Effective Treatment Option For Women Research Articles

A prospective multicenter European observational study of a single incision sling (Altis®): A safe and effective treatment option for women

Introduction:Single-incision slings were introduced for female stress urinary incontinence (SUI) treatment to decrease surgery time, postoperative pain, and the amount of mesh used. Objective:This multicenter study aims to examine Altis® usage in real-world clinical practice, its effectiveness in treating SUI, patient satisfaction, quality of life, sexual function, and complication rates. Methods:Between 2015 and 2022, a prospective single-arm observational cohort study was conducted across 33 European centers involving 564 patients, investigating the clinical effectiveness of the Altis® sling. Patients were monitored for 36 months. The primary endpoint (success) was a positive impression of improvement and absence of serious/severe/Clavien Dindo (CD) ≥ III-related adverse events at 12 months. Secondary endpoints included effectiveness at 36 months, impact on quality of life, and risk factors for failure. Results:An Altis® was implanted in 564 women. At 12-months, 86.6% of patients achieved success, 97.2% endorsed the surgery, and 90.4% were satisfied with the outcomes. At 36 months, 83.0% reported significant improvement, 94.5% endorsed the surgery, and 89.9% were satisfied. Altis® demonstrated decreased daily pad usage and improved quality of life. Dyspareunia and sexual function largely remained unchanged. However, 11.3% reported pain, and there were instances of serious adverse events. Conclusion:The Altis® implant demonstrated substantial improvements in symptoms and overall quality of life for a majority of women with SUI. Potential complications such as mesh exposure, reoperation, voiding dysfunction, and urinary retention emphasize the importance of preoperative counseling. The Altis® implant is a viable option within the available surgical treatments of SUI.

Long-term efficacy and safety of a bioresorbable polycaprolactone-based injectable in female stress incontinence

A fully bioresorbable polycaprolactone (PCL)-based bulking agent was evaluated for safety and efficacy in female patients with mild to moderate stress urinary incontinence (SUI) who attempted and failed prior pelvic floor muscle training. A total of 44 adult female subjects with mild or moderate SUI (median age 60 and 57, respectively) were treated by transurethral sub-mucosal injection. Safety was evaluated at 6-, 12-, and 24-month follow-up visits. Efficacy was assessed at the same intervals with the Stamey grading system (SGS). SGS improvement was shown in both the mild and moderate SUI groups. At 24 months, most participants were continent: 78.1% in the mild SUI group and 66.7% in the moderate SUI group. All participants in the moderate SUI group showed an improvement in the SGS grade, and most participants were continent. The study shows that the PCL-based bioresorbable bulking agent treatment seems to be a safe and effective treatment option for women with mild to moderate SUI who attempted and failed prior pelvic floor exercises.

Multicomponent Intervention for Overactive Bladder in Women

Although the cognitive components of behavioral therapy for overactive bladder (OAB) are widely recognized, there is a lack of studies evaluating the effectiveness of multicomponent interventions that include cognitive components as a treatment for OAB. To examine the efficacy of a multicomponent intervention in improving health-related quality of life (HRQOL) for women with moderate to severe OAB. This multicenter, open-label, randomized clinical trial was conducted in Japan among women aged 20 to 80 years who had moderate to severe OAB. Participants were recruited from 4 institutions between January 16, 2020, and December 31, 2022, through self-referral via advertisement or referral from the participating institutions. Participants were randomized 1:1 by minimization algorithm using an internet-based central cloud system to four 30-minute weekly sessions of a multicomponent intervention or waiting list. Both groups continued to receive baseline treatment throughout the study period. The primary outcome was the least-squares mean changes from baseline through week 13 in HRQOL total scores of the OAB questionnaire between 2 groups. Secondary outcomes included OAB symptom score and frequency volume chart. A total of 79 women were randomized to either the intervention group (39 participants; mean [SD] age, 63.5 [14.6] years) or the waiting list control group (40 participants; mean [SD] age, 63.5 [12.9] years). One participant from each group dropped out from the allocated intervention, while 5 participants in the intervention group and 2 in the control group dropped out from the primary outcome assessment at week 13. Thirty-six participants (92.3%) in the intervention group and 35 (87.5%) in the control group had moderate OAB. The change in HRQOL total score from baseline to week 13 was 23.9 points (95% CI, 18.4-29.5 points) in the intervention group and 11.3 points (95% CI, 6.2-16.4 points) in the waiting list group, a significant difference of 12.6 points (95% CI, 6.6-18.6 points; P < .001). Similar superiority of the intervention was confirmed for frequency of micturition and urgency but not for OAB symptom score. These findings demonstrate that a multicomponent intervention improves HRQOL for women with moderate to severe OAB and suggest that the cognitive component may be an effective treatment option for women with OAB. UMIN Clinical Trials Registry Identifier: UMIN000038513.

New Possibilities for Hormonal Vaginal Treatment in Menopausal Women.

Hormonal vaginal therapy is an effective treatment option for women who experience vaginal symptoms related to hormonal changes. Estrogen and prasterone are widely used as vaginal treatments, particularly for urogenital atrophy. These symptoms may include vaginal dryness, itching, burning, and pain during sexual intercourse, all of which can significantly affect a woman's quality of life. Previous studies have indicated that such treatment improves tissue elasticity, moisturizes the vagina, and can have a substantial impact on urine incontinence and vaginal microflora and decreases dyspareunia. Hormonal therapy is also useful and commonly used before vaginal surgical treatment. Prasterone is quite a new option for vaginal therapy in Poland and is mainly recommended for dyspareunia in menopausal women. The study related to prasterone therapy emphasizes its effectiveness and safety, making it advantageous to explore its beneficial impact. This paperwork aims to summarize the mechanism of action as well as the effects of both drugs and their beneficial action during vaginal treatment.

The influence of phytoestrogens on alleviating symptoms associated with menopause

Introduction and purpose. Menopause causes complaints such as hot flashes, night sweats, sleep problems and vaginal dryness. Hormone replacement therapy (HRT) is an effective treatment option for women with moderate to severe symptoms. In women who are unable to undergo HRT, plant-based preparations containing phytoestrogens can be used as an alternative. The purpose of this paper is to summarize the effectiveness of phytoestrogen supplementation.&#x0D; State of knowledge. Phytoestrogens are natural compounds structurally similar to estrogens, such as estradiol. They are divided into different classes, including isoflavones and lignans. Isoflavones, including genistein, found in soy products, cause a significant reduction in the severity of hot flashes, as well as improvements in vaginal dryness and sexual function. Lignans, found in flaxseed, sesame seeds and whole grains, have effects similar to endogenous estrogens, but studies to date have not shown significant efficacy of this group of substances in reducing menopausal symptoms. Resveratrol, a naturally occurring compound found in grapes and berries, has a weak estrogenic effect, whereby several clinical trials have demonstrated the effectiveness of resveratrol supplementation in alleviating menopausal symptoms.&#x0D; Conclusions. Phytoestrogens have been shown to alleviate some symptoms of menopause, such as hot flashes and night sweats, and may also have positive effects on bone density and cognitive abilities. Effects may vary depending on the source, dose and duration of treatment. There are also potential risks associated with their use, for which reason more research is needed to fully understand their effectiveness and safety.

Effect of flibanserin on libido in women with breast cancer on adjuvant endocrine therapy.

12015 Background: Breast cancer and its treatment can cause decreased libido. This study evaluates the use of Flibanserin in women with breast cancer on endocrine therapy who are experiencing decreased libido. It is the first study evaluating Flibanserin for medically induced decreased libido. Methods: 37 women (mean age of 49) with stage 0-III ER+ breast cancer on endocrine therapy for at least three months were enrolled on a longitudinal IRB-approved trial from both an academic center and an alliance community site. All patients met criteria for the diagnosis of HSDD as defined by the DSM-IV and ISSWSH consensus paper. Patients took Flibanserin 100mg at bedtime for 24 weeks and were followed for 52 weeks. Patients were monitored closely with medical exams and questionnaires at baseline, weeks 4, 8, 16, 24 and 52. Feasibility and efficacy of Flibanserin was measured by patient reported validated instruments such as Female Sexual Function Index (FSFI), Pittsburg Sleep Quality Index (PSQI), PROMIS, and EQ5D. Results: A statistically significant improvement in the sexual domains of desire, arousal, lubrication, orgasm, satisfaction, and pain were seen as measured by the FSFI while on Flibanserin, which declined after discontinuing the medication. At baseline, patients had an average libido of 1.7, which increased to 2.8 at 24 weeks and declined to 2.5 after discontinuing treatment. Sexual confidence and satisfaction at baseline were an average of 1.2 and 1.6 respectively and increased to an average of 2.5 and 2.6 after treatment. Ability to become lubricated was 1.3 at baseline and increased to 4.4 at 24 weeks. Ability to maintain lubrication and ease of lubrication both averaged 1.6 at baseline and increased to 3.4 at week 24. Ease and frequency of climax scored an average 1.4 at baseline, then increased to 2.6 and 2.9 respectively at week 24. Patients reported less pain and distress with sexual intercourse throughout the study and an increased number of sexually satisfying events. At baseline, the average score for overall state of health was 78/100. At 24 weeks, the average score increased to 93 and declined to 82 at week 52 (after medication was discontinued). Patients slept an average of 6.7 hours per night at baseline, which increased to 7.7 hours on Flibanserin and decreased to 5.5 hours after discontinuing the medication. Conclusions: Our study found statistically significant improvement in the sexual domains of desire, arousal, lubrication, orgasm, satisfaction, and pain as measured by the FSFI from baseline to week 24 while on Flibanserin. It also showed improved overall health-related quality of life and sleep. Flibanserin is an effective treatment option for women with breast cancer. A larger randomized placebo-controlled study is still needed to further evaluate Flibanserin in women with breast cancer and medically induced decreased libido. Clinical trial information: NCT03707340 .

Safety and tolerability of progesterone treatment for women with cocaine use disorder: a pilot treatment trial

ABSTRACT Background: Problematic cocaine use remains a significant public health issue, particularly among women. However, no concerted efforts have been made to target a pharmacological treatment option for women with cocaine use disorder (CUD) despite preclinical, human laboratory, and a limited number of clinical studies demonstrating that progesterone can attenuate the effects of cocaine to a greater extent in women than men. Objectives: To evaluate the safety, tolerability, and preliminary efficacy of progesterone for treating women with CUD. Methods: A 10-week double-blind randomized treatment trial was conducted. Prior to randomization, participants were required to achieve cocaine abstinence (1 week) before assignment to progesterone (up to 400 mg/day) or placebo. The primary efficacy outcomes were days to relapse and cocaine abstinence during the last 3 weeks of the trial. The frequency of side effects was also assessed. Results: 227 women were assessed for eligibility. Twenty-five women entered treatment and 21 were randomized to progesterone (n = 11) or placebo (n = 10). The majority of women relapsed in less than 4 days with no differences between the two groups. Further, there were no significant differences between the progesterone and placebo groups in terms of cocaine abstinence during the last 3 weeks of the trial (27% and 10% respectively). The most commonly reported side effects were headache and fatigue, but no group differences were noted. Conclusions: Progesterone was well tolerated and safe and supports further study is in a larger sample to determine if exogenous progesterone is an effective treatment option for women with CUD. (ClinicalTrials.gov Identifier: NCT00632099)

Life underneath the VCA umbrella: Perspectives from the US Uterus Transplant Consortium.

The parallel emergence of uterus transplantation (UTx) and other transplantation innovations including face and hand transplantation led to the categorization of the uterus as a vascular composite allograft (VCA). With >60 transplants and >20 births worldwide, UTx is transitioning rapidly from a research endeavor to an effective treatment option for women with uterine factor infertility. While it originally made sense to group the innovations under one umbrella, it is time to revisit the designation of UTx as a VCA. We describe how UTx needs unique policy, procedural codes, insurance contracts, and educational initiatives. We contend that separating UTx from VCAs may become necessary in the future to avoid hindering the growth and regulation of this field.

Evidence-Based Women’s Health Physical Therapy Across the Lifespan

The aim of this paper is to review the current evidence for physical therapy (PT) in the treatment of pelvic floor disorders (PFDs) in women throughout the female lifespan. Although trials are small and heterogeneous, there is an increase in evidence to support PT as a safe, effective treatment option for women with PFDs at various life stages. Evidence to support PT interventions for pelvic floor conditions including dysmenorrhea, chronic pelvic pain, dyspareunia, urinary incontinence, pelvic organ prolapse, and genitourinary syndrome of menopause are discussed. Clinicians are recommended to consider prevention and wellness strategies to promote pelvic health for women and screen for PFDs for early intervention. At various stages along the lifespan, a woman may be at risk for PFDs, impacting function, and quality of life. Knowledge of the potential risk factors based on a women’s history and life stage to appropriately screen for PFDs may facilitate early intervention. Pelvic health PT is considered to be a low risk, effective treatment option for women with PFDs. Future research is needed to determine longer term outcomes and potential prevention strategies for women on a larger scale.

Vaginal laser for overactive bladder syndrome

Overactive bladder syndrome (OAB) is defined as urinary urgency, usually with urinary frequency and nocturia, with or without urge urinary incontinence. The prevalence of OAB in adult women ranges between 11% and 42%, is particularly common in elderly people, and can overlap with the genitourinary syndrome of menopause (GSM). There is a wide approach to the treatment of symptoms, often in a stepwise fashion, including lifestyle changes, bladder retraining and pelvic floor muscle rehabilitation, drug therapy, intra-vesical botulinum toxin injections or neuromodulation. Recently, vaginal laser therapy has been proposed as an emerging minimal invasive effective treatment option for women with OAB. We explore this further.

Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies.

Background: Radiofrequency ablation (RFA) has emerged as a safe and effective treatment option for women with symptomatic uterine fibroids and can be delivered by laparoscopic, transvaginal, or transcervical approaches. The evidence regarding typical patient outcomes with RFA has not previously been examined in a comprehensive fashion.Materials and Methods: We performed a systematic review of prospective studies for treatment of uterine fibroids with RFA. Main outcomes were procedure time, patient recovery metrics, change in fibroid volume, symptom severity score (SSS), health-related quality of life (HRQL), and reinterventions. Data were analyzed with random effects meta-analysis and metaregression.Results: We identified 32 articles of 1283 unique patients (median age: 42 years) treated with laparoscopic RFA (19 articles), transvaginal RFA (8 articles), or transcervical fibroid ablation (5 articles). Mean procedure time was 49 minutes, time to discharge was 8.2 hours, time to normal activities was 5.2 days, and time to return to work was 5.1 days. At 12 months follow-up, fibroid volume decreased by 66%, HRQL increased by 39 points, and SSS decreased by 42 points (all P < .001 versus baseline). The annual cumulative rate of reinterventions due to fibroid-related symptoms was 4.2%, 8.2%, and 11.5% through 3 years.Conclusions: RFA of uterine fibroids significantly reduces fibroid volume, provides significant durable improvements in fibroid-related quality of life, and is associated with favorable reintervention rates.

Efficacy of transcranial direct-current stimulation (tDCS) in women with provoked vestibulodynia: study protocol for a randomized controlled trial.

BackgroundProvoked vestibulodynia is the most common form of vulvodynia. Despite its high prevalence and deleterious sexual, conjugal, and psychological repercussions, effective evidence-based interventions for provoked vestibulodynia remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Growing evidence suggests that the central nervous system (CNS) could play a key role in provoked vestibulodynia; thus, treatment targeting the CNS, rather than localized dysfunctions, may be beneficial for women suffering from provoked vestibulodynia. In this study, we aim to build on the promising results of a previous case report and evaluate whether transcranial direct-current stimulation, a non-invasive brain stimulation technique targeting the CNS, could be an effective treatment option for women with provoked vestibulodynia.Methods/designThis single-center, triple-blind, parallel group, randomized, controlled trial aims to compare the efficacy of transcranial direct-current stimulation with sham transcranial direct-current stimulation in women with provoked vestibulodynia. Forty women diagnosed with provoked vestibulodynia by a gynecologist, following a standardized treatment protocol, are randomized to either active transcranial direct-current stimulation treatment for ten sessions of 20 minutes at an intensity of 2 mA or sham transcranial direct-current stimulation over a 2-week period. Outcome measures are collected at baseline, 2 weeks after treatment and at 3-month follow-up. The primary outcome is pain during intercourse, assessed with a numerical rating scale. Secondary measurements focus on the sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction, and the patient’s global impression of change.DiscussionTo our knowledge, this study is the first randomized controlled trial to examine the efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia. Findings from this trial are expected to provide significant information about a promising intervention targeting the centralization of pain in women with provoked vestibulodynia.Trial registrationClinicaltrials.gov, NCT02543593. Registered on September 4, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1366-5) contains supplementary material, which is available to authorized users.

Internet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster.

BackgroundThere are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed.ObjectiveIn a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching.MethodsThis was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women’s diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9).ResultsAt the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average.ConclusionsOur results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT.Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf).

Methotrexate does not affect ovarian reserve or subsequent assisted reproductive technology outcomes.

The purpose of this research was to study whether methotrexate (MTX) as treatment for ectopic pregnancy (EP) impacts the future fertility of women undergoing assisted reproductive technology (ART) METHODS: In a systematic review and multi-center retrospective cohort from four academic and private fertility centers, 214 women underwent an ART cycle before and after receiving MTX as treatment for an EP. Measures of ovarian reserve and responsiveness and rates of clinical pregnancy (CP) and live birth (LB) were compared in the ART cycles prior and subsequent to MTX. Seven studies were identified in the systematic review, and primary data from four institutions was included in the final analysis. Women were significantly older in post-MTX cycles (35.3 vs 34.7years). There were no differences in follicle stimulating hormone, antral follicle count, duration of stimulation, oocytes retrieved, or fertilization rate between pre- and post-MTX cycles. However, post-MTX cycles received a significantly higher total dose of gonadotropins (4206 vs 3961IU). Overall, 42% of women achieved a CP and 35% achieved a LB in the post-MTX ART cycle, which is similar to national statistics. Although no factors were identified that were predictive of LB in young women, the number of oocytes retrieved in the previous ART cycle and current AFC were predictive of LB (AUC 0.76, 0.75) for the older women. MTX does not influence ovarian reserve, response to gonadotropin stimulation, and CP or LB rate after ART. MTX remains a safe and effective treatment option for women with asymptomatic EPs.

Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer

Lapatinib plus capecitabine (lap+cap) is approved as treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC), who have progressed on prior trastuzumab in the metastatic setting.We previously reported progression-free survival (PFS), overall survival (OS) and safety results from this open-label, multicentre, phase II study (VITAL; NCT01013740) conducted in women with HER2 positive MBC, to evaluate the efficacy and safety of lap plus vinorelbine (lap+vin), an important chemotherapy option for MBC, compared with lap+cap. In total, 112 patients were randomised 2:1 to treatment with lap+vin (N = 75) or lap+cap (N = 37). Results showed that the median PFS (primary endpoint) and OS (secondary endpoint) post-randomisation were comparable between treatment arms, with no new safety signals detected.Here, we assessed the final OS in this study at 40 months post-randomisation. At the time of final analyses, 24 (32%) patients were ongoing in the lap+vin arm, compared with 14 (38%) patients in the lap+cap arm (92% in both arms had discontinued treatment). Median OS in the lap+vin arm was 23.3 months (95% confidence intervals [CI]: 18.5, 31.1), compared with 20.3 months (95% CI: 16.4, 31.8) in the lap+cap arm. The median follow-up in the lap+vin arm was 18.86 months (95% CI: 10.68, 26.02), compared with 19.38 (95% CI: 25.56) months in the lap+cap arm. Similar rates of death (56–57%) were observed in both arms.The final OS was consistent with the previously reported data and suggest that lap+vin offers an effective treatment option for women with HER2-positive MBC.

Normalized Relative Contrast Improves the Power of Pre-Therapy Contrast-Enhanced MRI to Predict the Prognosis of Uterine Leiomyoma Treated With Uterine Artery Embolization

Background: Uterine artery embolization (UAE) has emerged as an effective treatment option for women with symptomatic uterine leiomyomas, the most common benign tumor of the female reproductive system. Assessing factors that aid in predicting treatment outcomes is critical for patient selection, procedure planning and post-procedural follow-up. Previous studies have demonstrated variable correlations between MRI predictors and response to UAE. In this study, we investigated if the relative tumor to intratumor myometrium contrast may improve the predictive power of pre-therapy contrast-enhanced MRI. Methods: A retrospective study of a total of 42 uterine leiomyomas treated with UAE was performed. Treated tumors were categorized as either fully or not fully responsive based on if they became completely necrotic 3 - 6 months post-UAE. Results: There was no significant difference (P = 0.34) in the pre-UAE contrast to noise ratio (CNR) between fully responsive (64.6 ± 38.6) and not fully responsive (74.2 ± 24.8) tumors. On the other hand, the pre-UAE relative contrast of not fully responsive tumors was significantly higher than the fully responsive tumors (1.6 ± 0.4 vs. 1.0 ± 0.4, P < 0.05). Pre-UAE tumor relative contrast was found to correctly predict 7/9 not fully responsive and 30/33 fully responsive tumors at a threshold of 1.3. Larger area under the receiver operating characteristic (ROC) curve based on relative contrast than that based on CNR also indicated that relative contrast improved the predictive power of pre-therapy contrast-enhanced MRI. Conclusion: Upon further validation with large studies, pre-UAE relative contrast may prove to be a useful tool to predict UAE treatment outcome of leiomyomas and improve the clinical management of uterine leiomyoma. J Clin Gynecol Obstet. 2015;4(1):164-169 doi: http://dx.doi.org/10.14740/jcgo279w

Transobturator tension-free vaginal tape is the most common procedure in women with stress urinary incontinence: our experience

Transobturator tension-free vaginal tape (TVT-O) surgery is currently one of the most effective procedures used to treat women with stress urinary incontinence (SUI), however, long-term follow-up data in medical literature is scarce. For this study, we enrolled women with SUI assessed by an urodynamic examination and a translabial ultrasound with a pelvic organ prolapse no greater than grade 2. All of the women were also given a pre- and postoperative test to assess their quality of life. They were given a thorough physical examination, asked to keep a voiding diary, and underwent an urodynamic examination and a translabial ultrasound. Additionally, we also further evaluated intraoperative and postoperative complications and the onset of &lt;em&gt;de novo&lt;/em&gt; detrusor overactivity after the procedure. We also assessed the long-term efficacy of the TVT-O in those women with SUI caused by sphincter hypotonia. All of the women underwent TVT-O surgery without any associated procedure. Our findings indicate that TVT-O surgery is an effective treatment option for women with SUI, showing a very high cure rate and a low incidence of complications, with sustained outcomes even in the long-term. However, in women with SUI caused by sphincter hypotonia, the excellent outcomes in early stages tend to dwindle over time

Carbamazepine clearance and seizure stability during pregnancy

The aims of this study were to characterize the alterations in total and free carbamazepine (CBZ) and in total and free carbamazepine-epoxide (CBZ-EPO) clearances during pregnancy, to calculate the change in free fractions of CBZ and CBZ-EPO during pregnancy, and to determine whether seizure worsening is associated with a low ratio to nonpregnant baseline concentration of total or free CBZ or CBZ-EPO. Women on CBZ were enrolled before conception or during pregnancy in this prospective, observational study. Concomitant medications and seizure frequency were recorded. Serum total and free CBZ and CBZ-EPO were collected at each visit. Changes in the clearance of all four compounds and free fractions of CBZ and CBZ-EPO were compared with nonpregnant baseline. During pregnancy, the ratios to baseline concentrations of total and free CBZ and CBZ-EPO were compared for months with and without increased seizure frequency. Total and free CBZ and CBZ-EPO clearances were calculated in 15 pregnancies in 12 women. Clearances did not change for any of these compounds during pregnancy. The free fraction of CBZ increased from 0.23 at baseline to a maximum of 0.32 in the third trimester (p=0.008). In the six women on CBZ monotherapy with adequate seizure diaries and blood sampling, seizure worsening did not correspond to a ratio to baseline concentration of less than 0.65 for total or free CBZ or CBZ-EPO. In conclusion, total and free CBZ and CBZ-EPO clearances did not change substantially during pregnancy, and seizure frequency worsening was not associated with decreased concentrations of total or free CBZ; therefore, therapeutic drug monitoring may not be necessary for all women on CBZ during pregnancy. Further studies with larger sample sizes are needed before definitive recommendations can be made. Carbamazepine monotherapy may be a relatively safe and cost effective treatment option for women with focal epilepsy syndromes during pregnancy.

Vaginal mifepristone for the treatment of symptomatic uterine leiomyomata: an open-label study

To evaluate the efficacy and safety of 3 months of vaginal mifepristone treatment on leiomyoma volume and related symptoms. Prospective, open-label, two tertiary centers, phase II clinical trial. Two tertiary medical centers in Israel. Thirty-three enrolled women, ages 30-53 years, diagnosed with symptomatic uterine fibroids. Patients received 10 mg mifepristone vaginally daily for 3 months. Reduction in uterine leiomyoma volume. Improvement in symptoms related to uterine fibroids was assessed with the use of the "Uterine Fibroid Symptoms Quality of Life Questionnaire" (UFS-QoL). The number of bleeding days, safety, and tolerability were secondary measures. Mifepristone treatment significantly reduced leiomyoma volume from 135.3 ± 22.9 cc at enrollment to 101.2 ± 22.4 cc after 3 months of treatment. The UFS-QoL Score significantly decreased from 20.7 ± 0.7 at enrollment to 14.0 ± 0.8 after 3 months of treatment. The number of bleeding days significantly decreased by 3.5 days. Endometrial biopsies showed no evidence of endometrial hyperplasia or cellular atypia. There were no major side effects during the course of the study, and treatment was well tolerated. Vaginal mifepristone may offer an effective treatment option for women with symptomatic uterine leiomyoma and can improve the patients' quality of life. NCT00881140.

Effectiveness of group and self-help cognitive behavior therapy in reducing problematic menopausal hot flushes and night sweats (MENOS 2)

The aim of this study was to examine the effectiveness of group cognitive behavioral therapy (CBT) and guided self-help CBT in reducing hot flush and night sweat (HF/NS) problem rating at 6 and 26 weeks after randomization. This was a randomized control trial of 140 women having 10 or more problematic HF/NS a week for at least a month. The primary outcome was HF/NS problem rating (1-10) at 6 weeks after randomization. Secondary outcomes were physiologically measured HF/NS at 6 weeks; HF/NS problem rating at 6 weeks; and frequency, mood (Women's Health Questionnaire), and health-related quality of life (General Health Survey Short Form-36) at 6 and 26 weeks. Intention-to-treat analysis was used, and between-group differences were estimated using linear mixed models. Baseline mean (SD) HF/NS weekly frequency was 63.15 (49.24), and problem rating was 5.87 (2.28). Group and self-help CBT both significantly reduced HF/NS problem rating at 6 weeks-group CBT versus no treatment control (NTC; adjusted mean difference, 2.12; 95% CI, 1.36-2.88; P < 0.001) and self-help CBT versus NTC (adjusted mean difference, 2.08; 95% CI, 1.29-2.86; P < 0.001)-and at 26 weeks-group CBT versus NTC (adjusted mean difference, 1.33; 95% CI, 0.54-2.13; P = 0.001) and self-help CBT versus NTC (adjusted mean difference, 1.19; 95% CI, 0.36-2.02; P = 0.005). Group and self-help CBT significantly reduced night sweat frequency at 6 and 26 weeks. There were improvements in mood and quality of life at 6 weeks and improved emotional and physical functioning for group CBT at 26 weeks. These results suggest that CBT delivered in group or self-help format is an effective treatment option for women during the menopause transition and postmenopause with problematic HF/NS.