A Randomized Controlled Trial Comparing a New D-Mannose-based Dietary Supplement to Placebo for the Treatment of Uncomplicated Escherichia coli Urinary Tract Infections.

BACKGROUND: The rise in antimicrobial resistance means that alternative approaches for the treatment and prevention of urinary tract infection (UTIs) are required. OBJECTIVE: To evaluate the safety and efficacy of a D-mannose-based dietary supplement (D-mannose, citric acid, prebiotic fibers, Astragalus, and dandelion; DAPAD complex) for the treatment of uncomplicated acute E. coli UTIs. DESIGN, SETTING, AND PARTICIPANTS: This was a single-center, randomized, double-blind, placebo-controlled trial conducted from April 2021 to October 2021 in Rajalakshmi Hospital and Research Centre (Bangalore, India). The participants were nonmenopausal women with an acute uncomplicated E. coli UTI. UTI was diagnosed according to the presence of at least one urinary symptom and bacteriuria (>100 000 CFU/ml). INTERVENTION: The DAPAD complex was administered twice a day for 5 d, with phenazopyridine and alkalizing agents as the standard of care (SOC). The control group received placebo with SOC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Subjective (clinical resolution/response) and objective (midstream bacteriuria) outcomes were evaluated at the end of therapy (day 6) and at day 35 of follow-up. Adverse events were recorded. Categorical variables were analyzed using χ2 and Fisher's exact tests; a p value <0.05 was considered significant. RESULTS AND LIMITATIONS: Seventy women were enrolled and equally randomized to the two groups. Clinical resolution was higher in the DAPAD group at 6 d (34.3% vs 0%; p < 0.0001) and 35 d from baseline (88.6% vs 20%, p < 0.0001). At day 35, no patients in the DAPAD group had moderate or severe symptoms, whereas 25.7% (nine/35) and 11.4% (four/35) of patients in the placebo group had moderate and severe symptoms, respectively. Bacteriological resolution was also higher in the DAPAD group at day 6 (85.7% vs 14.3%; p < 0.0001) and day 35 (100% vs 40%; p < 0.0001). Three mild adverse events (4.26%) unrelated to the investigated product were recorded, all of which were medically treated. CONCLUSIONS: The DAPAD complex dietary supplement is effective and safe for treatment of acute uncomplicated E. coli UTIs. PATIENT SUMMARY: Our results show that for nonmenopausal women with an uncomplicated Escherichia coli urinary tract infection, those treated with a dietary supplement (containing D-mannose, citric acid, prebiotic fibers, Astragalus, and dandelion) had a higher rate of clinical resolution or response than women who received a placebo.

New Innovations for the Treatment of Vulvovaginal Atrophy: An Up-to-Date Review.

Vulvovaginal atrophy (VVA) is a chronic progressive disease involving the female genital apparatus and lower urinary tract. This condition is related to hypoestrogenism consequent to menopause onset but is also due to the hormonal decrease after adjuvant therapy for patients affected by breast cancer. Considering the high prevalence of VVA and the expected growth of this condition due to the increase in the average age of the female population, it is easy to understand its significant social impact. VVA causes uncomfortable disorders, such as vaginal dryness, itching, burning, and dyspareunia, and requires constant treatment, on cessation of which symptoms tend to reappear. The currently available therapies include vaginal lubricants and moisturizers, vaginal estrogens and dehydroepiandrosterone (DHEA), systemic hormone therapy, and Ospemifene. Considering, however, that such therapies have some problems that include contraindications, ineffectiveness, and low compliance, finding an innovative, effective, and safe treatment is crucial. The present data suggest great efficacy and safety of a vaginal laser in the treatment of genital symptoms and improvement in sexual function in patients affected by VVA. The beneficial effect tends to be sustained over the long-term, and no serious adverse events have been identified. The aim of this review is to report up-to-date efficacy and safety data of laser energy devices, in particular the microablative fractional carbon dioxide laser and the non-ablative photothermal Erbium-YAG laser.

Vaginal Laser Therapy for Female Stress Urinary Incontinence: New Solutions for a Well-Known Issue-A Concise Review.

Background and Objectives: Insufficient connective urethra and bladder support related to childbirth and menopausal estrogen decrease leads to stress urinary incontinence (SUI). The aim of this review is to narratively report the efficacy and safety of new mini-invasive solutions for SUI treatment as laser energy devices, in particular, the microablative fractional carbon dioxide laser and the non-ablative Erbium-YAG laser. Materials and Methods: For this narrative review, a search of literature from PubMed and EMBASE was performed to evaluate the relevant studies and was limited to English language articles, published from January 2015 to February 2022. Results: A significant subjective improvement, assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF) was reported at the 6-month follow up, with a cure rate ranged from 21% to 38%. A reduction of effect was evidenced between 6 and 24-36 months. Additionally, the 1-h pad weight test evidence a significant objective improvement at the 2-6-month follow up. Conclusions: SUI after vaginal laser therapy resulted statistically improved in almost all studies at short-term follow up, resulting a safe and feasible option in mild SUI. However, cure rates were low, longer-term data actually lacks and the high heterogeneity of methods limits the general recommendations. Larger RCTs evaluating long-term effects are required.

Mirabegron in female patients with overactive bladder syndrome: What's new? A systematic review and meta-analysis.

Reviews assessing mirabegron's safety and efficacy, synthesize data from both genders, without providing specific details for female patients with OAB. The aim of this study is to qualitatively and quantitatively synthesize data evaluating mirabegron's use on female patients with OAB. PubMed/Scopus/Cochrane library/Web of Knowledge were searched for full texted, published in English-language and in peer-reviewed journals, up to November 2019, using the keyword "mirabegron".Jadad score modified by adding allocation concealment, MINORS and RoB were used for the Methodological quality and risk of bias assessment. Twenty-one studies were included in this review;7 RCTs, 3 non-RCTs and 11 observational studies. Controlled trials were of unclear (75%), high (12.5%) or serious risk (12.5%) of bias. Twelve weeks of mirabegron use resulted in significant decrease of urgency, frequency, nocturia and UUI by 1.3-2.2,2.04-2.33,0.42-0.5 and 0.9-1.04 episodes/24 h, respectively. Quality of life and sexual health was improved significantly. Sexual dysfunction decreased from 98% (84/85) at baseline, to 60% (51/85) after 12-weeks of mirabegron (p-value < 0.001). Mirabegron had the same efficacy as anticholinergics in improving all OAB symptoms but with fewer adverse events. Hypertension and antimuscarinics' effects (i.e dry mouth, constipation) had an incidence of 2% (28/1221) and 1.9% (23/1221) when mirabegron was administered, respectively. Mirabegron is a safe and effective alternative therapy for females with OAB. However, there is a paucity of high-quality RCTs, with large sample sizes, long-term follow-up focusing on mirabegron's comparison to other therapies, quality of life and sexual health of female patients with OAB.

In response to the FDA warning about the use of photomedicine in gynecology.

To alert patients and health care providers about the use of energy-based devices to perform a vaginal "rejuvenation," cosmetic vaginal procedures, or nonsurgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function, the US Food and Drug Administration (FDA) has issued a warning about the effectiveness and safety of such devices. We agree with the FDA that certain devices (laser, radiofrequency, etc.) have been marketed inappropriately for uses that are outside of their cleared or approved intended uses. We want to position ourselves in the strict training of professionals so that the indications and techniques are used in the best possible way, knowing that, similar to any medical or surgical technique, the side effects can appear in the short and long term, and should be recognized and remedied.

Triptorelin for the treatment of endometriosis.

INTRODUCTION: Over the past 30 years, gonadotropin-releasing hormone agonists (GnRH-a) have been used to induce a hypoestrogenic status in women with endometriosis with the aim to cause an improvement in pain symptoms similar to that observed after menopause. Triptorelin is one of the most commonly used GnRH-a. AREAS COVERED: This review offers an explanation of the mechanism of action, of the pharmacokinetics and pharmacodynamics of triptorelin and gives the readers a complete overview of the studies on the clinical efficacy, tolerability and safety of this agent in patients with endometriosis. EXPERT OPINION: The studies reviewed in the current manuscript demonstrate the efficacy of triptorelin in improving pain symptoms caused by endometriosis. Further, this effect is confirmed by the reduction in the volume of the endometriotic nodules during treatment. Future research should evaluate whether the pre-operative administration of triptorelin prior to surgical excision of endometriomas may be useful in preserving the ovarian reserve.