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Genitourinary Syndrome of Menopause (GSM) defines a set of symptoms associated with an estrogen deficit involving alterations in organs genitourinary and that results in several urinary, genital, and sexual alterations. Brazilian women live about a third of their life after menopause, where hormonal changes occur along with clinical manifestations, characterized by vaginal and vulvar dryness, burning sensation, discomfort, vulvovaginal irritation, lack of lubrication, dyspareunia and urinary incontinence. Fractionated photothermolysis and radiofrequency systems, alone or in combination were tested to improve GSM. The goal of this study is to elaborate a protocol to evaluate the clinical response of patients with symptoms of GSM after the application of photobiomodulation in the vulvar region. In this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of GSM will be randomly divided into two groups. The treatment group (n = 30) will receive four consecutive applications, weekly, using DMC laser diode (λ = 808 nm), 4J per point, 100mW of power, 1,016W/cm2, 8 sites in the vulvar region, The Placebo Group (n = 30) will be handled as treated, but with the laser turned off. The quality of life will be assessed using female sexual functioning index (FSFI-6), urinary incontinence questionnaire (ICIQ-SF), Quality of life will be analyzed using the female sexual functioning index (FSFI-6). The intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI). Also, the vaginal temperature will be measured using a thermal camera, the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. With this procedure, we intend to obtain an overall better life quality and diminished symptoms in women with GSM. All assessments will be performed prior to the first irradiation and after the last one. This protocol is registered at ClinicalTrials.gov under the number NCT05557799.

Purpose Although vaginal dilator use after combined pelvic radiation therapy and brachytherapy (RT/BT) is recommended to prevent vaginal shortening and stenosis, women fail to use them and experience sexual problems. A nurse-led sexual rehabilitation intervention targeting sexual recovery and vaginal dilatation was developed. Its feasibility was investigated during a prospective, longitudinal, observational pilot study. Methods Four oncology nurses were specifically trained to conduct the intervention. Gynecologic cancer patients treated with RT/BT were assessed using (i) questionnaires on frequency of dilator use (monthly), sexual functioning, and sexual distress (at baseline and 1, 6, and 12 months) and psychological and relational distress (at 1, 6, and 12 months); (ii) semi-structured interviews (between 6 and 12 months); and (iii) consultation recordings (a random selection of 21 % of all consults). Results Twenty participants were 26–71 years old (mean = 40). Eight participants discontinued participation after 3 to 9 months. At 6 months after RT, 14 out of 16 (88 %), and at 12 months 9 out of 12 (75 %), participants dilated regularly, either by having sexual intercourse or by using dilators. Sexual functioning improved between 1 and 6 months after RT, with further improvement at 12 months. Most participants reported that the intervention was helpful and the nurses reported having sufficient expertise and counseling skills. Conclusions According to the pilot results, the intervention was feasible and promising for sexual rehabilitation and regular dilator use after RT. Its (cost-)effectiveness will be investigated in a randomized controlled trial.

Vaginal laxity is an underreported condition that negatively affects women's sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity. This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp-REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention). The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity. Registry: RBR-2zdvfp-Registro Brasileiro de Ensaios Clínicos-REBEC (19/02/2020).

Antenatal vaginal progesterone (VP) reduces the risk of preterm birth (PTB) in women with shortened cervical length, and we hypothesize that it may also prevent PTB in women with HIV as their primary risk factor. We conducted a pilot feasibility study in Lusaka, Zambia to investigate uptake, adherence, and retention in preparation for a future efficacy trial. This was a double-masked, placebo-controlled, randomized trial of 200mg daily self-administered VP suppository or placebo. Pregnant women with HIV who were initiating or continuing antiretroviral therapy were eligible for participation. Potential participants underwent ultrasound to assess eligibility; we excluded those ≥24 gestational weeks, with non-viable, multiple gestation, or extrauterine pregnancies, with short cervix (<2.0cm), or with prior spontaneous PTB. Participants initiated study product between 20-24 weeks of gestation and continued to 37 weeks (or delivery, if sooner). The primary outcome was adherence (proportion achieving ≥80% study product use), assessed by dye stain assay of returned single-use vaginal applicators. Secondary outcomes with pre-defined feasibility targets were: uptake (≥50% eligible participants enrolled) and retention (≥90% ascertainment of delivery outcomes). We also evaluated preliminary efficacy by comparing the risk of spontaneous PTB <37 weeks between groups. From July 2017 to June 2018, 208 HIV-infected pregnant women were eligible for screening and 140 (uptake = 67%) were randomly allocated to VP (n = 70) or placebo (n = 70). Mean adherence was 94% (SD±9.4); 91% (n = 125/137) achieved overall adherence ≥80%. Delivery outcomes were ascertained from 134 (96%) participants. Spontaneous PTB occurred in 10 participants (15%) receiving placebo and 8 (12%) receiving progesterone (RR 0.82; 95%CI:0.34-1.97). Spontaneous PTB < 34 weeks occurred in 6 (9%) receiving placebo and 4 (6%) receiving progesterone (RR 0.67; 95%CI:0.20-2.67). In contrast to findings from vaginal microbicide studies in HIV-uninfected, non-pregnant women, our trial participants were highly adherent to daily self-administered vaginal progesterone. The study's a priori criteria for uptake, adherence, and retention were met, indicating that a phase III efficacy trial would be feasible.

Contraceptive vaginal rings could play a role in expanding the contraceptive method mix and in preparing communities for the introduction of HIV prevention and multipurpose rings. We conducted an open label single-centre randomised clinical trial of intermittent versus continuous use of NuvaRing® in Kigali, Rwanda, in 2013-2014. We randomised 120 HIV-negative women 1:1 to intermittent use (three rings with a ring-free week in between rings) or continuous use (four rings without ring-free weeks). Women underwent an interview, counselling, and a speculum examination, and were tested for pregnancy, bacterial vaginosis (BV) by Nugent scoring, yeasts and trichomonads on wet mount, and sexually transmitted infections. Only one woman withdrew early. Deliberate ring removals were rare, but spontaneous ring expulsions occurred during 14% of ring use periods. There were no incident pregnancies, serious adverse events, serious social harms, or early discontinuations for safety reasons. Systemic side effects were uncommon, and local side effects were not significantly differently distributed between groups except for lower abdominal pain (P = 0.013). The incidence of vaginal yeasts during ring use was high: 22% of intermittent users and 27% of continuous users had incident vaginal yeasts at one or multiple ring removal visits (P = 0.666), and symptomatic vaginal yeast cases were more common in the continuous than intermittent users (P = 0.031). In contrast, mean Nugent scores improved over time in both groups. Intermittent and continuous NuvaRing® use were safe in Rwandan women and improved Nugent scores over time. However, attention should be paid to ring expulsions and to a potential increased risk of vaginal candidiasis.

Introduction. Urinary incontinence (UI) is a health problem affecting the quality of women’s lives (QOL) at various life stages. Stress urinary incontinence (SUI) can be caused by previous vaginal deliveries and is especially likely to occur in the perimenopausal period. The most commonly recommended first-choice treatment methods involve exercises for the pelvic floor muscles (PFM). The aim of this study was to assess the impact of isolated PFM exercises and combined training of the PFM and the m.transversus abdominis (TrA) muscle on the QoL of patients with SUI with regard to the number of vaginal deliveries. Material and Methods. 137 women with SUI were qualified for analysis (mean age 53,1 ± 5,5). To assess the effectiveness of PFM training QOL questionnaire was used (ICIQ-LUTS qol). PFM training for groups A (PFM+TrA) and B (PFM) was intended for 12 weeks. Statistica v. 12.0 PL, StatSoft, USA, was used for statistical calculations. Results. The analysis demonstrated that conservative treatment based on the A training program (PFM + TrA) yielded statistically significantly better results than the B program (PFM), with the improvement observed in such QoL domains as the performance of household duties, physical activity and travelling, social limitations, emotions, sleep problems and fatigue, the frequency of changing panty liners, fluid intake control, and embarrassment. Conclusion. Both the combined training of the PFM and the synergistic (TrA) muscle and the isolated PFM exercises improve the QoL of women with SUI. Nonetheless, the combined PFM and TrA muscle physiotherapy is more effective. The exercises for the PFM and the synergistic muscle give better results in women who have given birth fewer than three times than isolated PFM exercises.

PurposeTo assess the effects of the combination of pelvic floor rehabilitation and intravaginal estriol administration on stress urinary incontinence (SUI), urogenital atrophy and recurrent urinary tract infections in postmenopausal women.MethodsTwo-hundred-six postmenopausal women with urogenital aging symptoms were enrolled in this prospective randomized controlled study. Patients were randomly divided into two groups and each group consisted of 103 women. Subjects in the treatment group received intravaginal estriol ovules, such as 1 ovule (1 mg) once daily for 2 weeks and then 2 ovules once weekly for a total of 6 months as maintenance therapy plus pelvic floor rehabilitation. Subjects in the control group received only intravaginal estriol in a similar regimen. We evaluated urogenital symptomatology, urine cultures, colposcopic findings, urethral cytologic findings, urethral pressure profiles and urethrocystometry before, as well as after 6 months of treatment.ResultsAfter therapy, the symptoms and signs of urogenital atrophy significantly improved in both groups. 61/83 (73.49%) of the treated patients, and only 10/103 (9.71%) of the control patients referred a subjective improvement of their incontinence. In the patients treated by combination therapy with estriol plus pelvic floor rehabilitation, we observed significant improvements of colposcopic findings, and there were statistically significant increases in mean maximum urethral pressure (MUP), in mean urethral closure pressure (MUCP), as well as in the abdominal pressure transmission ratio to the proximal urethra (PTR).ConclusionsOur results showed that combination therapy with estriol plus pelvic floor rehabilitation was effective and should be considered as a first-line treatment for symptoms of urogenital aging in postmenopausal women.

Background. A Nugent score > 7 has been defined as the gold standard for the diagnosis for bacterial vaginosis (BV), though it is resource intensive and impractical as point of care testing. We sought to determine if colorimetric assessment of vaginal pH can accurately predict the occurrence of BV. Methods. We performed a planned subanalysis of 1,216 pregnant women between 13 0/7 and 19 6/7 weeks who underwent vaginal examination as part of a randomized controlled trial. Using a standardized technique, specimens were obtained for colorimetric assessment and two separate slides for Gram staining. These slides were subsequently evaluated by two independent blinded microbiologists for Nugent scoring. Results. Interrater reliability of the interpretation of the Nugent score was excellent (intraclass correlation-individual 0.93 (95 CI 0.92 to 0.94) and average 0.96 (95% CI 0.95 to 0.97)). The sensitivity of an elevated pH > 5 for a Nugent score > 7 was 21.9% while the specificity was 84.5%. The positive predictive value in our population was 33.7% with a negative predictive value of 75.0%. Conclusion. Though the Nugent score is internally accurate, the prediction of BV using vaginal pH alone has poor sensitivity and specificity.

We examined potential differences in women’s likelihood of sexual risk taking in a laboratory setting based on alcohol intoxication and sexual abuse history. Participants ( n  = 64) were classified as non-sexually abused (NSA) or as having experienced sexual abuse in childhood only (CSA) or adulthood only (ASA) and randomly assigned to consume alcoholic (.06, .08, or .10% target blood alcohol content) or non-alcoholic drinks, after which participants read and responded to a risky sex vignette. Dependent measures included vaginal pulse amplitude, self-reported sexual arousal, likelihood of engaging in condom use and risky sexual behaviors described in the vignette, and mood. NSA and ASA women did not differ significantly on any dependent measures. CSA women reported significantly lower likelihood of condom use and unprotected intercourse relative to NSA and ASA women. Intoxicated women reported significantly greater sexual arousal, positive mood, and likelihood of risky sex relative to sober women. Intoxicated CSA women reported significantly more likelihood of unprotected oral sex and less likelihood of condom use relative to intoxicated NSA and ASA and sober CSA women. CSA women’s increased risk of sexually transmitted infections (STIs) may be driven by non-condom use and behavioral changes while intoxicated. These findings provide preliminary insight into situational influences affecting CSA women’s increased STI risk.

The aim of the study was to measure pelvic floor muscle function in continent and incontinent nulliparous pregnant women. The study group consisted of 103 nulliparous pregnant women at 20 weeks of pregnancy. Women reporting urinary incontinence once per week or more during the previous month were classified as incontinent. Function was measured by vaginal squeeze pressure (muscle strength) and increment in thickness of the superficial pelvic floor muscles (urogenital diaphragm) assessed by perineal ultrasound. Seventy-one women were classified as continent and 32 women as incontinent. Continent women had statistically significantly higher maximal vaginal squeeze pressure and increment in muscle thickness when compared with incontinent women. There was a strong correlation between measurements of vaginal squeeze pressure and perineal ultrasound measurements of increment in muscle thickness. This study demonstrates statistically significant differences in pelvic floor muscle function measured by strength and thickness in continent compared with incontinent nulliparous pregnant women.[PUBLICATION ABSTRACT]