Pelvic floor muscle training vs radiofrequency for women with vaginal laxity: randomized clinical trial.

BACKGROUND: Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. AIM: The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. METHODS: From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. OUTCOMES: The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. RESULTS: Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group. CLINICAL IMPLICATIONS: Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. STRENGTHS & LIMITATIONS: The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. CONCLUSION: After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment.

Associated factors of vaginal laxity and female sexual function: a cross-sectional study.

BACKGROUND: Female sexual dysfunction (FSD), including vaginal laxity (VL), can lead to a decrease in quality of life and affect partner relationships. AIM: We aimed to investigate the associated factors of VL and FSD and their relationship with other pelvic floor disorders in a female population. METHODS: This cross-sectional study was conducted at Chelsea and Westminster Hospital from July to December 2022. All women referred to clinical care at the urogynecology clinic were included. Participants were assessed according to sociodemographic and clinical aspects, the Pelvic Organ Prolapse Quantification system, sexual function, VL, sexual attitudes, sexual distress, sexual quality of life, vaginal symptoms, and pelvic floor disorders. Unadjusted and adjusted associated factors of VL and FSD were analyzed. OUTCOMES: The primary outcome was the identification of the associated factors of VL and FSD in a female population, and secondary outcomes included the association between VL and pelvic organ prolapse (POP) with the questionnaire scores. RESULTS: Among participants (N = 300), vaginal delivery, multiparity, perineal laceration, menopause, and gel hormone were significantly more frequent in those reporting VL (all P < .05). When compared with nulliparity, primiparity and multiparity increased the odds of VL by approximately 4 and 12 times, respectively (unadjusted odds ratio [OR], 4.26 [95% CI, 2.05-8.85]; OR, 12.77 [95% CI, 6.53-24.96]). Menopause and perineal laceration increased the odds of VL by 4 and 6 times (unadjusted OR, 4.65 [95% CI, 2.73-7.93]; OR, 6.13 [95% CI, 3.58-10.49]). In multivariate analysis, menopause, primiparity, multiparity, and POP remained associated with VL. CLINICAL IMPLICATIONS: Parity, as an obstetric factor, and menopause and staging of POP, as clinical factors, were associated with VL. STRENGTHS AND LIMITATIONS: The investigation of associated factors for VL will contribute to the understanding of its pathophysiology. The study design makes it impossible to carry out causal inference. CONCLUSION: Menopause, primiparity, multiparity, and POP were highly associated with VL complaints in multivariate analysis.

Treatment of women with vaginal laxity: systematic review with meta-analysis.

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.

Efficacy and safety of a device that combines multipolar radiofrequency with pulsed electromagnetic field for the treatment of vulvovaginal atrophy: a randomized, sham-controlled trial.

BACKGROUND: Vulvovaginal atrophy (VVA) negatively affects the sexual well-being and quality of life of postmenopausal women, yet it is underreported and undertreated. AIM: The study sought to investigate the efficacy and safety of a nonablative, noncoagulative multipolar radiofrequency (RF) and pulsed electromagnetic field-based device (PEMF) in treatment of symptoms related to VVA. METHODS: Seventy-six women ≥19 years of age with symptoms associated with VVA were enrolled into this prospective, randomized, sham-controlled, multicenter clinical study. Subjects were randomized to receive 3 RF + PEMF treatments (active group) or sham treatments (sham group) delivered to vaginal tissue at monthly intervals. The Vaginal Health Index (VHI), along with the Female Sexual Function Index (FSFI), subject sexual satisfaction and vaginal laxity (VL) score, treatment-associated pain, and adverse events were assessed at 4 follow-up (FU) visits between 1 and 12 months after treatment. OUTCOMES: Changes from baseline VHI, pH, FSFI, VL, and sexual satisfaction scores between the active and sham groups were compared before and after treatment. RESULTS: Mean VHI scores in the active group were significantly better compared with the sham group after treatment at all but the last FU visit (P < .001). A greater decrease in pH (active over sham) was seen at 1 and 4 months after treatment (P < .05). FSFI improvement was shown in the active group; however, it was not significantly better than sham improvement at all FU visits. Subject sexual satisfaction in the active group showed better improvement over sham at all FU visits (P < .05), while VL evaluations saw greater improvement in the active group at 4, 6, and 12 months posttreatment (P < .05). Treatment satisfaction was greater in the active group and pain was minimal in both groups. No serious adverse effects were reported. CLINICAL IMPLICATIONS: As a noninvasive alternative to traditional surgical and topical procedures, 3 sessions of noninvasive combination RF/PEMF safely demonstrated improvement in symptoms related to VVA. STRENGTHS AND LIMITATIONS: This study was strengthened by the randomized, sham-controlled design; large sample size; and extended FU period. The study assessments were decreased at later FU visits due to the global COVID pandemic, and this was a key limitation to the study. CONCLUSION: Nonablative, noncoagulative multipolar RF/PEMF therapy was safe, improved symptoms associated with VVA, and improved female sexual function while yielding high subject satisfaction.

Is Vaginal Laxity Associated with Vaginal Parity and Mode of Delivery?

INTRODUCTION AND HYPOTHESIS: Vaginal laxity (VL) is a common symptom of pelvic floor dysfunction. Although VL has become a frequent topic for research in the last decade, its pathogenesis is still not well understood. The objective was to determine whether vaginal parity or mode of delivery is associated with vaginal laxity. METHODS: This was a retrospective observational study involving women seen in a tertiary urogynecology clinic between May 2016 and November 2018 with symptoms of pelvic floor dysfunction. Patients underwent a standardized interview, clinical examination (POP-Q), and four-dimensional (4D) pelvic floor ultrasound (PFUS). Data regarding vaginal parity and the mode of delivery were based on patient-reported information. Archived 4D-PFUS volumes were analyzed offline to evaluate levator hiatal area on Valsalva. RESULTS: Data from 1,051 patients were analyzed. VL was reported by 236 women (23%) who were younger on average (mean age 54 vs 59 years, p < 0.001) and less likely to be menopausal (530 out of 815 [65.0%] vs.129 out of 236 [54.7%]), p = 0.004]. Symptoms of prolapse were much more common in the VL group (214 out of 236 [91%] vs 316 out of 815 [39%], p = < 0.001) and on imaging mean levator hiatal area (HA) on Valsalva was larger (31 vs 26 cm2, p = 0.01). Vaginal parity was associated with VL symptoms (235 out of 236 [99%] vs 767 out of 815 [94%], p = 0.008), but neither VL prevalence nor bother increased with higher parity. Women who delivered vaginally were three times more likely to complain of VL than those who delivered only by cesarean section. CONCLUSIONS: Vaginal laxity was found to be more prevalent in vaginally parous women. This effect seems to be largely attributable to the first delivery. Instrumental delivery was not shown to increase association with VL compared with normal vaginal delivery.

Experiences of women with symptoms of vaginal laxity - a qualitative study.

BACKGROUND: Vaginal laxity (VL) is rarely discussed among patients and their physicians possibly due to the lack of evidence-based treatments, embarrassment, and lack of knowledge in recognizing this condition. We aimed to understand the meanings that women attribute to the sensation of VL. METHODS: This is a qualitative study using in-depth interviews and thematic analysis. Sixteen participants were intentionally selected from February 2020 to December 2021. One researcher interviewed each participant in a private room guaranteeing that rapport was established. Two independent researchers performed a complete transcript of each interview immediately after its end. The sample size was achieved according to the Information Power analysis. We followed the thematic analysis proposed by Braun and Clarke. RESULTS: Of 16 patients, only one did not undergo delivery. Her complaint was not different from the rest of the group. Five major themes and subthemes were identified: the long and lonely pathway: from the identification of symptoms of VL to diagnosis (from the invisibility of VL to the perception of their symptoms; "everything will fall out!":shame, guilt and stigma as diagnosis barriers and "but I had no idea of looking for a treatment." Women's strategies to begin a help-seeking process), "the label of vaginal laxity is a heavy burden to bear" meanings associated with VL complaints, effect of VL on sexual intercourse and "I know it changed everything!" relationship with the partner. CONCLUSION: VL is a symptom that is still little understood by women, and little explored by health professionals, with repercussions on personal and marital life.

The 50 most cited articles and science mapping analysis of vaginal tightening.

INTRODUCTION AND HYPOTHESIS: The study was aimed at exploring the 50 most cited articles related to vaginal tightening. METHODS: The papers were searched through the Thomson Reuters Web of Science on 30 July 2022, and were ranked by the total number of citations. The included articles were analyzed for author, journal, country, number of citations, keywords, subject matter, and level of evidence. The search output was also imported into VOSviewer. RESULTS: The 50 most cited articles were cited a combined total of 2,558 times. The papers were published between 1990 and 2020, of which 86% were published between 2010 and 2020. They included 38 original articles, 8 reviews, 3 editorial articles, and 1 letter. Most articles were published in gynecology-related journals (n=30, 60%). The articles covered a wide range of topics, the most common being laser/radiofrequency treatment, vaginal tightening procedures, and urinary incontinence. The majority presented findings supported by level IV or V evidence. Through co-occurrence analysis, high-frequency words and countries were displayed well. CONCLUSIONS: The study shed light on frequently read articles and influential topics about vaginal tightening. The highly cited literature mainly focused on laser or radiofrequency treatments and gynecologists currently dominate the highly cited literature on vaginal tightening. The articles related to surgical treatments are low in number and evidence level so far. The co-occurrence analysis reveals the hot research content and active countries in the field. In general, the study provides useful evidence for future research and educational materials.

The efficacy and safety of temperature controlled dual-mode radiofrequency in women with vaginal laxity.

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.

Functional and sexual outcomes following surgical vaginal introital reduction.

OBJECTIVE: Surgical introital reduction procedures are commonly performed for the treatment of vaginal laxity (VL), yet poorly studied. The aim of this study was to assess clinical outcomes following surgical vaginal introital reduction for VL. METHODS: This was an ambidirectional cohort study conducted in a single urogynecology center. All sexually active women who had vaginal introital surgical reduction for VL between March 2015 and September 2020 were included in this study. VL was defined as a genital hiatus distance ≥4cm according to the POP-Q classification, associated with symptoms of laxity. The primary endpoint was sexual health assessed by the Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ), while the secondary endpoints included postoperative pain, perioperative complications, rate of dyspareunia, patient satisfaction and success rate based on the Patient Global Improvement Index (PGI-I) and Vaginal Laxity Questionnaire (VLQ). RESULTS: Of the 27 patients sent the questionnaires, 23 sexually active patients returned the completed ones and were included in the study. Participants had a mean age and BMI of 41 years (range 24-74) and 21.3 (range 17.6-31.9) respectively. The most prevalent preoperative symptom was feeling of VL in 82.6% followed by bulging sensation in 47.8%. Preoperative dyspareunia was reported in 8/23 (34.8%). Surgical interventions involved perineorrhaphy with (n=14) or without (n=9) levator ani plication. The PPSSQ mean sexual health score was 86.7/100 (SD 5.8; range 16.7-93.3) and the mean discomfort and pain score was 27.5/100 (SD 26.0; range 0-80). Postoperative sexuality was reported to better, identical or worse in 16 (69.6%), 2 (8.7%) and 5 (21.7%) patients respectively. On PGI-I, patients reported feeling much better, better, slightly better and no change in 10 (43.5%), 5 (21.7%), 5 (21.7%) and 3 (13.0%) respectively. None of the women reported feeling worse. The overall post-operative complication rate was 3/23 (13.0%), including a perineal hematoma, and two cases of reoperation for narrow introitus. De novo dyspareunia was reported by 11/18 (61.1%) patients, occurring often or more in 4/18 (22.2%) patients, due to narrow introitus (n=2), enlarge introitus (n=1) and vaginal dryness (n=1). CONCLUSION: Vaginal introital reduction surgery is a viable treatment option for symptoms of vaginal laxity after failure of conservative measures. However, patients should be made aware of the risk of de novo dyspareunia.

Measurement of the vaginal wall thickness by transabdominal and transvaginal ultrasound of women with vaginal laxity: a cross-sectional study.

INTRODUCTION AND HYPOTHESIS: An objective diagnostic method to understand vaginal laxity (VL) is still missing. The aim of our study is to determine whether vaginal wall thickness (VWT) measured by ultrasound may differ according to the abdominal or vaginal techniques and to assess whether clinical variables are associated with vaginal measurements of women with VL. METHODS: A cross-sectional study conducted at a tertiary hospital included 82 women aged ≥ 18 years with VL complaints assessed by the Vaginal Laxity Questionnaire. Women who reported severe comorbidities or vulvovaginal disorders, previous treatment for VL, and use of vaginal estrogen in the last 6 months were excluded. Participants reporting VL underwent transabdominal (TAUS) and transvaginal ultrasound (TVUS) and physical examination and answered validated questionnaires. Descriptive data were given as mean and standard deviation, median (range), and absolute and relative frequency. The significance level adopted for this study was 5%. Sample size calculation was not performed for the present study. RESULTS: Mean age was 41.20 ± 8.64 years, and most participants were multiparous, with previous vaginal delivery and having vaginal intercourse. A statistically significant difference (up to 3 mm) between TAUS and TVUS measurements of the VWT was found in the proximal, middle-third, and distal compartments. A significant correlation was found between VWT and TAUS or TVUS in the mid-third and distal compartments. CONCLUSION: A significant correlation was found between the VWT measurements in TVUS and TAUS. Our findings might give the health professional more possibilities for investigating VWT according to patient characteristics.

Cross-cultural adaptation and validation of the Brazilian Portuguese version of the Female Sexual Distress Scale-Revised questionnaire for women with vaginal laxity.

INTRODUCTION AND HYPOTHESIS: Vaginal laxity (VL) can impair women´s quality of life and there are not many tools aimed at quantitatively addressing this complaint. Sexual distress can be present within this group of patients. The aim of our study is to carry out the cross-cultural adaptation/translation and validation of the Female Sexual Distress Scale-Revised (FSDS-R) for Brazilian Portuguese women with VL. METHODS: Women age ≥ 18 years, with VL (n=82), and without VL (n=53) were included. Continuous variables were described in the form of mean/standard deviation or median/range, and Student's t test was used. The Chi-squared test was used for dichotomous variables. Cronbach's alpha coefficient was used for internal consistency and Spearman's correlation was used to assess construct validity (FSDS-R, Female Sexual Function Index [FSFI], and Incontinence Questionnaire Vaginal Symptoms [ICIQ-VS]). A significance level of 5% was established using a two-tailed test. RESULTS: Women with VL presented more anal/vaginal sexual intercourse than women without VL (p=0.030). All three instruments (FSDS-R, FSFI, and ICIQ-VS) presented discriminant validity between women with and without VL (p<0.001). A high internal consistency (Cronbach´s alpha =0.887) was found in women with VL and without VL (0.917). Regarding construct validity (n=82), there was a strong positive correlation between FSDS-R score and ICIQ-VS scales, except for a weaker correlation between the ICIQ-VS vaginal symptoms subscale (r: +0.2788; p=0.013). A moderate negative correlation was found between FSDS-R and all FSFI domains (p<0.001), except for pain (p<0.062). CONCLUSIONS: The Brazilian version of the FSDS-R showed adequate internal consistency and discriminant validity, and a correlation was found with other instruments such as FSFI and ICIQ-VS.

Is vaginal laxity an early symptom of pelvic organ prolapse?

INTRODUCTION AND HYPOTHESIS: We aimed to determine whether vaginal laxity (VL) may be an early symptom of pelvic organ prolapse (POP). METHODS: This was a retrospective observational study including patients referred to a urogynecological clinic owing to symptoms of pelvic floor dysfunction. The interview included inquiry about VL and POP symptoms. Clinical examination and translabial ultrasound (TLUS) were performed to assess for POP and levator hiatal ballooning. Analysis of ultrasound datasets was performed with the reviewer blinded against all other data. Linear regression models were used to evaluate associations between age categories and symptoms. RESULTS: The analysis included 531 patients. Mean age was 59.7 years (range 17.6-92.0), mean body mass index (BMI) was 29.5 kg/m2 (14.7-53.5) and 458 (86%) were vaginally parous. Overall, POP symptoms were reported by 258 patients (49%) and VL by 118 (22%). Significant clinical POP was diagnosed in 384 patients (72%). Levator hiatal ballooning on TLUS was noticed in 56%. VL and POP symptoms showed a divergent association with age (p = 0.02). This trend remained significant after controlling for clinically significant POP (p = 0.01) and levator hiatal ballooning (p = 0.002). Of 384 women with significant objective POP, 231 (60%) reported symptoms of POP. Of 153 women with asymptomatic POP, 7 (5%) reported symptoms of VL. CONCLUSIONS: With increasing age the prevalence of VL decreases, whereas symptoms of POP increase. However, only very few women with objective POP perceive VL as their only symptom, independent of age at presentation. Therefore, vaginal laxity does not seem to be an early symptom of prolapse.

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.

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."

The efficacy of erbium-doped yttrium aluminum garnet (Er:YAG) laser in the treatment of decreased sexual sensation: a randomized, placebo-controlled trial.

Vaginal laxity, a common cause of decreased sexual sensation, is a common problem affecting the quality of life of women worldwide. Recently, lasers and energy-based devices (EBDs) have been applied in the treatment of this condition. The aim of this study was to compare the efficacy and safety of Er:YAG laser and placebo in treating decreased sexual sensation in Asians. Forty-two patients with decreased sexual sensation were randomized into 2 groups: intervention (laser treatment) and control (placebo treatment). Both groups received two treatments, at 1-month interval. Subjective and objective evaluations were done at baseline, 1-, 3-, and 6-month follow-ups. Pain score and adverse effects were also recorded. In the laser group, there was significant improvement in the patients' vaginal tightness satisfaction at 1- and 3-month follow-ups (P = 0.002 and 0.004) and also in the patients' overall satisfaction at 1- and 3-month follow-ups (P = 0.003 and 0.001). Pelvic floor muscle contraction was significantly better in the laser group after the first treatment (P = 0.043). No serious adverse effects were noted. Er:YAG laser provides improvement of sexual sensation for an average of 3 months following treatment. Mild and transient adverse effects such as leukorrhea, dryness, dysuria, vaginal itching, and spot bleeding were noted in the laser group, and these were not significantly different from the control group.

A Novel Technique Combining Human Acellular Dermal Matrix (HADM) and Enriched Platelet Therapy (EPT) for the Treatment of Vaginal Laxity: A Single-Arm, Observational Study.

BACKGROUND: There is a paucity of knowledge about cosmetic vaginal tightening procedures; therefore, the present study aimed to describe the clinical effects of a novel combination technique of human acellular dermal matrix (HADM) and enriched platelet therapy (EPT) for the treatment of vaginal laxity. METHODS: This single-arm, observational study was conducted on 52 patients with grade II to III vaginal relaxation. HADM biological band (U-shaped) was implanted in these patients by submucosal puncture in vagina under anesthesia. This was followed by thrice administration of EPT injection, once at the time surgery followed by each dose at a time interval of one month. Patients were followed up for a period of 6 months based on Female Sexual Function Index (FSFI) and Vaginal Health Index (VHI) scores. Patient satisfaction was measured using Visual Analogue Score (VAS). RESULTS: About 52 women with median age of 39 years were included in the study. The average time reported to complete HADM surgery was reported as 27 minutes. Following implantation, it was found that labia minora was significantly closed and perineal length was increased from 1.5 to 2.2 cm. Moreover, there was improvement in elasticity, contractility and lubricity of vaginal mucosa. The sexual function scores from pre- to post-surgery were significantly increased (7.95 vs. 30.09; p value: <0.001). The mean VHI score also increased significantly after 6 months of treatment (mean ± S.D. before vs after treatment: 11.2 ± 3.3 vs. 19.6 ± 4.1, P < 0.0001). The mean VAS after surgery was 1.61 ± 0.31. About 96% of the patients did not feel any pain after treatment at 6-month follow-up. No adverse effects were reported in this study. CONCLUSIONS: These findings supported that combination treatment with HADM and EPT was safe and associated with both improved vaginal laxity and sexual function. These results may provide a novel surgical technique for this prevalent and undertreated condition. LEVEL OF EVIDENCE IV: Therapeutic Study This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Efficacy and Safety of CO2 Laser Treatment for Sexual Function and Vaginal Laxity Improvement in Pre-Menopausal Women.

BACKGROUND AND OBJECTIVES: Vaginal laxity lacks standardized diagnosis and severity criteria. It is considered as a subjective complaint that reflects decreased sexual satisfaction due to vaginal loosening. Treatment modalities have included physiotherapy and plastic surgery. Recently, laser treatments have also gained popularity as a means of relieving gynecological complaints such as pelvic organ prolapse, stress urinary incontinence, and genitourinary syndrome of menopause. The aim of the current study was to evaluate the efficacy of CO2 laser treatment in women for whom a decrease in sexual sensation during intercourse and vaginal loosening were their primary complaints. STUDY DESIGN/MATERIALS AND METHODS: For this prospective study, women with reported vaginal laxity and decreased sensation during intercourse were recruited from the Sexual Dysfunction Clinic in our health care campus. Each participant received three outpatient treatments with laser therapy, according to the same protocol. Treatment efficacy was assessed by changes in the Vaginal Health Index (VHI) and Female Sexual Function Index (FSFI). RESULTS: Overall, 84 pre-menopause women, with a mean age of 47.7 years, were included in the study. Mean VHI and FSFI were increased significantly at 3 months post-treatment and decreased again at 6 months post-treatment: 11.8 ± 1.6, 13.5 ± 1.1, and 11.8 ± 1.2, respectively, P = 0.013; and 21.3 ± 1.7, 29.9 ± 1.6, and 22.5 ± 1.8, respectively, P = 0.022. The rate of sexual intercourse doubled during the period of maximal treatment effect (P < 0.0001). CONCLUSIONS: CO2 laser treatment has both a statistically and clinically significant effect on participants' complaints and sex-life, which wanes by 6 months post-treatment. Laser therapy seems to be safe in the short term, with no serious adverse events reported in the current study. Further studies are warranted to determine the long-term safety and the efficacy of maintenance laser treatments. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Vaginal laxity: which measure of levator ani distensibility is most predictive?

OBJECTIVE: To assess the predictive value of measures of levator hiatal distension at rest and on maximum Valsalva maneuver for symptoms of vaginal laxity. METHODS: This was a retrospective study of women seen at a tertiary urogynecological unit. All women underwent a standardized interview, clinical examination and four-dimensional translabial ultrasound examination. Area, anteroposterior diameter (APD) and coronal diameter (CD) of the levator hiatus were measured at rest and on maximum Valsalva maneuver in the plane of minimal hiatal dimensions using the rendered volume technique, by an operator blinded to all clinical data. The association between levator hiatal measurements and vaginal laxity was assessed, and receiver-operating-characteristics (ROC)-curve analysis was used to determine their predictive value. RESULTS: Data from 490 patients were analyzed. Mean age was 58 (range, 18-88) years, and vaginal laxity was reported by 111 (23%) women. Measurements obtained on maximum Valsalva were significantly larger in women who reported vaginal laxity than in those who did not, with mean levator hiatal area, APD and CD of 30.45 ± 8.74 cm2 , 7.24 ± 1.16 cm and 5.60 ± 0.89 cm, respectively, in the vaginal-laxity group, compared with 24.84 ± 8.63 cm2 , 6.64 ± 1.22 cm and 5.01 ± 0.97 cm in the no-laxity group (P < 0.001 for all). Measurements obtained at rest were not significantly different between the groups. Multiple logistic regression analysis controlling for age, body mass index, vaginal parity and levator avulsion confirmed these results. The best regression model for the prediction of vaginal laxity included age, vaginal parity and levator hiatal area on maximum Valsalva. ROC-curve analysis of levator hiatal measurements on maximum Valsalva in the prediction of vaginal laxity demonstrated areas under the curve of 0.68 (95% CI, 0.63-0.73) for area, 0.63 (95% CI, 0.57-0.68) for APD and 0.68 (95% CI, 0.62-0.73) for CD. CONCLUSIONS: Levator hiatal area on maximum Valsalva seems to be the measure of levator ani distensibility that is most predictive of symptoms of vaginal laxity. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Cosmetic gynecology-a systematic review and call for standardized outcome measures.

OBJECTIVE: Cosmetic gynecology, a field which has garnered substantial attention over recent years, lacks a universally accepted nomenclature. The aim of this systematic review is to evaluate techniques, outcome measures reported, and adverse events in patients undergoing cosmetic gynecology procedures and offer recommendations to improve reporting metrics. METHODS: A systematic literature search was performed using electronic databases from inception to April 2019. The search was based on 51 unique cosmetic gynecology keywords such as: "labiaplasty," "vaginal rejuvenation," and "liposuction mons pubis." All English full-text prospective and retrospective observational and interventional studies with at least five subjects that describe a cosmetic gynecology procedure were included. Only full-text articles were included. This protocol has been registered with PROSPERO (CRD 42019131860). RESULTS: A total of 1837 articles were identified from the search strategy with 42 included in the quantitative synthesis. Procedures described included: labia minora reduction with or without clitoral hood reduction, labia majora augmentation, surgical vaginal caliber reduction, mons pubis reduction/suspension, and energy-based therapy for vaginal laxity or vulvar laxity. Efficacy and satisfaction metrics were highly variable ranging from validated questionnaires to no outcome subjectively or objectively quantified. Complication rates varied by procedure but were generally low and ranged between Clavien-Dindo grades I-III. CONCLUSIONS: Although there is a breadth of literature on cosmetic gynecology surgical techniques and short-term complication rates, the terminology and outcome measures utilized are heterogeneous. To address this, standardized terminology along with uniform cosmetic and functional endpoints must be developed.

The energy based devices for vaginal "rejuvenation," urinary incontinence, vaginal cosmetic procedures, and other vulvo-vaginal disorders: An international multidisciplinary expert panel opinion.

AIMS: Energy-based devices using radiofrequency and laser technologies have gained popularity as therapies for vaginal atrophy, urinary incontinence, and vaginal prolapse. They have been promoted by cosmetic and aesthetic industries for vaginal "laxity" and vaginal "rejuvenation," both of which are undefined conditions and terms. This article aims to review the current available literature and its quality on this emerging technology. METHODS: An international panel of gynaecologists, urogynaecologists, and urologists undertook a review of the available published literature, identifying articles, guidance, and society statements on the use vaginal energy-based devices. RESULTS: There is currently no formal guidance for the use of vaginal energy based therapies. No randomized controlled trials have been published. No comparative studies to existing treatment has been carried out. Studies suggest that vaginal laser can be used in the treatment of vaginal prolapse or "vaginal laxity" and stress urinary incontinence with no quality evidence supporting the use of the therapy for vaginal atrophy or lichen sclerosis. CONCLUSIONS: This international group propose that whilst there remains a paucity of good quality data describing the safety, benefits, and appropriate use of vaginal radiofrequency or laser treatments in gynaecology and urogynaecology, a consensus best practice document by an established scientific community needs to be developed.

The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: An ICS/ISSVD best practice consensus document.

BACKGROUND: The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology is controversial. AIMS: In this best practice document, we propose recommendations for the use of LASER for gynecologic and urologic conditions such as vulvovaginal atrophy, urinary incontinence, vulvodynia, and lichen sclerosus based on a thorough literature review. MATERIALS & METHODS: This project was developed between January and September 2018. The development of this document followed the ICS White Paper Standard Operating Procedures. RESULTS: Most of the available studies are limited by their design; for example they lack a control group, patients are not randomized, follow up is short term, series are small, LASER is not compared with standard treatments, and studies are industry sponsored. Due to these limitations, the level of evidence for the use of LASER in the treatment of these conditions remains low and does not allow for definitive recommendations for its use in routine clinical practice. Histological evidence is commonly reported as proof of tissue regeneration following LASER treatment. However, the histological changes noted can also be consistent with reparative changes after a thermal injury rather than necessarily representing regeneration or restoration of function. The use of LASER in women with vulvodynia or lichen sclerosus should not be recommended in routine clinical practice. There is no biological plausibility or safety data on its use on this population of women. DISCUSSION: The available clinical studies do not present convincing data regarding the efficacy of LASER for the treatment of vaginal atrophy or urinary incontinence. Also, while short-term complications seem to be uncommon, data concerning long-term outcomes are lacking. CONCLUSION: At this point, LASER is not recommended for routine treatment of the aforementioned conditions unless part of well-designed clinical trials or with special arrangements for clinical governance, consent, and audit.