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Background: Despite several treatments that have been used for women reporting vaginal laxity (VL), to our knowledge no systematic review is available on the topic so far. Aim: In this study, we sought to summarize the best available evidence about the efficacy and safety of interventions for treating VL, whether conservative or surgical. Methods: A comprehensive search strategy was performed in Medline, Embase, Scopus, Web of Science, and Cochrane Library for reports of clinical trials published from database inception to September 2022. Studies selected for inclusion were in the English language and were performed to investigate any type of treatment for VL, with or without a comparator, whether nonrandomized studies or randomized controlled trials (RCTs). Case reports and studies without a clear definition of VL were excluded. Outcomes: The outcomes were interventions (laser, radiofrequency, surgery, and topical treatment), adverse effects, sexual function, pelvic floor muscle (PFM) strength, and improvement of VL by the VL questionnaire (VLQ). Results: From 816 records, 38 studies remained in the final analysis. Laser and radiofrequency (RF) were the energy-based treatment devices most frequently studied. Pooled data from eight observational studies have shown improved sexual function assessed by a Female Sexual Function Index score mean difference (MD) of 6.51 (95% CI, 5.61-7.42; i2 = 85%, P < .01) before and after intervention, whether by RF (MD, 6.00; 95% CI, 4.26-7.73; i2 = 80%; P < .001) or laser (MD, 6.83; 95% CI, 5.01-8.65; i2 = 92%; P < .01). However, this finding was not shown when only 3 RCTs were included, even when separated by type of intervention (RF or laser). When RF treatment was compared to sham controls, VLQ scores did not improve (MD, 1.01; 95% CI, −0.38 to 2.40; i2 = 94%; P < .001). Patient PFM strength improved after interventions were performed (MD, 4.22; 95% CI, 1.02-7.42; i2 = 77%; P < .001). The ROBINS-I (Risk Of Bias In Nonrandomized Studies of Interventions) tool classified all non-RCTs at serious risk of bias, except for 1 study, and the risk of bias—1 analysis found a low and unclear risk of bias for all RCTs. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) certainty of the evidence was moderate for sexual function and the VLQ questionnaire and low for PFM strength. Clinical Implications: Sexual function in women with VL who underwent RF and laser treatment improved in observational studies but not in RCTs. Improvement in PFM strength was observed in women with VL after the intervention. Strengths and Limitations: Crucial issues were raised for the understanding of VL, such as lack of standardization of the definition and for the development of future prospective studies. A limitation of the study was that the heterogeneity of the interventions and different follow-up periods did not make it possible to pool all available data. Conclusions: Vaginal tightening did not improve sensation in women with VL after intervention, whereas RF and laser improved sexual function in women with VL according to data from observational studies, but not from RCTs. PFM strength was improved after intervention in women with VL. [ABSTRACT FROM AUTHOR]

Introduction: Vaginal laxity is a widespread and undertreated medical condition associated especially with vaginal parity. Aim: To evaluate the efficacy and safety of electroporation therapy treatment of vulvovaginal laxity by the Jett Plasma for Her II device. Methods: The Jett Plasma for Her II Study is a multicentric, prospective, randomized, single-blinded, and controlled study. Women presenting with vaginal laxity were randomized to receive electroporation therapy delivered to the vaginal tissue (active—82 patients) vs. therapy with zero intensity (placebo—9 patients). Results: A total of 91 subjects whose average age was 48.69 ± 10.89 were included. Due to the results of a one-way analysis of variance, it may be concluded that in the case of the vaginal laxity questionnaire (VLQ), there is a statistically significant difference between actively treated patients and the placebo group (F1,574 = 46.91; p < 0.001). In the case of the female sexual function index (FSFI), a one-way ANOVA test also showed a statistically significant difference between the actively treated patients and the placebo group (F1,278 = 7.97; p = 0.005). In the case of the incontinence impact questionnaire-7 (IIQ-7), a one-way ANOVA test showed a statistically significant difference between the actively treated patients and the placebo group (F1,384 = 15.51; p < 0.001). It confirms that improvement of vaginal laxity is conjoined with benefits in symptoms of urinary incontinence. Biopsy performed after the end of the treatment shows an increase in the vaginal mucosa thickness by an average of 100.04% in the active group. The treatment was well tolerated with no adverse events. No topical anesthetics were required. Conclusions: Treatments of vulvovaginal laxity by electroporation therapy achieved significant and sustainable 12-month effectiveness. Responses to the questionnaires also suggest subjective improvement in self-reported sexual function, incontinence, sexual satisfaction, and urogenital distress. [ABSTRACT FROM AUTHOR]

Abstract Objective Vaginal laxity could negatively influence women’s sexual function. This study aimed to explore the efficacy and safety of temperature controlled dual-mode (monopolar and bipolar) radiofrequency (RF) in women with vaginal laxity. Methods A total of 102 patients with vaginal laxity were treated with temperature-controlled RF. The present study implemented Vaginal Laxity Questionnaire (VLQ), Female Sexual Function Index (FSFI) questionnaire and Sexual Satisfaction Questionnaire (SSQ) on all patients at baseline and after treatment. Pelvic Organ Prolapse Quantification System (POP-Q) system was applied to physical examination, and vaginal manometer to examine the strength of voluntary contractions of the pelvic floor muscles. Results The VLQ score was gradually increased after RF treatment at 1, 3, 6 and 12 months, accompanying by the significant improvement in total FSFI scores and the six domains (sexual desire, sexual arousal, lubrication, orgasm, satisfaction, pain). The increased sexual satisfaction based on the SSQ score was found after temperature-controlled RF. The result of POP-Q stage showed significant difference in women after treatment, with the women having Stage I of 45.10% at baseline, 36.27% at 1 month, 28.43% at 3 months, 19.61% at 6 months and 10.78% at 12 months. The mean pressure and mean duration of pelvic contractions were increased gradually at the 1-, 3-, 6- and 12- month follow-up. Conclusion Temperature controlled dual-mode (monopolar and bipolar) radiofrequency may be associated with improvement of vaginal laxity, and contribute to enhancement to female sexual function and pelvic floor muscles.

After vaginal delivery and improper episiotomy suturing about 40% of women complaint from wide vagina and defect in pelvic support which will lead to loss of satisfaction in sexual relationship with the partner. In recent years many different methods were used for solve the complaint for many of these ladies of wide vagina and loss of satisfaction in their sexual relationship, which was either surgical or non-surgical ways. The objective: to confirm that the fractional CO2 laser was emergency noninvasive modalities to solve problem with or without simple perineoplasty could be needed to restore pelvic support and improve sexual function of women. Materials and methods: 101 women took part in this prospective study. All women were old from 22 to 45 years. The degree of vaginal laxity severity was evaluated by vaginal examination in each patient. Perineal length, vaginal orifice length were measured and female sexual function index questionnaire was used to assess sexual satisfaction score. The women had different degree of vaginal laxity and underwent fractional CO2 laser from 2 to 3 sessions with or without simple perineoplasty and follow up them for gain vaginal tightness and improvement of their sexual function. Results. There was significant correlation between increase body mass index and parity with decrease sexual function of the women as the P values equal to 0.0001 and 0.029 consequently. Regarding the anatomical variation of the genital tract that occurs to women before and after doing the laser sessions and simple perineoplasty, our study show very significant correlation between partner satisfaction and anatomical variation were P value equal the following consequently 0.003, 0.035 and 0.57. Conclusion. The degree of vaginal laxity should be clinically evaluated and accordingly the use of only fractional CO2 laser with or without simple surgical perineoplasty to achieve vaginal tightness and improve in sexual function. [ABSTRACT FROM AUTHOR]

Background: Vaginal laxity (VL) is characterized by the relaxing of the vaginal wall that affects the quality of life and sexual function of patients. The current management of VL such as Kegel exercises and topical or systemic hormonal replacement results in unsatisfactory outcomes; thus, novel modalities are needed to improve the efficacy. Vaginal fractional carbon dioxide (CO2) laser treatment has shown growing applications for the treatment of VL, but results show nonconformities due to the lack of objective evaluations. In this study, we aimed to validate the clinical efficacy and biophysical benefits of fractional CO2 laser treatment for VL patients with the incorporation of objective approaches. Methods: This is a descriptive study without controls. A total of 29 patients were enrolled and treated with two sessions of FemTouch vaginal fractional CO2 laser, with a one-month interval between sessions. Both subjective and objective measurements, including female sexual function index (FSFI), vaginal health index score (VHIS), vaginal tactile imaging (VTI), and histology were used to validate the clinical efficacy and biophysical benefits after treatment. Results: The overall FSFI scores and VHIS scores after the first and second treatment sessions were significantly higher than the baseline scores (p < 0.01, n = 29). VTI measurements showed a significant increase in maximal pressure resistance (kPa) of both the anterior and posterior vaginal walls at a 10–12-month post-treatment visit compared with pre-treatment controls (p < 0.001; n = 16). Histological examination showed that laser treatment led to increases in the thickness of the stratified squamous epithelium layer and density of connective tissues in the lamina propria. Conclusions: Fractional CO2 vaginal laser treatment can improve both vaginal health and sexual function and restore vaginal biomechanical properties by increasing vaginal tissue tightening and improving vaginal tissue integrity in Asian women. Our data support that fractional CO2 vaginal laser is a valid treatment modality for VL. [ABSTRACT FROM AUTHOR]

Non-invasive vaginal rejuvenation with radiofrequency (RF) and lasers devices have gained popularity, but well-designed studies confirming their effectiveness are lacking. The aim of this study was to compare the efficacy and safety of a multipolar RF and pulsed electromagnetic field-based device (PEMF) versus sham for vaginal laxity. Thirty-two premenopausal females with ≥ 1 vaginal delivery and self-reported vaginal laxity were randomized into 2 groups: active (RF + PEMF) and sham. Both groups received 3 vaginal treatments at 3-week interval. The Vaginal Laxity Questionnaire (VLQ), perineometer measurements, and Brink score were conducted at baseline, 4, and 12 weeks after treatments. Pre and post-treatment vaginal histology, Female Sexual Function Index (FSFI), subjects' satisfaction, pain, and adverse events were assessed. The active group VLQ scores increased and were significantly better than the sham group (p < 0.001). At the final follow-up, 50% of the active group reported no vaginal laxity (VLQ > 4) versus 12% in the sham group (p = 0.054). In the active group, all domains of perineometer measurements and Brink scores (p < 0.001), FSFI scores (p < 0.05), and patients' satisfaction (p < 0.001) were significantly increased and higher in the active group. Mild adverse effects including pain and burning sensation were not different between groups except for itch which was significantly higher in the sham arm (p = 0.014). Histology after RF + PEMF treatments demonstrated neocollagenesis, neoelastogenesis, and neoangiogenesis. In conclusion, combination RF + PEMF therapy was safe, improved vaginal laxity, strengthened pelvic floor muscles, and improved female sexual function for at least 12-week post-procedures with confirmed histological improvements. This study was registered on the Thai Clinical Trials Registry, TCTR20200803002 on 2020–07-30 "retrospectively registered." [ABSTRACT FROM AUTHOR]

Objective: This subanalysis of the VIVEVE I trial aimed to evaluate the impact of cryogen-cooled monopolar radiofrequency (CMRF) therapy, for the treatment of vaginal laxity, on the domains of sexual function included in the Female Sexual Function Index (FSFI). Materials and Methods: The VIVEVE I clinical trial was prospective, randomized, single-blind, and Shamcontrolled. Nine clinical study centers in Canada, Italy, Spain, and Japan were included. This subanalysis included premenopausal women with self-reported vaginal laxity who had -1 term vaginal delivery and a baseline FSFI total score <26.5, indicating sexual dysfunction. Enrolled subjects were randomized (2:1) to receive CMRF therapy [Active (90 J/cm²) vs. Sham (<1 J/cm²)] delivered to the vaginal tissue. Independent analyses were conducted for each FSFI domain to evaluate both the mean change, as well as the clinically important change for Active- versus Sham-treated subjects at 6 months post-intervention. Results: Subjects randomized to Active treatment (n = 73) had greater improvement than Sham subjects (n = 35) on all FSFI domains of sexual function at 6 months postintervention. The analysis of covariance change from baseline analyses showed statistically significant improvements, in favor of Active treatment, for sexual arousal ( p = 0.004), lubrication ( p = 0.04), and orgasm ( p = 0.007). In addition, Active treatment was associated with clinically important and statistically significant improvements in sexual desire [Odds ratio (OR) = 3.01 (1.11- 8.17)], arousal [OR = 2.73 (1.06-7.04)], and orgasm [OR = 2.58 (1.08-6.18)]. Conclusions: This subanalysis showed CMRF therapy is associated with statistically significant and clinically important improvements in sexual function in women with vaginal laxity. These findings provide the first randomized, placebo-controlled energy-based device evidence for functional improvements associated with a nonsurgical modality for a highly prevalent and undertreated condition. [ABSTRACT FROM AUTHOR]

Introduction Vaginal laxity is a highly prevalent and undertreated medical condition. Aim To evaluate the efficacy and safety of surface-cooled, monopolar radiofrequency (RFc) therapy for the treatment of vaginal laxity in the VIVEVE I trial. Methods The VIVEVE I trial was a prospective, randomized, single-blinded, and sham-controlled study. Nine study centers in Canada, Italy, Spain, and Japan participated. Women presenting with vaginal laxity were screened and informed consent was obtained. Major study inclusion criteria were premenopausal status, age at least 18 years, at least one full-term vaginal delivery, and normal genito-pelvic examination results. Enrolled subjects were randomized (2:1) to receive RFc therapy (Active [90 J/cm 2 ] vs Sham [1 J/cm 2 ], respectively) delivered to the vaginal tissue. Main Outcome Measures The primary efficacy outcome was the proportion of randomized subjects reporting “no vaginal laxity” (Active vs Sham) at 6 months postintervention, which was assessed using the Vaginal Laxity Questionnaire. Treatment-emergent adverse events were evaluated in all treated subjects. Secondary efficacy end points included change on the Female Sexual Function Index (FSFI) and the revised Female Sexual Distress Scale (FSDS-R). Results No vaginal laxity was achieved by 43.5% and 19.6% ( P = .002) in the Active and Sham groups, respectively. Differences in FSFI and FSDS-R total scores (Active vs Sham) were 1.8 ( P = .031) and −2.42 ( P = .056), respectively, in favor of Active treatment. Treatment-emergent adverse events were reported by 11.1% and 12.3% of subjects in the Active and Sham arms, respectively. Conclusion The VIVEVE I trial is the first randomized, controlled, blinded, clinical study of RFc for the treatment of vaginal laxity. A single treatment of RFc therapy was found to be safe and associated with both improved vaginal laxity and improved sexual function. The results from this trial support the use of a novel non-surgical therapy for vaginal laxity, a prevalent and undertreated condition. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Our goal was to assess how physician members of the International Urogynecological Association (IUGA) perceive and manage vaginal laxity. Methods: An Internet-based survey was circulated targeting physician members of IUGA that consisted of 27 questions and was designed to query attitudes and practices with respect to vaginal laxity. Results: Five hundred and sixty-three of the 2,235 surveys were completed (25 % response rate). Most respondents (65 % male and 35 % female) listed urogynecology as their specialty. The geographical distribution was Europe (39 %), North America (23 %), Asia (15 %), South America (14 %), Australia (6 %), and Africa (3 %). Eighty-three percent described laxity as underreported by their patients. The majority considered laxity a bothersome condition to patients that impacts relationship happiness and sexual function. The introitus was listed most often as being responsible for these symptoms. Whereas only 54 % offered surgical treatment, surgery was cited as more effective than Kegel exercises or physical therapy. North Americans were more likely to prefer and perform surgical treatment for this problem. Conclusion: Vaginal laxity is common and may impact sexual function and quality of life. Expanding our knowledge regarding pathophysiology and treatment would be of benefit to these patients. [ABSTRACT FROM AUTHOR]

Introduction. Aesthetic gynecology is undoubtedly a fast-growing subspecialty with increasing demand for a variety of procedures to beautify the female genitals. It would typically include procedure(s) to enhance, reduce or refashion various anatomical components of the female genitals, so as to cumulatively improve the aesthetic appearance of the female genitals. Radiofrequency energy is a form of electromagnetic current that can be delivered through various tissue types (i.e., skin, fat and muscle) to generate thermal energy. Radiofrequency (RF) was initially used in medicine in the 1920s for electrocautery. Over the past 15 years, its use in aesthetic surgery has increased. Science behind radiofrequency. In 2002, FDA approved the first monopolar RF device for facial wrinkle reduction (ThermaCool; Thermage, Inc., Hayward, California). Since 2002, more sophisticated RF devices have been developed to deliver RF energy in different manners (i.e., bipolar, multipolar and fractional) with more safety features. Unlike lasers, RF does not target specific chromophores by selective photothermolysis. Instead, RF generates heat as a result of different tissue resistance or impedance to the electromagnetic current. When RF energy is applied to the underlying skin and soft tissue, it generates contraction by two mechanisms: (1) immediate cleavage of hydrogen bonds in the collagen triple helix, causing shortening and thickening of the collagen fibrils, and (2) initiation of a wound healing cascade to trigger neoangiogenesis, neocollagenesis and elastin reorganization over the following 3-4 months. These processes along with growth factor infiltration restore the elasticity and moisture of the underlying vaginal mucosa. Heat shock protein activation and inflammation activation are also considered to be the underlying mechanisms of action. Methodology. Multiple prospective small case series studies have reported outcomes of women treated with radiofrequency system. Typically, three treatments at an interval of 4 to 6 weeks were applied. The clinical endpoint temperature had a range of 40°C to 45°C, which was maintained for 3 to 5 minutes per treated zone during 30 minutes’ total treatment time. Results. An improvement in vaginal laxity symptoms was reported in some patients after three treatments. They also reported subjective improvements in both vaginal atrophy symptoms and sexual function. No serious adverse effects were reported in these case series. In another trial, the radiofrequency device was studied in a cohort of 25 sexually active women with self-reported anorgasmia or increased latency to orgasmic response. Six patients received three treatments four weeks apart. Approximately 75% of the participants reported improved orgasmic responsivity, vaginal lubrication and clitoral sensitivity. The authors suggested sustained treatment benefits at 9 to 12 months. A confirmatory randomized, multicenter US-based trial is currently underway. At present, the VIVEVE I trial remains the only published, large-scale, randomized, sham-controlled, blinded study of a radiofrequency-based treatment. Conclusions. Radiofrequency treatments were well tolerated and were associated with improvement in vaginal health and with the amelioration of symptoms of vaginal laxity and vaginal dryness, but more studies are required for a better understanding. [ABSTRACT FROM AUTHOR]