Vaginal Health Index Research Articles

Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial.

To assess whether CO2 laser treatment is more effective than sham application in relieving the most bothersome symptom (MBS) in women with genitourinary syndrome of menopause (GSM). Single-centre, sham-controlled, double-blind, randomised trial. A tertiary centre in Belgium. Sixty women with moderate to severe GSM symptoms. All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely. The primary outcome was the participant-reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short-term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit. The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (-23.60%; 95% CI -36.10% to -11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (-13.20%; 95% CI -22.70% to -3.73%) in those receiving sham applications (p=0.13). There were no serious adverse events reported up to 18 months. In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported.

Effect of Fractional CO2 Laser vs Sham Treatment on Symptom Severity of Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial

<h3>Study Objective</h3> To determine the efficacy of fractional CO₂ laser for treatment of vaginal symptoms associated with menopause. <h3>Design</h3> This study is a double-blind, randomized, sham-controlled trial with 12-month follow-up. Enrollment commenced September 19, 2016, with final follow-up June 30, 2020. <h3>Setting</h3> Outpatient clinic in a single, tertiary referral hospital. <h3>Patients or Participants</h3> Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 90 were recruited. <h3>Interventions</h3> Three treatments using a fractional micro-ablative CO₂ laser system performed 4-8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group. <h3>Measurements and Main Results</h3> The coprimary outcomes were symptom severity assessed by Visual Analog Scale (VAS and Vulvovaginal Symptom Questionnaire (VSQ) at 12 months. Secondary outcomes including quality of life, Vaginal Health Index (VHI) and vaginal histology were assessed. From 85 participants randomized (mean age 57 (SD 8) years), 78 (91.7%) completed 12-month follow-up. From baseline to 12 months between CO₂ laser and sham groups, there was no significant difference in symptom severity (VAS score for overall vaginal symptoms: laser -17.2 vs sham -26.6 (difference 9.4 [95%CI -28.6, 47.5]); VAS score for single most severe symptom: laser -24.5 vs sham -20.4 (difference -4.1 [95%CI -32.5, 24.3]); or VSQ score: laser -3.1 vs sham -1.6 (difference -1.5 [95%CI -5.9, 3.0]). There were no significant differences in quality of life, VHI or histological comparisons between laser and sham treatment. There were 16 adverse events in the laser group and 17 in the sham group including vaginal pain/discomfort (44% vs. 68%), spotting, discharge or lower urinary symptoms. No severe adverse events were reported in either group. <h3>Conclusion</h3> Among women with postmenopausal vaginal symptoms, treatment with fractional CO₂ laser vs sham treatment did not significantly improve vaginal symptoms after 12 months.

New vaginal moisturizer is well-accepted and reduces symptoms related to the genitourinary syndrome of menopause in Brazilian women

Objectives: To evaluate the effectiveness and acceptability of a new vaginal moisturizer composed of a combination of humectants, moisturizers, bioadhesives, and viscosity polymers (sodium hyaluronate 0.1%, polycarbophil 1.5%, carbomer 1.5%, and glycerin 1%) for relief of vulvovaginal symptoms associated with genitourinary syndrome of menopause in Brazilian postmenopausal women. Methods: An open clinical trial was performed with 33 postmenopausal women between 47 and 68 years of age with genitourinary syndrome of menopause symptoms such as vaginal dryness accompanied by pain or discomfort during intercourse. Clinical efficacy in relieving symptoms of genitourinary syndrome of menopause and acceptability were assessed using a Likert scale questionnaire. Efficacy and safety were assessed through gynecological examination, which included visual inspection of the epithelium and vaginal contents, and determination of vaginal pH. Wilcoxon's non-parametric test and paired Student's t-test were used for statistical analyses.Results: After 3 weeks of treatment, most participants reported improvement in GSM symptoms like vaginal dryness (p&lt;0.001), discomfort during or after sexual intercourse (p&lt;0.001), pain during or after sexual intercourse (p&lt;0.001), vaginal odor (p=0.047) and itching (p=0.032) and good acceptability of the moisturizer. There was no alteration in the vaginal health index; however, a reduction in vaginal inflammation (p=0.046) was observed. No clinically significant adverse events were reported by participants. Conclusions: Treatment with non-hormonal vaginal moisturizer for 3 consecutive weeks in postmenopausal women with symptoms of genitourinary syndrome of menopause promoted improvements in vaginal hydration, showing a clinically adequate profile of efficacy and safety, in addition to a satisfactory degree of acceptability.

Comparison of Severity of Genitourinary Syndrome of Menopause Symptoms After Carbon Dioxide Laser vs Vaginal Estrogen Therapy

Vaginal estrogen for genitourinary syndrome of menopause (GSM) should be used with caution in women with contraindications, highlighting the need for effective treatment alternatives. To compare the severity of GSM after vaginal laser vs estrogen therapy. The PubMed, Embase, and Cochrane Library databases were searched for articles published from database inception to April 8, 2022, with no language restrictions. Reference lists were also searched. Randomized clinical trials (RCTs) that compared the use of lasers with vaginal estrogen in adults were selected. Two investigators independently extracted data from included studies. The Cochrane risk of bias tool for RCTs was used to assess risk of bias of each study. A random-effects model was used to pool mean differences (MDs) with 95% CIs. Primary outcomes were Vaginal Analog Scale (VAS; higher scores indicate severer symptoms), Vaginal Health Index (VHI; higher scores indicate better vaginal health), Vaginal Maturation Index (VMI; higher scores indicate higher estrogen effect on the vaginal epithelium), Female Sexual Function Index (FSFI; higher scores indicate better female sexual function), and Sexual Quotient-Female (SQ-F; higher scores indicate better female sexual function) questionnaire scores. Urinary symptoms were assessed as an additional outcome. Data analyses were performed from April 9 to 12, 2022. A total of 6 RCTs with 270 women with GSM were included (135 were randomized to laser therapy and 135 to estrogen therapy; mean age ranged from 54.6 to 61.0 years). No significant differences were found between carbon dioxide laser and vaginal estrogen from baseline to the end of follow-up in overall VAS scores (MD, -0.16; 95% CI, -0.67 to 0.36; I2, 33.31%), VHI (MD, 0.20; 95% CI, -0.56 to 0.97; I2, 83.25%), VMI (MD, -0.56; 95% CI, -1.14 to 0.02; I2, 35.07%), FSFI (MD, -0.04; 95% CI, -0.45 to 0.36; I2, 41.60%), and SQ-F (P = .37 based on 1 study). Other questionnaire-based outcome measures demonstrated no difference between groups from baseline to the end of follow-up for changes in urinary symptoms. This systematic review and meta-analysis of RCTs found that vaginal laser treatment is associated with similar improvement in genitourinary symptoms as vaginal estrogen therapy. Further research is needed to test whether vaginal laser therapy could be a potential treatment option for women with contraindications to vaginal estrogen.

Vaginal laser therapy versus hyaluronic acid suppositories for women with symptoms of urogenital atrophy after treatment for breast cancer: A randomized controlled trial

BackgroundUrogenital atrophy affects >50 % of women after breast cancer (BC) and there is reluctance to use local estrogen for this group. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have been shown to produce symptom relief in women with BC and urogenital atrophy, but have not been tested against each other. The aim of this study was to compare these nonhormonal modalities in women with urogenital atrophy after BC in a randomized fashion. Study designWe randomly assigned 43 women (aged 49–58 years, mean age 54 years) with urogenital atrophy and a history of BC to receive intravaginal laser therapy (2 courses within 1 month) or hyaluronic acid suppositories (3 times/week continuously for three months). The primary endpoint was score on the Vaginal Health Index after 3 months. Secondary endpoints were subjective bother on a numeric rating scale for all urogenital atrophy domains, quality of life, sexual health and pelvic organ prolapse symptoms using validated questionnaires. ResultsOf the 43 women who participated, 22 were randomized to intravaginal laser therapy, and 21 to vaginal suppositories. At 3 months score on the Vaginal Health Index had improved significantly in both groups (p = 0.001), without a significant difference between treatment groups (p = 0.232). Significant improvement was also seen in both groups for subjective bother of urogenital atrophy, quality of life and sexual health, without significant differences between laser or hyaluronic acid therapy. ConclusionsBoth intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after BC suffering from urogenital atrophy. No difference was found between treatment regimens.ClinicalTrials.gov identifier: NCT03816735, https://clinicaltrials.gov/ct2/show/NCT03816735

The Efficacy of Fractional CO2 Laser in the Treatment of Genitourinary Syndrome of Menopause: A Large Prospective Observational Study

Background: Genitourinary syndrome of menopause (GSM) majorly caused by the physiological decline in estrogen, affects up to 90% of menopausal women. Hormonal therapy seems to be an effective treatment, often not executable for contraindication or patient’s low compliance to local or systemic medical therapy. Fractional CO2 laser therapy is an emerging and effective choice for women affected by vulvo-vaginal atrophy (VVA), promoting collagen regeneration and improving blood flow of the vaginal mucosa and elasticity of tissues. Methods: Ninety-two menopausal Patients affected by vulvo-vaginal atrophy (VVA) were considered for the present prospective observational study. All women were treated with Fractional CO2 laser Lumenis AcuPulse in a fractionated sequential mode laser pulse. Patients were requested to complete questionnaires regarding the Female Sexual Functional Index (FSFI), Female Sexual Distress Scale (FSDS) and severity of Most Bothersome Symptoms (MBS) at baseline (T0) and at three-month following three-treatment-sessions (T1). Results: Data indicated a significant improvement of MBS (vaginal itching (p &lt; 0.0001), post-coital vaginal bleeding (p &lt; 0.002), vaginal dryness (p &lt; 0.0001), dyspareunia (p &lt; 0.0001) and dysuria (p &lt; 0.0001), higher Vaginal Health Index Score (VHIS) (4.1 ± 1.21; 95% CI = 3.84–4.35) and reduces pH (–0.53 ± 0.24; 95% CI = 0.48–0.58) after CO2 laser treatment. A significantly improvement of FSFI Total score (p &lt; 0.0001) and FSDS (p &lt; 0.0001) have been demonstrated. Conclusions: Fractional CO2 laser improves vaginal health as well as signs and symptoms associated with GSM, while significantly elevating quality of life and sexual functionality among postmenopausal symptomatic women.

Fractional Carbon Dioxide Laser Improves Vaginal Laxity via Remodeling of Vaginal Tissues in Asian Women.

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.

Efficiency of treatment and diagnostic algorithms in the rehabilitation program of women after hysterectomy with opportunist salpingectomy due to uterine myoma

Objectives: to determine the effectiveness of the rehabilitation program in women of reproductive age with uterine fibroids for correction of genitourinary syndrome after hysterectomy with opportunistic salpingectomy.Materials and methods. 160 women were examined after hysterectomy with fallopian tubes. State of the urogenital tract and urogenital dysfunction researched with the using the POP-Q system, the Barlow scale, vaginoscopy. Also it was used evaluation of the vaginal pH and mucosal microbiota state, assessment of the vaginal health index according to G. Bochmann, assessment of the impact of vulvovaginal symptoms on the life’s quality with the MOS SF-36 questionnaire in the dynamics of the postoperative period. The treatment algorithm included local preparations of hyaluronic acid, lactobacillus preparations in combination with vitamin D solution, in case of a severe course – topical estrogens, in case of vasomotor symptoms – estradiol 50 μg/day and vitamin D 4000 IU daily or 20,000 IU once a week.Results. Manifestations of genitourinary syndrome were revealed 1 year after surgery, namely: hypotrophy of the vaginal mucous membrane in 36.3% of women, urinary incontinence in almost a third of patients, prolapse of the vaginal walls of the I–II degree in 8.8% of women, a pathological microscopic picture in 68.1% of female. The proposed algorithms in the rehabilitation program made it possible to eliminate or reduce the severity of genitourinary symptoms 5 years after hysterectomy, in particular, to reduce the frequency of vulvovaginal atrophy by 25%, to normalize the biocenosis and pH of the vaginal contents, to reduce the clinical manifestations of urination disorders (pollakiuria and nocturia by 14% and 12,8%, respectively), feeling of incomplete emptying of the bladder by 12.9%, stress urinary incontinence by 17.9%, vaginal prolapse by 13.3% compared to the group with standard postoperative management.Conclusions. Hysterectomy with opportunistic salpingectomy for uterine fibroids has a positive effect on the life’s quality of patients by improving the physical comfort due to the reduction of clinical symptoms of uterine fibroids. However, changes in the quality of life after surgical intervention associated with disturbances in the psycho-emotional sphere were recorded in 49.4% of women, including those provoked by the manifestation of genitourinary syndrome in 19.3%. The proposed algorithm in the rehabilitation program made it possible to reduces the severity of genitourinary symptoms.

Ultrasonographic measurement of vaginal thickness: Relation to menopausal status and genitourinary syndrome of menopause.

To compare the total vaginal wall thickness (TVT) and total mucosal thickness (TMT) measurements of premenopausal and postmenopausal women measured by ultrasonography and to determine the association of these measurements to findings and symptoms of genitourinary syndrome of menopause METHODS: Healthy volunteers, 80 postmenopausal and 80 premenopausal, were included. Ultrasonographic TVT and TMT measurements, vaginal health index (VHI) scores and pH values were recorded. The daily impact of vaginal aging (DIVA) scale was administered to women in the postmenopausal group. TVT measurements of the postmenopausal group (6.55 ± 2.00 mm) were lower than the premenopausal group (10.37 ± 2.11 mm) (p: 0.000). TMT measurements of the postmenopausal group (1.46 ± 0.50 mm) were lower than the premenopausal group (2.19 ± 0.60 mm) (p: 0.000). The VHI scores of the postmenopausal group were significantly lower than the premenopausal group, the pH value was higher (p < 0.05). Considering all women TVT and TMT measurements were inversely correlated with pH values and positively correlated with total VHI scores. There was no significant correlation between any component scores of the DIVA scale and TVT, TMT, pH, and VHI total (p > 0.05). TVT and TMT measurements in postmenopausal women are significantly lower than premenopausal women. Examination findings and thickness measurements are correlated. Transabdominal ultrasonography is a method that can be used in the evaluation of vaginal thickness which is not painful for the patient, is easy to apply and gives results consistent with the examination findings. However, measurements and examination findings do not correlate with the DIVA scores in postmenopausal women.

Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial

Vaginal looseness and decreased sensation during intercourse is prevalent in up to 30%-55% of premenopausal women. The efficacy and safety of CO2 laser have been demonstrated for these indications; however, the effect is temporary, up to 6-12 months. No studies regarding the efficacy and safety of adjuvant laser treatments have been conducted to date. To evaluate the efficacy and safety of a single maintenance CO2 laser treatment in women with vaginal looseness and a concurrent decline in sexual sensation during intercourse. This prospective double-blinded randomized controlled trial included premenopausal women who experienced significant temporary improvement in symptoms following previous treatment with CO2 laser due to the abovementioned indications. Participants were randomized to either a single CO2 laser treatment or a single sham treatment. Treatment efficacy evaluated with the female sexual function index (FSFI) and the vaginal health index (VHI). Overall, 119 women were included in the study. Mean VHI and FSFI scores were significantly higher in the study group compared to the control group at three months post-treatment (17.34±1.39 vs 12.86±2.23, P=.023 and 30.93±1.79 vs 25.78±1.87, P=.044, respectively). In the study group, both VHI and FSFI returned to baseline at six months post-treatment. The median rate of sexual intercourse per month was increased in the study group at three months post-treatment (8 vs 4, P=.011), and returned to baseline at six months post-treatment. Maintenance laser treatment provides a temporary non-surgical alternative for women with vaginal looseness and associated sexual dysfunction, though treatment effect seems to be limited to less than 6 months, requiring additional maintenance sessions. The strengths of the current study include a randomized-sham controlled design. Furthermore, VHI was used as an objective evaluation tool, in addition to the FSFI, and assessment of the rate of sexual intercourse. The homogeneity and the relatively small sample size of the cohort is a limitation, and calls for caution in interpretation of the results, and the use of CO2 laser treatment in different age groups and populations. A single maintenance laser treatment in women who previously underwent successful treatment with laser is an effective, well-tolerated, and safe procedure for treating symptoms of vaginal looseness and sexual dysfunction, though effects are temporary. Lauterbach R, Aharoni S, Farago N, et al. Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial. J Sex Med 2022;19:1404-1411.

Long-term use of ospemifene in clinical practice for vulvo-vaginal atrophy: end results at 12 months of follow-up

Objective To assess the improvement in vulvovaginal atrophy (VVA) of postmenopausal women treated with oral ospemifene 60 mg/day under conditions of routine clinical practice after 12 months of follow-up. Methods The AYSEX study is a Spanish observational, prospective, and unicentric study in which five gynecologists recruited postmenopausal women with VVA in routine clinical practice treated with oral ospemifene 60 mg/day as an appropriate therapeutic option. Vaginal health, the most bothersome symptoms, sexual health, endometrial safety, bone resorption markers, bone densitometry, mammography, treatment satisfaction, and quality of life were assessed at baseline and after 12 months using appropriate scales. Results A total of 100 postmenopausal women cytologically and clinically diagnosed with VVA were included in the study. After 3 months of treatment with ospemifene, a significant improvement was observed in all domains of Vaginal Health Index. This improvement was maintained at month 12 and only one patient remained with vaginal atrophy. In addition, a significant improvement was observed in the most bothersome symptoms, sexual function, and quality of life. There was no significant change in endometrial thickness, mammography, and bone health during the 12 months of treatment. Conclusions This study in routine clinical practice conditions confirms the results previously reported by randomized controlled trials, including a significant improvement in VVA, sexual function, quality of life, endometrial safety, and satisfaction with the treatment.

Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study.

This prospective, open-label, multicentre, multinational, randomised trial investigated the non-inferiority of treatment with a vaginal hormone-free moisturising cream compared to a vaginal estriol (0.1%) cream in a panel of post-menopausal women suffering from symptoms of vulvovaginal dryness in a parallel group design. In total, 172 post-menopausal women were randomly allocated to either one of the two treatments, each administered for 43 days. The primary endpoint was the total severity score of subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) of the respective treatment period. Secondary endpoints were severity of single subjective symptoms (including dyspareunia if sexually active), impairment of daily life, Vaginal Health Index, as well as assessment of safety. In both groups, women treated with hormone-free moisturising cream and those treated with estriol cream, total severity score improved significantly compared to baseline by 5.0 (from 6.1 to 1.1) and by 5.4 (from 6.0 to 0.6), respectively, after 43 days of treatment (p < 0.0001). One-sided test of baseline differences (for a clinically relevant difference Δ = 1.5) confirmed the hormone-free moisturising cream to be non-inferior to the estriol cream. Severity of dyspareunia as well as impairment of daily life due to subjective symptoms, significantly improved for both treatment groups (p<0.0001). Subgroup analysis of women with mild or moderate impairment of daily life at baseline caused by "vaginal dryness" symptoms benefited from both creams, while women with severe impairment showed a significantly greater benefit from the estriol cream (p = 0.0032). Both treatments were well tolerated with no serious adverse events occurring. This study provides clinical evidence that a hormone-free vaginal moisturising cream cannot only improve vaginal dryness compared to an 0.1% estriol cream but also can relieve dyspareunia as well as improve woman's impairment of daily life, justifying its use as a first choice for mild or moderate vulvovaginal dryness symptoms.

Examining vaginal and vulvar health and sexual dysfunction in patients with interstitial cystitis (UNICORN-1 study).

The Vaginal Health Index Score (VHIS) and vulvodynia swab tests are used to assess vaginal health and vulvodynia. However, few studies have used these tests in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). IC/BPS is a chronic, debilitating disorder, characterised by urinary frequency, urinary urgency and pelvic pain. It adversely affects organs adjacent to the urinary system, leading to complications of sexual dysfunction. This study was aimed at understanding sexual dysfunction in patients with IC/BPS, as well as deterioration of vaginal health and vulvodynia. This study compared the vaginal health of IC/BPS patients with that of asymptomatic control individuals. The Pain Urgency Frequency (PUF) score, Female Sexual Function Index (FSFI), VHIS, and vulvodynia swab tests, were used as tools. The PUF and FSFI are questionnaire-based surveys of bladder symptoms and sexual function respectively. VHIS evaluation and vulvodynia swab tests are performed by physicians. The PUF was used to assess baseline IC/BPS symptoms to validate the patient population, and FSFI, vulvodynia swab tests and VHIS were used to determine between-group differences. Thirty-seven patients were recruited in each group. The IC/BPS group had a higher PUF score (18.19±3.51 vs 3.56±2.35; p<0.05), worse total FSFI (15.72±4.46 vs 26.3±4.93; p<0.05), and worse vulvodynia swab test and total VHIS (11.59±2.87 vs 22.05±3.05; p<0.05) scores than those of the control group. Asian women with IC/BPS experienced greater sexual dysfunction, worsened vaginal health and increased vulvodynia compared with control individuals. Information on vaginal and vulva health is very useful in evaluating IC/BPS patients.

MP37-01 PILOT TRIAL FOR PIVoT: PREVENTION OF RECURRENT URINARY TRACT INFECTION USING VAGINAL TESTOSTERONE

You have accessJournal of UrologyCME1 May 2022MP37-01 PILOT TRIAL FOR PIVoT: PREVENTION OF RECURRENT URINARY TRACT INFECTION USING VAGINAL TESTOSTERONE Mariela Martinez, Arshia Sandozi, Jeffrey Lee, Liliya Vafina, Cassandra Pond, Robert Adelson, Elie Kaplan-Marans, Katiana Vazquez-Rivera, Annette Lee, and Allison Polland Mariela MartinezMariela Martinez More articles by this author , Arshia SandoziArshia Sandozi More articles by this author , Jeffrey LeeJeffrey Lee More articles by this author , Liliya VafinaLiliya Vafina More articles by this author , Cassandra PondCassandra Pond More articles by this author , Robert AdelsonRobert Adelson More articles by this author , Elie Kaplan-MaransElie Kaplan-Marans More articles by this author , Katiana Vazquez-RiveraKatiana Vazquez-Rivera More articles by this author , Annette LeeAnnette Lee More articles by this author , and Allison PollandAllison Polland More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002591.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Recurrent urinary tract infections (rUTI) in postmenopausal women have been associated with changes in vaginal flora. Vaginal estrogen treats atrophy thereby restoring flora, which prevents UTIs. While estrogen is effective, some patients have contraindications or are unwilling to use it. Vaginal testosterone cream (VT) has been shown to improve atrophy, however, its effects on flora and rUTIs are unknown. The purpose of this study was to determine the effect of VT versus placebo on vaginal flora in postmenopausal women with rUTI. METHODS: This randomized, double- blind pilot study enrolled postmenopausal women with rUTIs. Patients were randomized to VT or placebo. Vaginal health index (VHI) and vaginal swab to assess flora via DNA sequencing were collected at baseline and at one month follow up. RESULTS: A total of 21 patients were enrolled. Average VHI at enrollment was 16.68±4. There was no difference between groups at baseline with regard to VHI. There was diversity of vaginal flora in both treatment arms at baseline (Figure 1). Among patients who completed follow up, almost half of those in the VT arm had an increase in relative abundance of lactobacilli, which was not seen in the placebo patients. As compared to the placebo arm, a greater number of patients in the VT arm had a decrease in relative abundance of uropathogens such as Bacteroides and Pseudomonas. The majority of patients in the VT arm had improvement in VHI, which was not seen with placebo at one month. Four patients developed UTIs during the study, two in each arm. CONCLUSIONS: Initial data demonstrates increased abundance of lactobacilli and improvement in VHI at one-month post treatment with VT. Although there was no difference in the number of patients who developed UTIs between groups, longer treatment follow up and increased patient enrollment will be valuable in determining if VT is effective for UTI prevention. Source of Funding: AUA Urology Care Foundation Residency Research Award © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e607 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mariela Martinez More articles by this author Arshia Sandozi More articles by this author Jeffrey Lee More articles by this author Liliya Vafina More articles by this author Cassandra Pond More articles by this author Robert Adelson More articles by this author Elie Kaplan-Marans More articles by this author Katiana Vazquez-Rivera More articles by this author Annette Lee More articles by this author Allison Polland More articles by this author Expand All Advertisement PDF DownloadLoading ...

Vaginal non-ablative Er:YAG laser sexual dysfunction therapy in women with interstitial cystitis/bladder pain syndrome: A Case Series

ABSTRACT Introduction Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic debilitating disease characterized by urinary frequency, urgency, and pelvic pain. Different studies have evaluated sexual well-being and e female sexual dysfunction (FSD) in IC/BPS patients. FSD in women with IC/BPS consists of dyspareunia, altered sexual desire, reduced orgasm frequency and vaginal insufficient lubrication. Recently, it has been repeatedly demonstrated that vaginal non-ablative erbium YAG laser (VEL) therapy can improve objective and subjective symptoms in different conditions. In our experience, VEL was very effective in various indications (stress urinary incontinence, mixed urinary incontinence, overactive bladder, genitourinary syndrome of menopause and FSD). In this study we evaluated the effects of VEL on FSD in women suffering from IC/BPS. Materials and methods This is case series study in which women with IC/BPS were also reporting FSD. The patients were treated with VEL with protocol in which the laser firstly irradiated the whole anterior vaginal wall and then also the entire vaginal canal. Local topical anesthesia was applied to the vagina before the laser irradiation. The therapy consisted in 1 treatment every 30 days, for 3 months. For the assessment of treatment effects we evaluated the personal history including: age at onset of IC/BPS and FSD, type of IC/BPS, bladder IC/BPS surgeries, the numeric rating scale-11 (NRS-11), O'Leary-Sant interstitial cystitis symptom and problem indexes (ICSI and ICPI), functional bladder capacity, daily urinary frequency, female sexual function index (FSFI) and vaginal health index score (VHIS). Follow-up was done 6 months from the first laser session. Potential adverse effects were observed at every visit as well as at 6 months follow-up. Results Six women were treated with the three sessions of VEL and followed for 6 months. The FSFI and VHIS significantly improved in all patients. The NRS-11 scores and the part of pain question of ICSI and ICPI improved as well. The bladder capacity and daily urinary frequency showed a marginal improvement. The therapy effects lasted for 6 months from the first treatment. All observed adverse effects were mild and transient. Conclusion Women suffering from IC/BPS have often impaired sexual life. Our data suggest that, besides being safe, VEL treatment can improve sexual life reducing also pain symptoms in IC/BPS patients. Further larger studies are needed in order to ascertain the relations between vaginal conditions and bladder pain, evaluating the possible role of VEL as a new approach for the treatment of FSD in IC/BPS women. Disclosure Work supported by industry: no.

Efficacy of intradermal hyaluronic acid plus polynucleotides in vulvovaginal atrophy: a pilot study

Objective This study aimed to evaluate the safety and efficacy of vulvovaginal intradermal injections of polynucleotides (PN) combined with hyaluronic acid (HA) in postmenopausal women affected by vulvovaginal atrophy (VVA). Materials and methods Postmenopausal women affected by VVA were treated with vulvar and vaginal intradermal injections of one prefilled syringe of 2 ml PN/HA every 2 weeks for four sessions. Patients were evaluated at T0 (baseline), T1 (after session 4) and T2 (1 month after session 4). Evaluation of the treatment was assessed by three international validated questionnaires: Vaginal Health Index (VHI), Vulvar Health Index (VuHI) and Female Sexual Function Index (FSFI). The Wilcoxon matched-paired signed-rank test was used to compare the differences in VHI, VuHI, FSFI and FSFI domains within the groups. Statistical significance was set at p < 0.05. Results Fifty patients were included in the study (mean age 59.9 ± 7.6 years). Overall, the VHI, VuHI and FSFI reported statistically significant differences between baseline and T1 (p < 0.001) and between baseline and T2 (p < 0.001). All FSFI domains registered a statistically significant increase between baseline and T2 (p < 0.001). No complications or side effects were observed. Conclusions Vulvovaginal intradermal injection of PN/HA is a safe, effective treatment, is not expensive and is a reproducible procedure in postmenopausal women with VVA.

Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy

Among treatments for vulvo-vaginal atrophy (VVA), there is a new kind of energy-based device, the non-ablative CO2 laser. This study aimed to assess the efficacy and safety of the non-ablative CO2 laser in menopausal women with VVA as a monotherapy or in association with vaginal estriol or moisturizer. Seventy-five women with VVA received laser treatment (Laser group), laser plus estriol gel (Laser+E) or laser plus moisturizers (Laser+M). The study protocol consisted of 3 monthly laser sessions (t0, t1, t2) and a gynecological examination at baseline and 1 month after last laser treatment (t3). Objective measures included VHI (Vaginal Health Index) and VuHI (Vulvar Health Index); subjective symptoms of VVA (Dryness, Burning, Itching, Dysuria) evaluated via visual analog scales, sexual function evaluated by FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) and MENQOL (Mopause-specific Quality Of Life). Adverse events and discomfort encountered during the procedure were also assessed. Primary outcomes were the evaluation of VHI and VuHI and secondary outcomes were changes in VVA symptoms (VAS), sexual function (MENQOL, FSFI, FSDS) and discomfort during the procedure. Seventy-five women (25 in Laser, 25 in Laser+E and 25 in Laser+M group) completed the study. At t3, mean VHI, VuHI, dryness, burning and itching VAS scores improved significantly with no differences between the groups. The lubrication domain of FSFI improved significantly only in the Laser+M group, while the pain domain improved significantly in all women with no differences between the groups. FSFI and FSDS overall scores and MENQOL sexual domain improved in all women with no significant difference between the groups. The mean score of the pain during the procedure was low at t0 and did not change throughout the study. This study extends knowledge concerning the effectiveness of a new non-ablative CO2 laser in post-menopausal women with VVA. This is one of the first studies on this kind of laser and is the first to compare the effectiveness of laser treatment alone or in combination with vaginal estriol or moisturizers. Parameters of VVA and sexual function were evaluated using validated tools. Study limitations include short follow-up time, the limited number of participants and the absence of a sham-controlled group. Non-ablative CO2 laser seems to be an effective treatment for VVA in menopausal women. Our preliminary data shows that it can be effective as monotherapy or with adjuvant treatments.

Safety of prasterone in breast cancer survivors treated with aromatase inhibitors: the VIBRA pilot study

Background Due to safety concerns on estrogen-based treatments for genitourinary syndrome of menopause (GSM) in breast cancer survivors (BCS), new options are appearing, such as androgen-based treatments, which according to proprieties would not be transformed systemically to estrogens in patients receiving aromatase inhibitors (AIs). Objective The aim of this pilot study is to assess the security and efficacy of vaginal prasterone (dehydroepiandrostenedione [DHEA]) in BCS treated with AIs. Methods This open, prospective, pilot study included 10 BCS treated with AIs. All participants complained of severe GSM. DHEA was administrated as a vaginal ovule. Participants were instructed to use one ovule every night during the first month, and one ovule every two nights for the entire five remaining months. The patients were requested to attend seriated visits after the beginning of the prasterone treatment to evaluate symptoms, physical improvement and serum estradiol. Results Mean serum estradiol remained low from 3.4 pg/ml to 4.3 pg/ml (p = 0.9136) after 6 months of follow-up. The visual analog scale of dyspareunia improved from 8.5 to mean values after treatment of 0.4 (p = 0.0178). The Vaginal Health Index (VHI) scale and Female Sexual Function Index improved from 9.75 to 15.8 (p = 0.0277) and from an initial score of 11.2 to 20.6 (p = 0.0277), respectively. Vaginal pH changed from basal 8.1 to final 6.5 (p = 0.0330). Conclusion Symptoms and physical examination regarding sexuality and vaginal health improved significantly, while serum estradiol remained at low levels. Prasterone seems a safe and effective option to treat GSM in BCS receiving AIs.

Clinical evaluation of autologous platelet rich plasma injection in postmenopausal vulvovaginal atrophy: A pilot study.

There is a lack of published data investigating injection of autologous platelet rich plasma (A-PRP) alone in the treatment of postmenopausal VVA. In this pilot study, we aimed to investigate the safety and efficacy of injection of A-PRP alone in postmenopausal VVA in women without the history of cancer breast to explore its utility as a hormone free therapy for postmenopausal VVA and for vulvovaginal rejuvenation. In this pilot study, 47 women with postmenopausal VVA were included. Vulvovaginal condition was evaluated at the baseline by vaginal health index (VHI). Impact of VVA on quality of life and sexual life was evaluated at the baseline by vulvovaginal symptom questionnaire (VSQ). Treatment protocol was 2sessions of A-PRP injection with 1month interval. Response was evaluated 1month after the last session by VHI and VSQ. Side effects were also evaluated. Postmenopausal VVA was significantly improved by A-PRP injection as indicated by significant improvement of total VHI score and its items at 1month post-treatment (p value <0.001). Moreover, there was significant improvement of burning, hurting, being irritated, being dry, discharge, desire to be intimate, sexual relationships, pain during sexual activity, and dryness during sexual activity at 1month post-treatment as indicated by VSQ (p value =0.045 for being dry and <0.001 for other items). Autologous platelet rich plasma injection is safe and effective as minimally invasive monotherapy for postmenopausal VVA without history of cancer breast and hence for vulvovaginal rejuvenation.

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.

BackgroundThere 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.MethodsThis 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).ResultsAbout 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.ConclusionsThese 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.