-RF treatment  
Outcomes/endpoints: 
Primary outcomes  
• Subjective outcomes 
- The Vaginal Laxity Questionnaire (VLQ) will be utilized to assess patient-reported levels of vaginal 
laxity. 
Secondary outcomes  
• Subjective outcomes 
- The Thai version of the Female Sexual Function Index (FSFI) will be administered to evaluate 
sexual function. 
- The Thai version of the Female Genital Self-Image Scale (FGSIS) will be employed to assess 
patients' perceptions of their genital self-image. 

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- The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), 
validated in Thai, will be used for symptom evaluation. 
- The Patient Global Impression of Improvement (PGI-I) will measure overall patient satisfaction with 
treatment outcomes. 
- Patients will report any side effects or adverse events experienced during the study. 
• Objective outcomes 
- Vaginal wall thickness will be assessed using 3D transvaginal ultrasound imaging, following the 
standardized protocol established in previous studies. 
Discontinuation/withdrawal criteria: 
- Adverse Events: Development of serious adverse effects or complications related to the therapy, 
such as severe pain, infection, or significant bleeding. Or any signs or concerns that the participant 
might not be safe to continue, as determined by the investigator. 
- Pregnancy: If a participant becomes pregnant during the study, they may need to withdraw to 
ensure safety for both the mother and the fetus. 
- Medical Conditions: Emergence of new medical conditions or exacerbation of existing conditions 
that could complicate participation or the study's objectives such as active genital infection. 
- Patient Preference: Participant's decision to withdraw from the study for personal reasons, 
including dissatisfaction with the treatment or its effects. 
Adverse Event Reporting:  
- Pain, discomfort, or a burning sensation during or after the procedure. 
- Worsening of urinary symptoms 
- The presence of vaginal burn 
- Vaginal discharge 
- The presence of abnormal vaginal bleeding (spotting).  
- Swelling and bruising: Mild to moderate swelling and bruising at the treatment site  
- Infection: There is a small risk of infection at the site of microneedling if proper post-treatment 
care is not followed. 
Statistical Analysis Plan:  

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- Software: Stata version 14 for sample size calculation and statistical data analysis. 
- Data analysis: calculate relevant statistics to summarize range, means, medians, and variability of 
numerical data, 95% confidence intervals for means, geometric means, and proportions 
- Comparative Analysis: use t-tests and chi-square tests to evaluate statistical significance of 
differences in means (possibly log-transformed) or proportions 
- Use Intention to treat for data analysis  
Sample size determination:  
- Calculate with “Two independent population proportions formula (without continuity correction)” 
Proportion in group1 (Treatment group) (p1) = 0.5* 
Proportion in group2 (Sham group) (p2) = 0.12** 
alpha(α) = 0.05, Beta(β) = 0.2 
*Sample size (N) = 23 / groups 
Add dropout 20% = 28 / groups 
                                                           Total sample size (N) = 56 participants 
- Proportion in group1 (Treatment group) (p1) = 0.5 >> Predicted % improvement in treatment 
group (Fractional bipolar radiofrequency) = 50% 
- Proportion in group2 (Sham group) (p1) = 0.12 >> % improvement in sham group (base on VLQ) = 
12% (Wattanakrai, P, et al., 2022) 
Recruitment procedure: 
1. Collaboration with Healthcare Providers: 
- 
Pre-menopausal women with complaints of vaginal laxity or vaginal looseness will be recruited 
from the outpatient department—FPMRS clinic at Ramathibodi Hospital 
- 
Collaborate with obstetrician, gynecologists, or primary care providers who may refer eligible 
patients to the study. Provide them with study materials they can share with potential 
participants. 

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2. Advertising: 
- 
Poster and Brochures: Distribute in relevant clinics in the hospital. 
Informed Consent Process:  
- 
Preparation of Informed Consent Document: The study’s purpose, objectives, and significance, a 
clear explanation of the procedures involved, including the randomization process and treatment 
assignments, potential risks and benefits of participation, the confidentiality and security measures 
for managing personal data, information about the right to withdraw from the study at any time 
without penalty. >> By principal investigator  
- 
In-Person Discussion:  when the patient feels interested, a member of the research team will 
schedule a one-on-one meeting to explain the study verbally. This meeting will allow participants 
to ask questions and clarify any concerns. 
- 
Assessment of Understanding: The research team will assess participants' comprehension of the 
information presented by asking follow-up questions to ensure they fully understood the study 
and their rights as participants. 
- 
Voluntary Participation Assurance: Emphasize that participation in the study is entirely voluntary 
and that individuals can withdraw at any time without affecting their future care or treatment. 
- 
Obtaining Written Consent: After ensuring that potential participants have all their questions 
answered and understand the study, they will be provided with the informed consent document 
to review and sign. The principal investigator or a designated team member will also sign the 
document to confirm that the informed consent process was appropriately conducted. 
- 
Documenting Consent: Copies of the signed informed consent documents will be securely stored 
and participants will receive their own copy for reference. 
Privacy and confidentiality (Data Management Plan): 
1. The researcher and their collaborators are responsible for data management and ensuring patient 
confidentiality. 
2. Each participant will be assigned an ID to anonymize data and samples; identifiable information 
like hospital numbers or names will be documented in a codebook maintained exclusively by the 
lead researcher. 
3. Physical copies of data (such as paper forms and consent documents) will be securely stored in 
locked cabinets, with access restricted to authorized individuals. 

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4. All electronic data will be maintained in encrypted databases, and data transfers will occur over 
secure, encrypted networks. Regular backups will be executed to prevent data loss, and data will 
be retained for a minimum of five years. 
 
Ethical consideration: 
- Risks to participants and how to minimize the risks: 
There are no significant physical or mental risks associated with the study, as the Morpheus8V 
device is specifically designed for vaginal treatments and the research protocol adheres to 
established treatment standards. Additionally, participants have voluntarily consented to take 
part in the study. 
- Direct Benefits to Participants  
Participants in the treatment group will receive this energy-based therapy (fractional bipolar 
radiofrequency) for vaginal laxity at no cost. Meanwhile, participants in the sham group will have 
the opportunity to receive the same therapy after the study concludes without cost, if the 
research demonstrates its efficacy in treating vaginal laxity. 
- Scientific or social value 
The value of this research is to provide valuable insights for medical professionals regarding the 
efficacy and safety of fractional bipolar radiofrequency therapy in treating vaginal laxity. The 
study seeks to introduce this new non-surgical modality as a potential treatment option for 
premenopausal women experiencing vaginal laxity. Additionally, it aims to provide evidence of 
histological changes or improvements resulting from fractional bipolar radiofrequency treatment, 
thereby enhancing the understanding of its therapeutic effects. 
- Justification if enrolling potentially vulnerable subjects. 
The study will not involve individuals from vulnerable populations. 
- Travel compensation and compensation for injury  

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Participants will receive a travel compensation of 400 baht for each treatment and follow-up 
visit, including the final visit for the sham group to receive treatment after three months of the 
study.  
- Plan of board consent 
None  
Study Timeline: 
Activities  
 
2024 
2025 
8 9 10 11 12 1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
41.Literature review and 
proposal preparation  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. Proposal submission 
and approval  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. Data collection and 
analysis  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.Manuscript writing and 
submission  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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References: 
1.Al-Mousa N, Al-Badr A, Al-Tannir (2022) Vaginal Laxity: Prevalence, Risk Factors, Diagnostic and Therapeutic 
Approaches. Gynecol Obstet Open Acc 6: 147. DOI: 10.29011/2577-2236.100147 
2.Rogers RG, Pauls RN, Thakar R, et al. An International Urogynecological Association (IUGA)/International 
Continence Society (ICS) joint report on the terminology for the assessment of sexual health of women 
with pelvic floor dysfunction. Neurourol Urodyn. 2018;37(4):1220-1240. doi:10.1002/nau.23508 
3.Krychman ML. Vaginal Laxity Issues, Answers and Implications for Female Sexual Function. J Sex Med. 
2016;13(10):1445-1447. doi:10.1016/j.jsxm.2016.07.016 
4.Dayan E. Noninvasive Vulvar and Intravaginal Treatments. Clin Plast Surg. 2022;49(4):505-508. 
doi:10.1016/j.cps.2022.07.004 
5.Polland A, Duong V, Furuya R, et al. Description of Vaginal Laxity and Prolapse and Correlation With 
Sexual Function (DeVeLoPS). Sex Med. 2021;9(6):100443. doi:10.1016/j.esxm.2021.100443 
6.The Basic Science of Radiofrequency-Based Devices dol:http://dx.doi.org/10.5772/intechopen.96652 
7.Blusewicz TA, Coley KP, Moore RD, Miklos JR. The Novel Use of Bipolar Radiofrequency Microneedling in 
the Treatment of Lichen Sclerosus. Surg Technol Int. Published online December 1, 2023. 
doi:10.52198/23.STI.43.GY1743 
8. Wattanakrai P, Limpjaroenviriyakul N, Thongtan D, Wattanayingcharoenchai R, Manonai J. The efficacy and 
safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the 
treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial. Lasers Med Sci. 
2022;37(3):1829-1842. doi:10.1007/s10103-021-03438-3 
9.Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal 
delivery: nonsurgical vaginal tightening. J Sex Med. 2010;7(9):3088-3095. doi:10.1111/j.1743-
6109.2010.01910.x 
10.Abdelaziz A, Blusewicz TA, Coley KP, Karram M. Safety, tolerability and short-term efficacy of 
transvaginal fractional bipolar radiofrequency therapy for symptoms of stress and or mixed incontinence in 

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conjunction with genitourinary syndrome of menopause. Neurourol Urodyn. 2023;42(4):807-813. 
doi:10.1002/nau.25170 
11.Alcazar JL, Para E, Tomaizhe A, Laza MV, Guerriero S. Vaginal wall thickness as potential biomarker of 
vaginal health. A proposal for standardized ultrasound measurement using three-dimensional transvaginal 
ultrasound. J Clin Ultrasound. 2023;51(8):1366-1369. doi:10.1002/jcu.23547 
12.QUICK REFERENCE GUIDE (QRG) Morpheus8V Date: November 2021 
13. Dayan E, Chia C, Burns AJ, Theodorou S. Adjustable Depth Fractional Radiofrequency Combined With 
Bipolar Radiofrequency: A Minimally Invasive Combination Treatment for Skin Laxity. Aesthet Surg J. 2019 
Apr 8;39(Suppl_3):S112-S119. doi: 10.1093/asj/sjz055. PMID: 30958550; PMCID: PMC6460431.