Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial.

BACKGROUND: Endometriosis-related pain encompassing dysmenorrhea, dyspareunia, and chronic pelvic pain, reduces the quality of life in premenopausal women. Although treatment options for endometriosis alleviate this pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. The Angel Touch device (AT-04) is a portable magnetic fields irradiation device that incorporates a combination of mixed alternative magnetic fields at 2 kHz and 83.3 MHz. A phase III trial confirmed the efficacy and safety of AT-02, a prototype of AT-04, for pain relief in patients with fibromyalgia. METHODS: This is a phase III, multicenter, prospective, randomized, sham device-controlled, double-blind, parallel study. The participants will be premenopausal women aged > 18 years who have endometriosis-related pain with at least moderate severity. Considering dropouts, 50 participants have been deemed appropriate. Eligible women will be centrally registered, and the data center will randomly allocate them in a 1:1 ratio to the intervention and control groups. Women in the intervention group will receive electromagnetic wave irradiation generated by AT-04 and those who in the control group will wear a sham device for 16 weeks, and both groups will wear AT-04 for another 4 weeks. The primary outcome measure is the change in the Numeric Rating Scale score at 16 weeks compared with the baseline. Secondary outcome measures are efficacy for pelvic pain including dysmenorrhea and non-menstrual pain, and chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia, and improvement of quality of life during the study period. Safety will be evaluated by device defects and the frequency of adverse events. The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act and relevant notifications. DISCUSSION: This study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age. Trial registration number Japan Registry of Clinical Trials (jRCTs032230278).

Endometriosis is a chronic inflammatory disorder that negatively impacts reproductive health via endometriosis-related pain, infertility, and endometriosis-associated ovarian cancer. Although current therapeutic options for endometriosis are effective for the endometriosis-related pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. This is the first randomized controlled trial to investigate the efficacy and safety of a novel portable pain management device, AT-04, that incorporates a combination of mixed alternating magnetic fields, for endometriosis-related pain. This is a multicenter, prospective, sham device-controlled, double-blind, parallel study. Enrolled women will have undergone standard hormonal treatment for endometriosis at baseline, and this allows for assessing whether the device remains effective when used in conjunction with existing treatment methods. The study also will explore the impact of AT-04 on reducing the size of ovarian endometriotic cysts that reflect the activity of endometriosis. The study reflects the strong desire by physicians to liberate women from the unbearable pain associated with endometriosis. The sole efficacy of AT-04 in treating endometriosis-related pain is difficult to evaluate as there is a possibility that menstrual cycles may influence the assessment of pain and quality of life. However, the study findings regarding the effectiveness of AT-04 for the treatment of endometriosis-related pain may benefit women with endometriosis who have pain that is not effectively relieved by other treatments. Consequently, it may contribute to the improvement of reproductive health within society.

Diagnosis and management of complications following pelvic organ prolapse surgery using a synthetic mesh: French national guidelines for clinical practice.

Complications associated with pelvic organ prolapse (POP) surgery using a synthetic non-absorbable mesh are uncommon (<5%) but may be severe and may hugely diminish the quality of life of some women. In drawing up these multidisciplinary clinical practice recommendations, the French National Authority for Health (Haute Autorité de santé, HAS) conducted an exhaustive review of the literature concerning the diagnosis, prevention, and management of complications associated with POP surgery using a synthetic mesh. Each recommendation for practice was allocated a grade (A,B or C; or expert opinion (EO)), which depends on the level of evidence (clinical practice guidelines). PREOPERATIVE PATIENTS' INFORMATION: Each patient must be informed concerning the risks associated with POP surgery (EO). HEMORRHAGE, HEMATOMA: Vaginal infiltration using a vasoconstrictive solution is not recommended during POP surgery by the vaginal route (grade C). The placement of vaginal packing is not recommended following POP surgery by the vaginal route (grade C). During laparoscopic sacral colpopexy, when the promontory seems highly dangerous or when severe adhesions prevent access to the anterior vertebral ligament, alternative surgical techniques should be discussed per operatively, including colpopexy by lateral mesh laparoscopic suspension, uterosacral ligament suspension, open abdominal mesh surgery, or surgery by the vaginal route (EO). BLADDER INJURY: When a bladder injury is diagnosed, bladder repair by suturing is recommended, using a slow resorption suture thread, plus monitoring of the permeability of the ureters (before and after bladder repair) when the injury is located at the level of the trigone (EO). When a bladder injury is diagnosed, after bladder repair, a prosthetic mesh (polypropylene or polyester material) can be placed between the repaired bladder and the vagina, if the quality of the suturing is good. The recommended duration of bladder catheterization following bladder repair in this context of POP mesh surgery is from 5 to 10 days (EO). URETER INJURY: After ureteral repair, it is possible to continue sacral colpopexy and place the mesh if it is located away from the ureteral repair (EO). RECTAL INJURY: Regardless of the approach, when a rectal injury occurs, a posterior mesh should not be placed between the rectum and the vagina wall (EO). Concerning the anterior mesh, it is recommended to use a macroporous monofilament polypropylene mesh (EO). A polyester mesh is not recommended in this situation (EO). VAGINAL WALL INJURY: After vaginal wall repair, an anterior or a posterior microporous polypropylene mesh can be placed, if the quality of the repair is found to be satisfactory (EO). A polyester mesh should not be used after vaginal wall repair (EO). MESH INFECTION (ABSCESS, CELLULITIS, SPONDYLODISCITIS): Regardless of the surgical approach, intravenous antibiotic prophylaxis is recommended (aminopenicillin + beta-lactamase inhibitor: 30 min before skin incision +/- repeated after 2 h if surgery lasts longer) (EO). When spondylodiscitis is diagnosed following sacral colpopexy, treatment should be discussed by a multidisciplinary group, including especially spine specialists (rheumatologists, orthopedists, neurosurgeons) and infectious disease specialists (EO). When a pelvic abscess occurs following synthetic mesh sacral colpopexy, it is recommended to carry out complete mesh removal as soon as possible, combined with collection of intraoperative bacteriological samples, drainage of the collection and targeted antibiotic therapy (EO). Non-surgical conservative management with antibiotic therapy may be an option (EO) in certain conditions (absence of signs of sepsis, macroporous monofilament polypropylene type 1 mesh, prior microbiological documentation and multidisciplinary consultation for the choice of type and duration of antibiotic therapy), associated with close monitoring of the patient. BOWEL OCCLUSION RELATED TO NON-CLOSURE OF THE PERITONEUM: Peritoneal closure is recommended after placement of a synthetic mesh by the abdominal approach (EO). URINARY RETENTION: Preoperative urodynamics is recommended in women presenting with urinary symptoms (bladder outlet obstruction symptoms, overactive bladder syndrome or incontinence) (EO). It is recommended to remove the bladder catheter at the end of the procedure or within 48 h after POP surgery (grade B). Bladder emptying and post-void residual should be checked following POP surgery, before discharge (EO). When postoperative urine retention occurs after POP surgery, it is recommended to carry out indwelling catheterization and to prefer intermittent self-catheterization (EO). POSTOPERATIVE PAIN: Before POP surgery, the patient should be asked about risk factors for prolonged and chronic postoperative pain (pain sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Concerning the prevention of postoperative pain, it is recommended to carry out a pre-, per- and postoperative multimodal pain treatment (grade B). The use of ketamine intraoperatively is recommended for the prevention of chronic postoperative pelvic pain, especially for patients with risk factors (preoperative painful sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Postoperative prescription of opioids should be limited in quantity and duration (grade C). When acute neuropathic pain (sciatalgia or pudendal neuralgia) resistant to level I and II analgesics occurs following sacrospinous fixation, a reintervention is recommended for suspension suture removal (EO). When chronic postoperative pain occurs after POP surgery, it is recommended to systematically seek arguments in favor of neuropathic pain with the DN4 questionnaire (EO). When chronic postoperative pelvic pain occurs after POP surgery, central sensitization should be identified since it requires a consultation in a chronic pain department (EO). Concerning myofascial pain syndrome (clinical pain condition associated with increased muscle tension caused by myofascial trigger points), when chronic postoperative pain occurs after POP surgery, it is recommended to examine the levator ani, piriformis and obturator internus muscles, so as to identify trigger points on the pathway of the synthetic mesh (EO). Pelvic floor muscle training with muscle relaxation is recommended when myofascial pain syndrome is associated with chronic postoperative pain following POP surgery (EO). After failure of pelvic floor muscle training (3 months), it is recommended to discuss surgical removal of the synthetic mesh, during a multidisciplinary discussion group meeting (EO). Partial removal of synthetic mesh is indicated when a trigger point is located on the pathway of the mesh (EO). Total removal of synthetic mesh should be discussed during a multidisciplinary discussion group meeting when diffuse (no trigger point) chronic postoperative pain occurs following POP surgery, with or without central sensitization or neuropathic pain syndromes (EO). POSTOPERATIVE DYSPAREUNIA: When de novo postoperative dyspareunia occurs after POP surgery, surgical removal of the mesh should be discussed (EO). VAGINAL MESH EXPOSURE: To reduce the risk of vaginal mesh exposure, when hysterectomy is required during sacral colpopexy, subtotal hysterectomy is recommended (grade C). When asymptomatic vaginal macroporous monofilament polypropylene mesh exposure occurs, systematic imaging is not recommended. When vaginal polyester mesh exposure occurs, pelvic +/- lumbar MRI (EO) should be used to look for an abscess or spondylodiscitis, given the greater risk of infection associated with this type of material. When asymptomatic vaginal mesh exposure of less than 1 cm2 occurs in a woman with no sexual intercourse, the patient should be offered observation (no treatment) or local estrogen therapy (EO). However, if the patient wishes, partial excision of the mesh can be offered. When asymptomatic vaginal mesh exposure of more than 1 cm2 occurs or if the woman has sexual intercourse, or if it is a polyester prosthesis, partial mesh excision, either immediately or after local estrogen therapy, should be offered (EO). When symptomatic vaginal mesh exposure occurs, but without infectious complications, surgical removal of the exposed part of the mesh by the vaginal route is recommended (EO), and not systematic complete excision of the mesh. Following sacral colpopexy, complete removal of the mesh (by laparoscopy or laparotomy) is only required in the presence of an abscess or spondylodiscitis (EO). When vaginal mesh exposure recurs after a first reoperation, the patient should be treated by an experienced team specialized in this type of complication (EO). SUTURE THREAD VAGINAL EXPOSURE: For women presenting with vaginal exposure to non-absorbable suture thread following POP surgery with mesh reinforcement, the suture thread should be removed by the vaginal route (EO). Removal of the surrounding mesh is only recommended when vaginal mesh exposure or associated abscess is diagnosed. BLADDER AND URETERAL MESH EXPOSURE: When bladder mesh exposure occurs, removal of the exposed part of the mesh is recommended (grade B). Both alternatives (total or partial mesh removal) should be discussed with the patient and should be debated during a multidisciplinary discussion group meeting (EO).

Effectiveness of Two Transcutaneous Electrical Nerve Stimulation (TENS) Protocols in Women with Provoked Vestibulodynia: A Randomized Controlled Trial.

BACKGROUND: Vestibulodynia (VBD) is the most common form of vulvodynia. Because VBD is a pain disorder, transcutaneous electrical nerve stimulation (TENS) can be used as treatment. This study aims to evaluate the effects of two-parameter combinations (frequency and pulse duration) of TENS in reducing pain intensity and dyspareunia in VBD. METHODS: A randomized, double-blind, controlled trial was conducted to study the effect of two different electrical stimulation treatment regimens on women with VBD receiving domiciliary TENS. Outcomes were the mean change from baseline at 60 and 120 days of burning/pain and dyspareunia (VAS), Vulvar Pain Functional Questionnaire (V-Q), Female Sexual Functioning Index (FSFI) and vaginal electromyography measurements. RESULTS: A total of 78 subjects, 39 in each group, completed the trial. Patients in Groups 1 and 2 received a mean of 46.9 and 48.4 TENS sessions. By day 120, there was a 38.2% reduction in the burning/pain and a 52.1% reduction in the dyspareunia VAS scores in Group 1, as compared to 21.3% (p = 0.003) and 23.1% in Group 2 (p = 0.01), respectively. FSFI, V-Q, and muscle-strength measures also improved but were not statistically significant. CONCLUSIONS: Our findings showed the potential of TENS in the treatment of VBD.

Three-year Follow-up of a Single Incision Sling Procedure Performed Under Local Anesthesia in an Office Setting.

OBJECTIVE: To assess the 3-year success of placing a single-incision midurethral sling (SIMS) using the Dynamic Intraoperative Standing Sling Technique (DISST) in an office setting under local anesthesia. METHODS: This is a prospective case series of 20 women who underwent in-office SIMS procedure by the DISST from July 2019 to February 2020. This is an extension of our pilot study (11) and all 20 patients were evaluated at a mean follow-up of 34.3months. Success was defined as a composite score of objective success (negative standing cough test at bladder fullness), subjective success based on the modified PGI-I score of "very much better" or "much better," and no retreatment for stress urinary incontinence. Secondary objectives were adverse events, de novo overactivity of the bladder, recurrent urinary tract infections, voiding dysfunction, pain/dyspareunia, and influence on sexual function. RESULTS: The composite success rate was 95% (95% CI [75.1, 99.9]) at the 36-month follow-up. The significant improvement in MESA scores was maintained over the study period. There were no cases of de novo urgency, mesh exposure, postop voiding dysfunction or recurrent urinary tract infections. There were no cases of de novo dyspareunia. CONCLUSION: SIMS placed by the DISST technique under local anesthesia in an office setting has shown sustained efficacy over a 3-year period with no decrease in cure. Subjects remained dry and reported excellent improvement in symptoms and quality of life at the 36-month follow-up visit.

Antenatal perineal massage - risk of perineal injuries, pain, urinary incontinence and dyspereunia - a systematic review.

BACKGROUND: Natural childbirth is associated with the risk of damage to the perineum - a tears or a episiotomy. Adequate preparation of the woman for childbirth is essential to minimize the occurrence of perinatal injuries. AIM: The aim of the review is to assess and analyze the impact of APM (antental perineal massage) on perinatal perineal injuries and the development of pelvic pain and other complications in postpartum women, such as dyspareunia, urinary (UI), gas (GI), and fecal incontinence (FI). METHODS: PubMed, Web of Science, Scopus and Embase were searched. Three authors independently searched databases and selected articles for inclusion and exclusion criteria. Next one author did Risk of Bias 2 and ROBINS 1 analyze. FINDINGS: Of 711 articles, 18 publications were left for the review. All 18 studies examined the risk of perineal injuries (tearing and episiotomy), 7 pain in postpartum period, 6 postpartum urinary, gas/fecal incontinence and 2 described dyspareunia. Most authors described APM from 34 weeks of pregnancy until delivery. There were different techniques and times for doing APM procedures. DISCUSSION: APM has many benefits for women during labor and the postpartum period (e.g. lower rate of perineal injuries and pain). However, it can be observed that individual publications differ from each other in the time of massage, the period and frequency of its performance, the form of obtaining instruction and control of patients. These components may affect the results obtained. CONCLUSION: APM can protects the perineum from injuries during labor. It also reduces risk of fecal and gas incontinence in postpartum period.

Effectiveness of physical therapy interventions in women with dyspareunia: a systematic review and meta-analysis.

BACKGROUND: Dyspareunia is defined as the occurrence of pain during or after sexual intercourse, which directly affects physical, sexual, and mental health. This condition can lead to depression, anxiety, and low self-esteem in women who experience it. OBJECTIVES: The aim of this research was to evaluate the effectiveness of physical therapy interventions for the treatment of female dyspareunia. DESIGN: A systematic review and meta-analysis was conducted. METHOD: Search of publications was conducted in Scopus, Medline, Pubmed, Cinahl and Web of Science. Treatment effects were defined as standardized mean difference and their 95% confidence intervals. Statistical heterogeneity was assessed using Crohan's Q test and quantified using the I2 index. RESULTS: Of the 19 articles selected, six applied multimodal physiotherapy treatments; five, electrotherapy; three, Thiele's massage; two, interdisciplinary interventions or pelvic floor muscle training; and one, extracorporeal shockwave therapy. The meta-analysis showed significant results for the variables pain and quality of life with the interventions based on electrotherapy and electrotherapy combined with pelvic floor muscle training. These interventions did not show significant results for the improvement of sexual function. CONCLUSIONS: Physiotherapy techniques are effective and procedures have been identified with reliable results in improving pain and quality of life in patients with dyspareunia. One of the most important aspects is the strengthening of the perineal musculature and the application of Transcutaneous Electrical Nerve Stimulation. Furthermore, manual trigger point release therapy and Thiele massage, optimize and guarantee the reduction of pain intensity. PROSPERO REGISTRATION: CRD42021236155.

The effect of nettle vaginal cream on subjective symptoms of vaginal atrophy in postmenopausal women.

BACKGROUND AND OBJECTIVE: Vaginal atrophy is a condition where the vaginal epithelium gets thinner and includes symptoms, such as vaginal dryness, abnormal vaginal discharge, vaginal bleeding, dyspareunia, and sexual problems. Hormone therapy is associated with some problems and some women prefer herbal medicine to reduce vaginal atrophy. Considering the phytoestrogenic compounds present in the nettle, this study aimed to investigate the effect of the nettle vaginal cream on subjective symptoms of vaginal atrophy in postmenopausal women. MATERIALS AND METHODS: This triple-blind randomized placebo-controlled clinical trial study was conducted on 84 eligible postmenopausal women aged 45-60 years, who referred to comprehensive health service centers in Aliabad Katul in 2021-2022. Women eligible for the study received 5% nettle vaginal cream and placebo for 8 weeks. Subjective symptoms of vaginal atrophy were assessed before, four and eight weeks after the intervention. Data collection tools included a checklist for research unit selection, individual and midwifery characteristics questionnaire, vaginal assessment scale (VAS), vaginal pH, laboratory results of the vaginal maturation value (VMV). Data analysis was performed using SPSS software (version 21) and independent t-test, Mann-Whitney, chi-square, Two-way analysis of variance and analysis of covariance. P value less than 0.05 was considered significant. RESULTS: Subjective symptoms of vaginal atrophy decreased significantly after the intervention compared to before the intervention in both the nettle and placebo groups (p < 0.001), but in the comparison between groups four weeks and eight weeks after the intervention, the subjective symptoms of vaginal atrophy in nettle group decreased significantly (p < 0.001). In the nettle group, the scores of vaginal burning, vaginal dryness, vaginal itching and dyspareunia significantly improved after the intervention compared to before the intervention (p < 0.001). Also, in the nettle group compared to the placebo group, after the intervention, vaginal burning and vaginal dryness score (p < 0.001) and vaginal itching score (0.004) improved significantly. CONCLUSION: Based on the results of the present study, Nettle vaginal cream reduced subjective symptoms of vaginal atrophy, including vaginal burning, vaginal dryness, vaginal itching, and dyspareunia in postmenopausal women, so it is a cost-effective, available and do not have the side effects product that can be useful for menopausal women.

The effects of sexual counseling and pelvic floor relaxation on sexual functions in women receiving vaginismus treatment: a randomized controlled study.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to determine the effects of sexual counseling and pelvic floor relaxation on sexual functions in women receiving vaginismus treatment. METHODS: A total of 34 women at the vaginismus treatment stage, including 17 in the experiment group and 17 in the control group, were included in the study with a randomized controlled design. In addition to the routine treatment protocol, women in the experiment group were provided with pelvic relaxation and sexual counseling based on the Information, Motivation, Behavior (IMB) model consisting of four sessions. The control group received the routine treatment protocol. The assessments were made at the 3rd week and 2nd month after coitus. The women filled out an Information Form, the validated Female Sexual Function Index (FSFI), and the Vaginal Penetration Cognition Questionnaire (VPCQ). RESULTS: The mean age of the women was 27.59±5.32, and their mean duration of marriage/relationship was 33.44±12.11 months. After the treatment statistically significant increases were observed in the total FSFI scores and the desire, arousal, and pain dimension scores of the experiment group in comparison with the control group (p<0.05). In the VPCQ total scores, there was a significant reduction in the experiment group in comparison with the control group and after the treatment in comparison with before the treatment (p<0.01). CONCLUSIONS: The sexual counseling based on the IMB model and pelvic relaxation interventions provided to the women who were receiving vaginismus treatment affected their sexual function positively. It may be recommended to conduct comparative studies with a broader sample and different models.

Secondary dysmenorrhea and dyspareunia associated with pelvic girdle dysfunction: A case report and review of literature.

Secondary dysmenorrhea is frequently associated with dyspareunia. When the diagnostic workup is negative, its clinical management could be complex and a cause for concerned for the patient. We reported a case of a young woman who suffered from dyspareunia, dysmenorrhea and chronic pelvic pain. After symptoms progression and pharmacological therapy unresponsiveness, the gynaecologist referred the patient to an osteopath for the functional evaluation of the abdominal pevic area. The examination revealed the presence of pelvic, lumbosacral, and sacrococcygeal dysfunctions which, once treated, significatively reduced the severity of dysmenorrhea and dyspareunia. A multidisciplinary approach might be considered in case of suspected functional impairment. This should be carefully evaluated, considering the previous trauma history and the somatic dysfunctions on abdominal-pelvic fascia.

Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study.

OBJECTIVE: The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18ß-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks. STUDY DESIGN: Postmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days. MAIN OUTCOME MEASURE: The Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function. RESULTS: Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001). CONCLUSIONS: The present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance. This trial is registered prospectively with the Clinical Trials Registry - India, number CTRI/2019/05/01911.

The effect of vitamin D supplementation on clinical symptoms and metabolic profiles in patients with endometriosis.

BACKGROUND: To our knowledge, data on the effects of vitamin D supplementation on clinical symptoms and metabolic profiles in patients with endometriosis are limited. This study was conducted to determine the effects of vitamin D supplementation on clinical symptoms and metabolic profiles in patients with endometriosis. METHODS: The current randomized, double-blind, placebo-controlled trial was conducted among 60 patients (aged 18-40 years old) with endometriosis. Participants were randomly allocated into two groups (30 participants each group) to receive either 50,000 IU vitamin D or placebo each 2 weeks for 12 weeks. RESULTS: Vitamin D supplementation significantly decreased pelvic pain (ß - 1.12; 95% CI, -2.1, -0.09; p=.03) and total-/HDL-cholesterol ratio (ß - 0.29; 95% CI, -0.57, -0.008; p=.04) compared with the placebo. Moreover, vitamin D intake led to a significant reduction in high-sensitivity C-reactive protein (hs-CRP) (ß - 0.64 mg/L; 95% CI, -0.97, -0.30; p<.001) and a significant increase in total antioxidant capacity (TAC) (ß 47.54 mmol/L; 95% CI, 19.98, 75.11; p=.001) compared with the placebo. CONCLUSIONS: Overall, our study demonstrated that vitamin D intake in patients with endometriosis resulted in a significant improvement of pelvic pain, total-/HDL-cholesterol ratio, hs-CRP and TAC levels, but did not affect other clinical symptoms and metabolic profiles.

Interventions and Practice Implications for the Management of Endometriosis.

Endometriosis is a chronic inflammatory disorder in which endometrial tissue grows outside the uterus. Although the disorder is currently estimated to affect approximately 10% of reproductive-age women, there is evidence to suggest that many women remain undiagnosed. Women with endometriosis may experience pain, abnormal menstruation, gastrointestinal symptoms, chronic fatigue, and infertility. Because of the varying symptomatology, the disorder may also foster negative psychosocial outcomes and decrease overall quality of life. Because there is no known cure, an effective patient-clinician relationship is crucial to successful long-term management of the condition. Several interventions exist, including nonsurgical and surgical management. Here, we provide an overview of endometriosis and current treatment options, as well as evidence-based practice implications for nurses who work with women who have endometriosis.

Hormonal treatment isolated versus hormonal treatment associated with electrotherapy for pelvic pain control in deep endometriosis: Randomized clinical trial.

OBJECTIVE: The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard hormonal treatment alone for deep infiltrative endometriosis (DIE). STUDY DESIGN: Multicentre randomized clinical trial. We included a hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up. The primary measurement was chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia. The secondary outcomes were the quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI). RESULTS: CPP relief was observed only in the electrotherapy group (pre:7.11 ± 2.40, post:4.55 ± 3.08, p < 0.001). In terms of deep dyspareunia, improvements were observed for both groups (electrotherapy pre:2.02 ± 0.54-1.36 ± 0.96, p < 0.001; control pre:1.95 ± 0.86-1.68 ± 0.82, p = 0.006). Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups. Regarding sexual function, there was a statistically significant improvement in the FSFI score for the electrotherapy group (p < 0.001), with an increase in the scores for lubrication and pain domains (p = 0.013 and p < 0.001). CONCLUSIONS: Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing benefits in the reduction of CPP and deep dyspareunia and improving patient's quality of life and sexual function.

Effectiveness of the integration of quercetin, turmeric, and N-acetylcysteine in reducing inflammation and pain associated with endometriosis. In-vitro and in-vivo studies.

BACKGROUND: to evaluate the efficacy of oral administration of a novel composition composed of quercetin, curcumin, acetylcysteine in reducing pain in women affected by endometriosis, through the reduction of the inflammatory-hyperproliferative component of the ectopic endometrial tissue. METHODS: Thirty-three women with clinical diagnosis of endometriosis from at least 3 months have been enrolled. Patients have been treated daily with 200 mg of quercetin, 210 mg of dry extract of Curcuma longa (titrated at 95% in curcuminoids) and 150 mg of acetylcysteine (1 tablet of ALLIENDO®) for 2 months. The overall symptomatology with specific reference to dysmenorrhea, pelvic pain and dyspareunia, together with the frequency of nonsteroidal anti-inflammatory drugs (NSAID) drugs assumption have been evaluated at the beginning and at the end of the treatment. RESULTS: Overall, the results collected at the end of the treatment according to the parameters evaluated and above mentioned on the 33 patients enrolled, show a significative improvement in the reduction of pain symptoms associated to endometriosis (P<0.001 for dysmenorrhea, pelvic pain and dyspareunia). The use of NSAIDs together with an overall reduction of their dosage and time of assumption has been reduced as well. No significative side effects have been observed. CONCLUSIONS: The aforementioned results suggest that administration of the composition described can represent a valuable adjuvant treatment in the reduction of pain symptomatology associated to endometriosis, triggered by inflammatory cascade and hyperproliferation of ectopic tissue.

[Effectiveness of multimodal rehabilitation (biofeedback plus capacitive-resistive radiofrequency) on chronic pelvic pain and dyspareunia: prospective study and literature review]. / Efectividad de la rehabilitación multimodal (biofeedback más radiofrecuencia capacitiva-resistiva) sobre el dolor pélvico crónico y la dispareunia: estudio prospectivo y revisión de la bibliografía.

OBJECTIVE: To determine whether a multimodal rehabilitation protocol (Biofeedback [BFB] plus capacitive-resistive [INDIBA®] radiofrequency [RF]) reduces pain and increases muscular strength in patients with chronic pelvic pain (CPP) and dyspareunia. MATERIAL AND METHODS: We performed a prospective, quasi-experimental, before-after study in 37 patients with CPP and/or dyspareunia referred to the Rehabilitation Department of Hospital Universitario Santa Cristina (January 2016 to December 2018). The protocol consisted of 8 sessions of pelvic floor exercises assisted by manometric BFB (15min of tonic/phasic exercises each) supervised by a physiotherapist, followed by suprapubic and perineovaginal bipolar RF [capacitive(5 min)/resistive(10 min)]. The variables evaluated were pain (VAS 0-10) and strength (mmHg) of the pelvic floor musculature and the start/end of the treatment. RESULTS: The mean age was 41.5±12.65 years. The prevalence was higher among women aged 21-40 years (n=20, 54%) and those aged 41-60 years (n=12; 32.4%). Dyspareunia was present in 34 patients (91.8%), and non-specific CPP in 3 (8.2%). The protocol improved pain (from 7.27±1.34 to 3.75±2.21 points), maximal muscular strength (from 25.56±15.9mmHg to 35.35±20.4mmHg) and mean muscular strength (from 4.86±3.53mmHg to 7.18±4.46mmHg) respectively (p<0.0001). CONCLUSION: CPP and dyspareunia are a diagnostic challenge that requires multidisciplinary management. Treatment should be started early and should consist of distinct therapeutic modalities. The protocol of multimodal rehabilitation including BFB and capacitive-resistive RF reduces pain and improves strength in patients with CPP and dyspareunia.

Interferential current: a new option for the treatment of sexual complaints in women with premature ovarian insufficiency using systemic hormone therapy: a randomized clinical trial.

OBJECTIVE: The aim of the study was to evaluate the efficacy of interferential current (IC) in the sexual function of women with premature ovarian insufficiency (POI) using systemic hormone therapy (HT), compared to topical estriol. METHODS: A randomized clinical trial with 40 women with POI using systemic HT, who were sexually active and referred for dyspareunia and reduction of lubrication. The women were divided into two treatment groups for 4 weeks: IC group (eight electrotherapy sessions twice a week); or E group (estriol vaginal cream, daily application, 0.5 mg/d). The Female Sexual Function Index was used to evaluate pre-/posttreatment sexual function. RESULTS: Mean age was 37.13 ±â€Š7.27 years and mean treatment time with HT was 8.20 ±â€Š8.73 years, similar data for both groups. There was an improvement in global sexual function, lubrication, and pain domains for both treatments. The differences between the pre-/posttreatment lubrication scores were respectively 0.75 ±â€Š3.31 (P = 0.014) for IC and 1.16 ±â€Š1.22 (P < 0.001) for estriol, whereas for dyspareunia the differences were 1.00 ±â€Š1.47 (P = 0.005) for IC, and 0.68 ±â€Š1.30 (P = 0.006) for estriol. There was no pre-/posttreatment difference for the desire and arousal domains. Only in the IC group did orgasm (difference 0.90 ±â€Š1.42, P = 0.010) and satisfaction improve (difference 0.70 ±â€Š1.28, P = 0.021). CONCLUSION: The use of perineal IC seems to be a new option for women with POI using systemic HT and presenting with sexual complaints, leading to an improvement in pain, lubrication, satisfaction, and orgasm.

What is the role of dehydroepiandrosterone in gynecologic practice?

In small clinical trials, dehydroepiandrosterone (DHEA) has been found to relieve symptoms associated with postmenopausal conditions and infertility in women. DHEA may provide a cost-effective alternative to typical hormone therapies. Because of a lack of long-term and large-scale studies, only intravaginal DHEA supplementation is approved and recommended for treatment. Further investigation of DHEA supplementation is needed and encouraged to determine its safety and effectiveness.

Pelvic floor rehabilitation in the treatment of women with dyspareunia: a randomized controlled clinical trial.

INTRODUCTION AND HYPOTHESIS: Dyspareunia, the symptom of painful sexual intercourse, is a common sexual dysfunction in reproductive-aged women. Because of its multifactorial etiology, a multidisciplinary approach may be required to treat it. Musculoskeletal factors play an important role; thus, rehabilitating the pelvic floor and modifying the tone of the pelvic floor muscles (PFMs) may be an effective way to treat this dysfunction. The aim of this randomized controlled clinical study was to evaluate the effects of pelvic floor rehabilitation techniques on dyspareunia. METHODS: Of 84 women, assessed for eligibility, 64 women with dyspareunia were randomized into two groups: the experimental group (n = 32) received electrotherapy, manual therapy, and PFM exercises and the control group (n = 32) had no treatment while on the waiting list. Evaluations of PFM strength and endurance, sexual function, and pain were made directly before and after 3 months of treatment and at the 3-month follow-up. RESULTS: Between-group changes showed significant improvement in the experimental group in comparison with control group. Mean difference in the PFM strength (according to the 0-5 Oxford scale) between groups was 2.01 and the mean difference of endurance was 6.26 s. Also, the mean difference in the Female Sexual Function Index score (the score ranges from 2 to 95) was 51.05, and the mean difference in the VAS score was 7.32. All of the changes were statistically significant (p < 0.05). CONCLUSIONS: According to the results, pelvic floor rehabilitation is an important part of a multidisciplinary treatment approach to dyspareunia.

Case Report: Treatment for Rectovaginal Fistula in Crohn's Disease Using Fractionate CO2 Vaginal Laser with Anti-TNF Therapy.

Background: Rectovaginal fistulas (RVFs) are defined as any connection between the anorectum and the vagina. They can have several causes, being Crohn's disease, the second leading cause of RVFs, responsible for ∼10% of the RVFs. Despite the advances in surgical and clinical treatment, there is no consensus regarding the best line of treatment. Objective: To report another therapeutic option, we describe the case of a patient with Crohn's disease and RVF refractory to anti-tumor necrosis factor (TNF) therapy, submitted to intravaginal CO2 fractional laser treatment. Materials and methods: Three laser sessions with monthly interval and analysis by clinical examination, sexual evaluation questionnaire, and magnetic resonance of the pelvis were performed. Results: We obtained an important improvement of the symptoms and of the dimension of the fistulous path. Conclusions: We believe this method to be a complementary, promising, and safe therapeutic alternative for the management of vaginal fistula. Future studies using this therapeutic strategy are needed to confirm the efficacy of this method in this clinical setting.