Tampon Insertion Research Articles

Does One Measure Fit All? The Role of Experimentally Induced Pain Tests in the Assessment of Women with Provoked Vestibular Pain.

A diagnostic algorithm was recently suggested to address the underlying mechanisms of provoked-vestibulodynia (PVD). It delineates four subgroups (Hormonal-associated, Augmented-anterior, Hymenal-associated and Hypertonicity-associated), each manifesting a distinctive vulvar pain-hypersensitivity regarding location (circumferential vs posterior-only vestibulodynia) and pain characteristics. We aimed to explore the significance of various experimentally induced vulvar pain measures in the manifestation of pain hypersensitivity in each subgroup. Women with PVD (n = 113) and 43 controls reported pain intensity provoked during vaginal penetration and tampon insertion. Vestibular tenderness (anterior and posterior) was assessed by Q-tip test, and pressure stimulation delivered to the puborectalis assessed muscle tenderness. Pain thresholds were measured using a vulvar-algesiometer. These measures were compared between patients and controls and among the PVD subgroups. Correlations between the clinical and experimentally induced-pain measures were assessed. Finally, to address whether the association between experimentally induced-pain measures and dyspareunia severity is mediated by hypertonicity, the conditional indirect effect was analyzed in each subgroup. Compared to controls, augmented vulvar pain-hypersensitivity and hypertonicity were observed among patients (p < 0.001). ANOVA revealed no subgroup differences in dyspareunia severity. Nevertheless, some experimentally induced-pain measures were differently correlated with dyspareunia intensity in each subgroup, allowing discrimination of subgroups according to the unique findings of vulvar pain-hypersensitivity. The degree of pelvic floor muscle-hypertonicity mediated the association between vulvar pain-hypersensitivity and dyspareunia severity, emphasizing the key role of hypertonicity in distinguishing between subgroups. The findings offer more evidence of variations among PVD subtypes, demonstrating that insertional dyspareunia may originate from dissimilar alterations in the mucosal and muscular tissues. The results also emphasize the significance of utilizing a wide battery of tests to capture different experimentally induced-pain measures, revealing the unique patterns of vulvar pain-hypersensitivity in each subgroup.

(070) SUCCESSFUL TREATMENT OF NEUROPROLIFERATIVE VESTIBULODYNIA IN MENOPAUSAL PATIENTS

Abstract Introduction As pain symptoms from neuroproliferative vestibulodynia (NPV) often arise at initial attempt at tampon insertion or penetrative sex, most vestibulodynia patients present in their 20’s or 30’s. Consequently, individuals who reached this age prior to 2004-when Dr. Bornstein and colleagues delineated the excess mast cell and nerve pathology-had limited opportunity for successful NPV diagnosis and treatment. Menopausal patients often experience vulvar pain with genitourinary syndrome of menopause (GSM) due to the paucity of sex steroid hormonal support of their genital tissues. While symptoms of painful penetration are similar in both of these conditions, NPV is diagnosed when severe allodynia/hyperalgesia is still present with a normal or corrected hormonal milieu. A treatment for NPV is complete vestibulectomy surgery, performed in premenopausal eugonadal patients. However, in hormonally depleted patients with GSM, the vaginal tissue is thinner and less robust making it less optimal for reconstructive surgery. Objective To examine the intersection of genitourinary syndrome of menopause and neuroproliferative vestibulodynia symptoms in a subgroup of at-risk patients and to report techniques for optimizing management of this patient population. Methods We reviewed charts of two menopausal patients with NPV and report a clinical strategy for successful management. Results Two patients, ages 58 and 63 reported histories consistent with NPV during their reproductive years-one with lifelong entrance pain with any insertion and one with pain-free penetration prior to experiencing severe burning upon use of topical miconazole for candidiasis. At presentation, both had entry pain symptoms consistent with GSM and NPV. Since NPV is a diagnosis of exclusion, each was treated for GSM with intravaginal DHEA and vestibular topical compounded testosterone/estradiol cream. After 6 months, vestibular pallor and erythema resolved, however, cotton-tip swab testing scores did not improve. A positive improvement with vestibular anesthesia testing was consistent with NPV. Each underwent a complete vestibulectomy with vaginal advancement flap with successful wound healing and no adverse events despite their age and prior GSM diagnosis. Both patients report “very much better” symptoms on post-op Patient Global Impression of Improvement. Immunohistochemical staining of excised vestibular tissue confirmed a high density of CD117 and PGP9.5 staining consistent with an NPV diagnosis. Each patient has continued their menopause treatments post-op. Conclusions We report on two menopausal patients with NPV who had classic symptoms of severe allodynia/hyperalgesia in their reproductive years but who were not managed as NPV patients due to lack of knowledge at that time. Treating the GSM first with hormone replacement may restore health to vaginal tissues, thereby allowing the excised vestibular region to be covered with a vaginal advancement flap. Managing GSM symptoms prior and then undergoing vestibulectomy allowed them to have pain-free penetration. Disclosure No.

(001) Excess Density of Mast Cells and Nerves with Neuroproliferative Vestibulodynia: Defining the Extent of the Vestibulectomy Surgical Excision

Abstract Introduction Congenital neuroproliferative vestibulodynia (NPV) is associated with lifelong entrance dyspareunia, starting with initial tampon insertion. Acquired NPV is associated with pain-free penetration until after a severe candidiasis infection and/or allergic reaction to a locally applied agent. NPV is diagnosed by ruling out other forms of vestibulodynia. Based on immunohistochemical examination of excised vestibular tissue specimens from women with NPV, the pathophysiology is related to high density of mast cells and nerves throughout the entire surgical specimen If conservative, non-operative strategies fail, or are not appropriate, surgical excision may be considered as vestibulectomy has a high success rate. The extent of surgical excision, however, varies by surgeon, from an excision of the posterior vestibule to a wider excision involving posterior vestibule along with left and right anterior vestibule, millimeters next to the urethral meatus. Few providers perform an even wider excision when appropriate including vestibular tissue inferior to the clitoris/right and left frenulum, and superior to the urethral meatus, the “12:00” vestibule. The extent of vestibular tissue excision related to patient outcome in NPV has not been studied. Objectives This study compares the density of mast cells and nerves from the 12:00 vestibule to the posterior and left and right anterior vestibule using immunohistochemistry. Methods Surgical specimens (12:00 vestibule; posterior and left and right anterior vestibule) from 6 women (mean age 27 +/− 11 years) were fixed in formalin, paraffin embedded blocks and labelled. 5 um sections from each block were stained with hematoxylin and eosin and slides analyzed by light microscopy. Antibodies to CD117 and PGP 9.5 were used for immunostaining. Multiple regions were examined and photographed using a Zeiss AxioCam HR high resolution digital microscope. Density of CD117 and PGP9.5 positive cells were determined by counting the number of dark brown stained cells per high-power field (hpf = x 20 magnification). Specimens from control subjects have values of 8 mast cells or less per hpf, as reported by Bornstein. Results High densities of CD117-positive cells in vestibular epithelium and stroma were noted in the 12:00 vestibule (mean density of 43 +/− 18 per hpf) versus in the posterior and left and right anterior vestibule (mean density of 38 +/− 14 per hpf). High densities of PGP9.5-positive cells were noted in vestibular stroma in the 12:00 vestibule (mean density of 31 +/− 20 per hpf) versus the posterior and left and right anterior vestibule (mean density of 33 +/− 18p er hpf). Figures 1 and 2 show CD117-positive cells and PGP9.5 positive cells, consistent with excess mast cells and nerves, respectively at the 12:00 vestibule and from the posterior and left and right anterior vestibule. Conclusions We demonstrate, for the first time, that the 12:00 vestibule contains the same increased number of mast cells and nerves as the rest of the vestibule. If anesthetizing that region pre-operatively provides pain relief, excision during surgery should be considered. In patients with NPV, excising the 12 o’clock region at the top of the vestibule may result in improved post-operative success rate. Disclosure No.

(003) Immunohistochemical Staining of Vestibular Tissue from Patients Suspected of Having Neuroproliferative Vestibulodynia: A Case Series

Abstract Introduction Neuroproliferative vestibulodynia (NPV) is a genetic form of vestibulodynia associated with increased density of mast cells and nerves in vestibular tissue. In congenital NPV, umbilical hypersensitivity and a history of absent pain-free penetration including tampon insertion is associated. In acquired NPV, entrance dyspareunia often occurs after severe or recurrent candidiasis or allergic reaction to a topical agent. The diagnosis of NPV is primarily made by excluding other forms of vestibulodynia including: pelvic floor muscle hypertonicity (in part because of pain throughout the entire vestibule); dermatologic pathology (e.g. lichen sclerosus, lichen planus) is absent; inflammatory pathology (e.g. vaginitis, candidiasis) is absent; hormonally-mediated pathology is ruled- out (normal calculated free testosterone or following unsuccessful treatment with local vestibular testosterone/estradiol or systemic testosterone); and cauda equina or pudendal nerve pathology is ruled out (vestibular anesthesia testing temporarily eliminates pain). Few providers performing surgical treatment of NPV by complete vestibulectomy and vaginal advancement flap reconstruction confirm the increased density of CD117-positive cells (consistent with mast cells) and PGP9.5 positive cells (consistent with nerves) in the vestibular epithelium and/or stroma of excised vestibular tissue specimens. Objectives To confirm the diagnosis of NPV, surgical specimens from patients undergoing complete vestibulectomy were examined using immunohistochemical staining to observe if there was an increased density of CD117-positive cells and PGP9.5 positive cells in the vestibular epithelium and/or stroma, consistent with excess mast cells and nerves, respectively. Methods Vestibular tissues were placed in fixed formalin paraffin embedded blocks. 5 um sections from each block were stained with hematoxylin and eosin and the slides analyzed by light microscopy. Antibodies to CD117 and PGP 9.5 were used for immunostaining. Multiple regions of the immunohistochemically stained slides were examined and photographed using a Zeiss AxioCam HR high resolution digital microscopy. The density of CD117-positive cells and PGP9.5 positive cells were determined by counting the number of dark brown stained cells in a high-power field (HPF = x 20 magnification). Specimens from control subjects have values of 8 mast cells or less per hpf as reported by Bornstein. Results Specimens from 21 women (mean age 29+/−13 years) who had complete vestibulectomy with vaginal advancement flap surgery between June 2019 and November 2020 underwent immunohistochemical staining, with NPV confirmed in all. High densities of both CD117-positive cells (mean density of 39+/−15 per HPF) in vestibular epithelium and stroma, and high densities of PGP9.5-positive cells (mean density of 27+/−16 per HPF) were noted in vestibular stroma in all specimens. Figures 1 and 2 show CD117-positive cells and PGP9.5 positive cells, consistent with excess mast cells and nerves, respectively. Findings and photos of immunohistochemical staining are shared with patients post-operatively, which validates the surgery for them. Conclusions Patients are empowered knowing the underlying pathology of their entrance dyspareunia which was previously only suspected to be NPV. Future considerations include pre-operative vestibular biopsies to determine the necessity of surgery and immunohistochemical staining with calcitonin gene-related peptide to determine the possibility of medical management of NPV. Disclosure No.

(083) Baseline Characteristics of Participants in a Multicenter Randomized Clinical Trial of Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulodynia: UPDATe)

Abstract Introduction Vestibulodynia (VBD) is a common cause of sexual pain that affects ~14 million women in the United States. Many different therapies are used on a trial-and-error basis which can delay effective care. Two distinct VBD subtypes may benefit from different types of treatment: 1) VBD peripheral (VBD-p) - pain localized to the vulvar vestibule and 2) VBD central (VBD-c) - VBD and &amp;gt;1 chronic overlapping pain condition(s) affecting remote body regions. Thus, we are evaluating the efficacy of peripheral, central, and combined treatments for VBD-p vs VBD-c. We will also evaluate cytokine and microRNA biomarkers to help determine pathophysiology and predict treatment response. Objective To describe the design and present baseline participant characteristics of our ongoing RCT for VBD. Methods This is a multi-site randomized, double-blind trial that will enroll participants to one of four parallel arms: 1) peripheral treatment with 5% lidocaine/0.5 mg/ml 0.02% estradiol compound cream and placebo pills, 2) central treatment with tricyclic antidepressant nortriptyline pills and placebo cream, 3) lidocaine/estrogen cream and nortriptyline pills, or 4) placebo cream and placebo pills. The treatment phase will last 16 weeks, with clinical outcome measures and biomarkers assessed at 4 time points (0, 8, 16, and 24 weeks). We will enroll 400 women 18-50 years who report tenderness at the vulvar vestibule and report &amp;gt;3/10 pain with tampon insertion on a numeric rating scale (NRS). Primary outcome is pain with tampon test. Secondary outcomes include self-reported pain on the McGill Pain Questionnaire, psychosocial measures, pressure pain thresholds (PPTs) measured at the vaginal vestibule, levator ani muscles, and remote body sites, and levels of cytokines and microRNAs in local vaginal and circulating blood samples using multiplex assays and RNA sequencing to determine the ability of these biomarkers to predict treatment response. Results So far 135 subjects have enrolled and 78 of these have completed the study. Enrollment remains open, with 27 subjects active and 30 subjects discontinued. Mean (range) age is 26.9 (18-48) years and body mass index is 23.7 (16-37). Self-disclosed racial identity of subjects is: White (67.4%), Asian (14.1%), Multiracial (9.6%), Black (8.9%), with 14.8% of subjects identifying as Hispanic or Latino. Of the enrolled subjects, 94/135 (69.6%) subjects are categorized VBD-c, and 41/135 (30.4%) are categorized VBD-p. Of those categorized as VBD-c, fibromyalgia syndrome (39.3%), endometriosis (34.1%), back pain (25.20%), irritable bowel syndrome (19.3%), chronic headaches (16.3%), temporomandibular disorder (11.1%), interstitial cystitis (10.4%) and chronic fatigue syndrome (1.5%) have been reported. At baseline visit, subjects report an average tampon test score of 4.2 (□ 2.11) and 93.3% of subjects report pain during vaginal intercourse. Conclusions We have launched a multicenter randomized trial to evaluate the efficacy of peripherally and centrally acting medications used for treating unique VBD subtypes based on distinct clinical and biological signatures. We hope to advance our knowledge of the pathophysiologic mechanisms underlying VBD-p and VBD-c, determine the efficacy of peripheral, central, and combined therapies in alleviating pain in women with VBD-p and VBD-c, and identify biomarkers that predict treatment response. Disclosure No

Eradication of Long-Term Vaginismus Type of Genito-Pelvic Pain/ Penetration Disorder by Treating with Dextroamphetamine Sulfate

There are many therapies for the vaginismus type of genito-pelvic pain/penetration disorder. However, as frequently found when there are multiple treatments for a given pathological disorder, not any of them are highly effective for this problem. It has been hypothesized that increased tissue permeability may be the etiologic factor causing inflammation in various tissues leading to a variety of different pain syndromes in various organ systems, including, but not limited to, the pelvis. Treatment with dextroamphetamine sulfate has resulted in significant palliation of the pain in the majority of cases treated. The hypothesized mechanism is that this amphetamine releases dopamine from sympathetic nerve fibers, which, in turn, diminishes excessive infiltration of irritants, which are the etiologic factor for the pain. Ideally, the best proof of efficacy for the treatment of this type of vaginismus/dyspareunia syndrome by dextroamphetamine sulfate would be to conduct a randomized prospective double-blinded multi-center study. However, because of the generic status of this drug, it is highly unlikely that any pharmaceutical company would fund such a study. The most practical feasible method to determine efficacy would be to try the drug on a very convincing cases of long-term severe vaginismus/dyspareunia syndrome that failed to respond to standard therapy. Indeed, such a case was found in a 32-year-old woman whose vaginismus was detected at puberty, that was associated with severe dyspareunia 10 years later, so that neither insertion of tampons nor intercourse had been possible. Within one month of treatment her vulvodynia/dyspareunia were eradicated. The relief has persisted for three years. Hopefully this case report may encourage treating physicians who treat a lot of similar cases to evaluate a large series or conduct a randomized study comparing amphetamine therapy vs. their best treatment option to date.

49. TINA: A novel Tampon INsertion Aid and Clinical Adjunct for Menstrual Management

49. TINA: A novel Tampon INsertion Aid and Clinical Adjunct for Menstrual Management

038 Vulvodynia and vaginal pain in pre pubertal girls

Background: Vulvodynia is a diagnosis of exclusion that can affect girls and women at any age. It causes a significant burden of disease and can negatively affect self-image and psychosexual development in girls and young women. Early recognition in children and young adults provides a chance to change the course of this potentially debilitating condition and thus minimize the long-term sequelae. Unfortunately, there is limited evidence available examining the presentation and treatment options in pre pubertal girls. Vaginal pain appears to be a very different entity and presents more commonly in pre pubertal patients. Presenting symptoms can be distressing and pose diagnostic dilemmas for the treating team. Conclusion: Vulvodynia has a peak incidence of 18-30 years however, pain on tampon insertion and first intercourse may unmask a condition that has been present for years prior. Urinary symptomatology commonly co-exists or precedes vulvodynia in the pediatric and adolescent population and we are slowly unravelling possible explanations for this. Whilst management strategies are extrapolated from data in adult cohorts, the vast majority of pre pubertal patients respond to medical management with neuromodulation, dedicated pain team input and physiotherapy.

A clinical briefing of (not so) rare chronic pain syndromes in gynecology: Interstitial cystitis and vulvodynia

Chronic pain has been currently defined as a pain that persists more than six weeks, despite of prescribed treatments. Interstitial cystitis or bladder pain syndrome is a chronic pain syndrome which implies urinary and pelvic pain, accompanied by voiding symptoms. The discomfort persists for more than six weeks and is apparently not related to any infectious or other identifiable causes. Patients complain of different voiding symptoms, which coexists with variable located pelvic pain. The voiding symptoms vary from urinary frequency, urgent need to void to pelvic pressure related filling to emptying of the urinary bladder. The unpleasant sensations described by the patients are: pain, pressure or discomfort and they are inevitably related to the urinary bladder. Many of these patients have associated pain syndromes, like: chronic fatigue syndrome, irritable bowel syndrome, fibromyalgia or other emotional conditions as depression and anxiety. Vulvodynia (or localized vulvar pain syndrome or vestibulodynia or vulvar vestibulitis) is defined as a vulvar pain that lasts for more than three months and has no identifiable cause and is considered a diagnostic of exclusion. Patients present with vulvar pain as major complaint. This pain is related to contact with the vestibular region of the vulva: during intercourse, prolonged sitting, bike riding, tight clothing, tampon insertion. Clinical diagnosis is based on several criteria: pain with vestibular localization (with or without clitoridean pain), provoked by pressure-point testing, with no other established cause and lasts for more than three months.

Vaginismus as a hidden problem: our case series

Vaginismus is a hidden problem because it is not discussed enough among professionals or inside the family. Consequently, the treatment of this problem is done secretly and by people who are not professionals, not to mention that they do not know what vaginismus really is. Vaginismus causes a woman’s pelvic floor muscles to contract at the attempt of vaginal penetration, making the vagina narrower and tighter. These muscle spasms are involuntary, and women with vaginismus often have trouble with any type of vaginal penetration, such as vaginal intercourse, tampon insertion, and gynecological exams. Penetration, when possible, is usually quite painful and causes great anxiety. For some women, intercourse is impossible. We present series of three cases treated in our Institute after a long-time treatment by others. All of them came et our Institute after a long period of time seeking alternative help and hiding the problem. Much work needs to be done on the sex education of the population in order to make them aware that they can discuss sexual problems freely. Physicians and other health personnel should also include a sexual history as an equal part of the medical examination.

Botulinum Toxin A as a Treatment for Provoked Vestibulodynia: A Randomized Controlled Trial.

To evaluate pain reduction after two injections of 50 units botulinum toxin A compared with placebo for provoked vestibulodynia. We conducted a double-blinded, placebo-controlled randomized trial of 50 units botulinum toxin A or placebo injected in the bulbocavernosus muscles twice, 3 months apart, in women with provoked vestibulodynia. Primary outcome was self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100). Secondary outcomes were pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress. A sample size of 38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76±31 SD). Between May 2016 and June 2018, 124 women with provoked vestibulodynia were assessed, and 88 were randomized to botulinum toxin A (BTA group, n=44) or placebo (placebo group, n=44). Primary outcome showed a lower but statistically nonsignificant pain rating by 7 VAS units (95% CI -15.0 to 0.4) in the BTA group compared with the placebo group. Secondary results showed a significant decrease in pain at weekly tampon insertion by 11 VAS units (95% CI -16.6 to 6.0) with botulinum toxin A injection. The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm Hg (95% CI -7.72 to -1.16) in the BTA group compared with the placebo group. No changes were observed for sexual function and distress, but there was a significant increase in women attempting vaginal intercourse in the BTA group (0.27, 95% CI 0.06-0.48). No severe adverse events were reported. Twice-repeated injections of 50 units of botulinum toxin A in women with provoked vestibulodynia did not reduce dyspareunia or pain at tampon use, but secondary outcomes suggested positive effects of the treatment. ClinicalTrials.gov, NCT02773641.

Association of characteristics of tampon use with menstrual toxic shock syndrome in France

SummaryBackgroundMenstrual tampons are widely used in western countries. Indirect evidence suggests that tampon misuse could be associated with an increased risk of menstrual toxic shock syndrome (MTSS). The aim of this study was to determine what characteristics of tampon use are associated with increased risk of menstrual toxic shock syndrome (MTSS).MethodsA nationwide, case-control study in France, was conducted with women that use tampons with MTSS diagnoses according to the CDC diagnostic criteria (n = 55, from January 2011, to December 2017) and a control group of women with no MTSS history (n = 126, from February to December 2017). Information regarding tampon use during a 6-month period was collected. Associations between tampon use and MTSS were assessed using logistic regression models stratified by residential area.FindingsCompared to controls, women diagnosed with MTSS more frequently reported maximum tampon wear of >6 h (62% vs. 41%; P = 0.02), overnight tampon use (77% vs. 54%; P = 0.006), and neither read nor followed tampon instructions in case of reading (65% vs. 42%; P = 0.006). In univariate analysis, MTSS risk was two-fold higher with tampon use for >6 consecutive hours (odds ratio, 2.3 [95% CI, 1.2–4.5]), and three-fold higher with tampon use during sleep for >8 h (odds ratio, 3.2 [95% CI, 1.4–7.7]). In multivariate logistic regression analysis, only maximum tampon use for >6 h (odds ratio, 2.03 [95% CI, 1.04–3.98]), and neither read nor followed the tampon instructions in case of reading (odds ratio, 2.25 [95% CI, 1.15–4.39]) were independently associated with MTSS.InterpretationOur study suggests that the risk of MTSS was associated with using tampons for more than 6 h, overnight tampon use during sleep, and neither read nor followed tampon insertion instructions in case of reading.FundingLABEX ECOFECT (ANR-11-LABX-0048) of Université de Lyon within the programme “Investissements d'Avenir” (ANR-11-IDEX-0007) operated by the French National Research Agency (ANR).

Cannabis and Vulvodynia Symptoms: A Preliminary Report.

Medical marijuana has a long history of use as an analgesic for chronic pain disorders, including dyspareunia (pain during intercourse), a hallmark of the rare chronic pain disorder vulvodynia. Many women’s health topics remain under investigated. Few studies address cannabis’s potential to treat vulvodynia symptoms despite their dramatic impact on quality of life. Women who had used cannabis and who reported experiencing vulvodynia symptoms (N = 38) completed an online survey assessing symptoms, expectancies regarding cannabis-associated relief from vulvodynia symptoms, cannabis use, and cannabis-related problems. Generally, women expected cannabis to have moderate to large effects on vulvodynia symptoms (d = .63-1.19). Nevertheless, women expected greater relief for burning/stabbing pain than for itching and pain associated with tampon insertion, as well greater relief for dyspareunia than for pain associated with tampon insertion. Those whose symptoms were worse expected more relief from cannabis treatment. Expectations of cannabis-induced relief did not increase frequency of use or problems. These data support the idea that further work is warranted, including placebo-controlled randomized clinical trials to rule out any placebo effects and identify potential adverse side effects from a cannabis treatment for vulvodynia.

Association of Characteristics of Tampon Use with Menstrual Toxic Shock Syndrome in France

Background: Menstrual tampons are widely used in western countries. Indirect evidence suggests that tampon misuse could be associated with an increased risk of menstrual toxic shock syndrome (MTSS). The aim of the study was to determine tampon use associated with increased risk of menstrual toxic shock syndrome (MTSS). Methods: A nationwide, case-control study in France, was conducted with women that use tampon with MTSS diagnoses according to the CDC diagnostic criteria (n=55, from January 2011, to December 2017) and controls women with no MTSS history (n=126, from February to December 2017). Information regarding tampon use during a 6-month period was collected. Associations between tampon use and MTSS were assessed using logistic regression models stratified by residential area. Findings: Compared to controls, cases more frequently reported maximum tampon wear of >6 hours (62% vs. 41%; P=0.02), overnight tampon use (77% vs. 54%; P=0.006), and not having read and followed tampon instructions (65% vs. 42%; P=0.006). In univariate analysis, MTSS risk was two-fold higher with tampon use for >6 consecutive hours (odds ratio, 2.3 [95% CI, 1.2–4.5]), and three-fold higher with tampon use during sleep for >8 hours (odds ratio, 3.2 [95% CI, 1.4–7.7]). In multivariate logistic regression analysis, only maximum tampon use for >6 hours (odds ratio, 2.03 [95% CI, 1.04–3.98]), and not reading and following the tampon instructions (odds ratio, 2.25 [95% CI, 1.15–4.39]) were independent associated with MTSS. Interpretation: Our study indicates suggests that risk of MTSS was associated with women who used tampons for more than 6 hours, overnight tampon during sleep, and who reported not reading and following tampon insertion instructions. Funding Statement: This work was supported by the LABEX ECOFECT (ANR-11-LABX-0048) of Universite de Lyon within the programme Investissements d'Avenir (ANR-11-IDEX-0007) operated by the French National Research Agency (ANR). Declaration of Interests: The authors declare no competing interest. Ethics Approval Statement: This study was reviewed and accepted by the Ethics Committee (CPP Sud Est IV, Centre Leon Berard, Lyon, France, N° L16-176). Written consent was obtained from all participants, or from the parents/guardians of participants under 18 years of age.

Hysteroscopic Resection of a Complete Uterine and Vaginal Septum Under Laparoscopic Ultrasound Guidance

Video Objective The aim of this video is to demonstrate the use of laparoscopic ultrasound guidance during hysteroscopic resection of a congenital uterine and vaginal septum. Setting Our patient is a 20 year old G0 female who presented for difficulty with tampon insertion and removal as well as painful intercourse. On physical exam, the patient was noted to have a complete, non-obstructing longitudinal vaginal septum with two separate normal cervices. MRI of the abdomen and pelvis showed a complete septate uterus, two cervices, and two normal kidneys. Interventions This video shows the simultaneous use of hysteroscopy and laparoscopic ultrasound to safely and successfully resect the uterine and vaginal septum. Conclusion The goal is to encourage use of this technique during similar procedures for patients with mullerian duct anomalies desiring surgical correction.

Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial.

To evaluate whether extended-release gabapentin is more effective than placebo among women with vulvodynia. In a multicenter double-blind, placebo-controlled randomized crossover trial, gabapentin (1,200-3,000 mg/d) was compared with a placebo. The primary outcome was mean pain intensity (0, no pain at all to 10, worst pain ever) on the tampon test (a standardized tampon insertion and removal test used as a surrogate marker for dyspareunia) during the last 7 days of the maintenance phase. Secondary outcomes included sexual intercourse pain and daily pain. A sample size of 53 provided 90% power to detect a 1-point reduction on the tampon test (.05 level, two-sided) between the two treatment phases. From August 2012 to January 2016, 230 women were screened at three academic institutions and 89 (mean age 37 years; 65% black) were randomized: 45 to gabapentin first and then placebo and 44 to placebo first and then gabapentin. Tampon test pain with gabapentin was not different compared with the placebo (adjusted mean 4.0, 95% CI 3.0-4.9 vs 4.3, 95% CI 3.4-5.2, difference -0.3, 95% CI -0.7 to 0.0; P=.07). Gabapentin also did not improve pain over placebo for sexual intercourse pain (adjusted mean 3.9, 95% CI 2.4-5.3 vs 4.0, 95% CI 2.5-5.4, difference -0.1, 95% CI -0.9 to 0.6; P=.76) and daily pain (adjusted mean 2.7, 95% CI 1.8-3.6 vs 2.9, 95% CI 2.0-3.8, difference -0.2, 95% CI -0.5 to -0.2; P=.36). Subset analyses found that longer pain duration and oral contraceptive nonuse were associated with minimal improvement in tampon test pain with gabapentin. In this cohort, extended-release gabapentin, as compared with a placebo, did not reduce tampon test pain. These data do not support the recommendation of gabapentin alone as treatment for vulvodynia. ClinicalTrials.gov, NCT01301001.

Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia—A Randomized, Placebo-Controlled Pilot Trial

BackgroundLow-level laser therapy (LLLT) is an emerging medical technology in which non-thermal laser irradiation is applied to treat pain. Because LLLT has been found effective in treating various pain syndromes without known side effects, we conducted a study evaluating the effect of LLLT on provoked vestibulodynia (PVD), a complex sexual pain disorder characterized by pain confined to the vulvar vestibule in response to contact or pressure. AimTo investigate the effectiveness of LLLT for PVD in a randomized, placebo-controlled, double-blinded trial. MethodsPatients with PVD were randomly assigned to receive treatment with LLLT or sham treatment. Patients were treated twice weekly for 6 weeks, for a total of 12 LLLT or placebo sessions. Patients who showed improvement after LLLT were followed for 1 year by clinical pain report and Q-tip examination. OutcomesChange in pain scores obtained in response to the Q-tip test, clinical pain report, visual analog scale score, pain with tampon insertion, daily pain intensity, intercourse pain intensity, frequency of intercourse, and a battery of quality-of-life measures. ResultsThirty-four patients with PVD participated, 18 received LLLT and 16 received placebo. In the clinical pain report at study completion, 14 of 18 patients (78%) receiving LLLT reported improvement compared with 7 of 16 (44%) in the placebo group (P = .042). This effect was not apparent in other outcome measurements. None of the patients reported side effects during the study. At 1-year follow-up, eight patients (57%) reported lasting improvement. Clinical ImplicationsLarger studies with various treatment protocols are needed to define which patients can benefit from LLLT therapy. Strengths and LimitationsStrengths include a placebo-controlled, double-blinded design, measurement of a large number of multidimensional end points, and a follow-up period of 1 year. Limitations include the small number of patients recruited, no improvement in measurable parameters, a high improvement rate in the placebo group, the absence of use of validated questionnaires, and the lack of evaluation of psychological and interpersonal factors that might have influenced the results. ConclusionsGiven the results of this pilot study, LLLT cannot currently be recommended as a treatment for PVD. Further studies with a larger population, various treatment protocols, and evaluation of LLLT in different subgroups of PVD are needed to define which patients can benefit from this therapy.Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia—A Randomized, Placebo-Controlled Pilot Trial. J Sex Med 2017;14:1403–1411.

Vulvar Pain—Associations Between First-Time Vaginal Intercourse, Tampon Insertion, and Later Experiences of Pain

This study examines associations between the first experience of vaginal intercourse/tampon insertion and later experiences of vulvar pain. The study is based on questionnaire data from 1,259 Swedish female senior high-school students, aged 18 to 22 years old. Of these, 592 women reported present vulvar pain. Present vulvar pain was associated with first-time experiences of vaginal intercourse (pain, negative experience, against will) and with pain at tampon insertion. First-time experiences were also related to temporal aspects of present vulvar pain during vaginal intercourse (at the beginning, after a while during, and after). Implications of first-time experiences of vaginal intercourse for future symptoms of vulvar pain are discussed.

Pain Rating in Women with Provoked Vestibulodynia: Evaluating Influence of Race.

Chronic pain may be perceived differently according to gender and race, which may affect physical health and psychological wellbeing. We evaluated daily pain ratings in black women as compared to white women with provoked vestibulodynia (PVD). Seventy-one women (44 black, 27 white) rated pain severity with tampon insertion and sexual intercourse and recorded daily vulvar pain level on a visual analogue scale (0 = no pain to 10 = worst pain imaginable). In addition, they completed the Brief Pain Inventory (BPI) Interference Scale and Hamilton Anxiety Depression Scale (HADS). Multivariate analysis was performed to determine the effect of race on pain intensity after adjusting for functional impairment, affective distress and demographic characteristics. Pain ratings from tampon insertion (6.37 ± 1.89 vs. 5.61 ± 1.98, p = .12) and sexual intercourse (6.28 ± 2.11 vs. 5.29 ± 2.50, p = 0.24) were similar, but daily vulvar pain (4.57 ± 2.27 vs 2.74 ± 2.43, p = <.01) was significantly higher in black women. BPI-interference scores were associated with small, but significant increases in tampon insertion pain (p = <.01, beta = .06 units) and daily pain (p < .01, beta = .10 units) and to a lesser degree with sexual intercourse pain when corrected for multiple comparisons (p = .05, beta = .06 units). Race had no effect on pain after adjusting for other variables. While race was associated with functional impairment, after accounting for this, race was not associated with level of vulvar pain with PVD.

A Practical Solution for Dyspareunia in Breast Cancer Survivors: A Randomized Controlled Trial.

Dyspareunia is common in breast cancer survivors because of low estrogen. This study explored whether dyspareunia is introital pain, preventable with analgesic liquid. In a randomized, controlled, double-blind trial, estrogen-deficient breast cancer survivors with severe penetrative dyspareunia applied either saline or 4% aqueous lidocaine to the vulvar vestibule for 3 minutes before vaginal penetration. After a 1-month blinded trial of patient-assessed twice-per-week tampon insertion or intercourse, all patients received lidocaine for 2 months in an open-label trial. The primary outcome was patient-related assessment of penetration pain on a scale of zero to 10. Secondary outcomes were sexual distress (Female Sexual Distress Scale), sexual function (Sexual Function Questionnaire), and resumption of intercourse. Comparisons were made with the Mann-Whitney U and Wilcoxon signed rank test with significance set at P < .05. In all, 46 patients, screened to exclude those with pelvic muscle and organ pain, uniformly had clinical evidence of severe vulvovaginal atrophy, dyspareunia (median pain score, 8 of 10; interquartile range [IQR], 7 to 9), increased sexual distress scores (median, 30.5; IQR, 23 to 37; abnormal, > 11), and abnormal sexual function. Users of lidocaine reported less pain during intercourse in the blinded phase (median score of 1.0 compared with saline score of 5.3; P = .007). After open-label lidocaine use, 37 (90%) of 41 reported comfortable penetration. Sexual distress decreased (median score, 14; IQR, 3 to 20; P < .001), and sexual function improved in all but one domain. Of 20 prior abstainers from intercourse who completed the study, 17 (85%) had resumed comfortable penetrative intimacy. No partners reported penile numbness. Breast cancer survivors with menopausal dyspareunia can have comfortable intercourse after applying liquid lidocaine compresses to the vulvar vestibule before penetration.