Prospective randomized study to evaluate and compare the post-procedural sexual function in patients undergoing semi-rigid ureterorenoscopy for distal ureteric stones in three different operating room settings.

Objective: To evaluate and compare the effect of semi-rigid ureterorenoscopy on post-procedural sexual function with three different operating room settings. Methods: In this prospective randomized study, consecutive sexually active patients with normal pre-operative sexual function undergoing uncomplicated semi-rigid ureterorenoscopy for distal ureteric stones were randomized into three groups, with three different operating room settings. Procedure-related anxiety and sexual function were assessed pre-operatively using Amsterdam Preoperative Anxiety and Information Scale and Brief Sexual Function Inventory (in males) and Female Sexual Function Index-6 (in females), respectively. All the participants were stented following the procedure, and the stent was removed after 3 weeks. Post-procedural sexual function and general discomfort were assessed and compared between three groups at 1 week, 3 weeks, and 12 weeks. The effect of surgery-related anxiety, preoperative sexual function, age, and general discomfort (including stent-related discomfort) on post-procedural sexual function were analyzed using multiple regression analysis. A p-value of less than 0.05 was considered statistically significant. Results: Totally, 327 eligible patients were randomized into three groups. The group of patients who underwent the procedural with a screen separating the operating area from the patient vision, while the patient could watch the endoscopy through a separate monitor, had better post-procedural sexual function compared to those who had total vision of the operating area as well as to those whose eyes were blocked. This difference was statistically significant. This post-procedural reduction in sexual function could not be attributed to in situ stent alone. Conclusions: Our study showed that semi-rigid ureterorenoscopy can have significant negative effect on sexual function, which can be reduced with proper preoperative counseling and an ideal operating room settings.

Evaluation of environmental impacts of cotton polo shirt production in Bangladesh using life cycle assessment.

The textile industry is widely considered as one of the most pollutant-releasing sectors globally. As the world is moving toward sustainability, it is essential to thoroughly assess how a textile product affects the environment. The aim of this study is to investigate the environmental impact of textile manufacturing in Bangladesh using life cycle assessment (LCA) method. A cradle-to-gate LCA was conducted to produce 1000 units of cotton polo shirts following ISO 14040 standards. LCA was also conducted for each final product at every manufacturing stage of cotton polo shirt, including the production of 1000 kg of cotton fibers, 1000 kg of yarn, 1000 kg of grey fabrics, 1000 kg of dyed-finished fabrics, and finally, assembling of 1000 pieces of polo shirts. Inventory analysis revealed that for producing 1000 pieces of polo shirts, 0.12 hector of land, 363.89 kg of cotton fiber, 324.84 kg of yarn, 320.45 kg of knitted fabric, and 299.5 kg of dyed-finished fabrics were required. The study also found that 1550.9 kWh of electricity, 15.47 L of diesel, and 72.54 m3 of natural gas were needed to produce 1000 pieces of polo shirts. The potential environmental impacts were categorized into 12 different types based on the CML 2001 method and calculated using openLCA 2.0 software. The outcomes of LCA revealed considerable environmental impacts in different categories during manufacturing of cotton polo shirts in Bangladesh. For example, the global warming potential (GWP) associated with the manufacturing of 1000 pieces of polo shirts was 1345.97 kg CO2-eq. Among several production stages of polo shirts, the highest contributor of GWP was dyeing section (38.36 %), followed by cotton fiber production (29.32 %) and yarn manufacturing (18.92 %). The obtained data also revealed that for cultivating cotton fibers, manufacturing of yarn and grey fabrics, and finally dyeing-finishing of same quantity fabric (1000 kg), the GWP were 1084.41 kg CO2-eq, 783.67 kg CO2-eq, 145.88 kg CO2-eq, 1723.88 kg CO2-eq, 314.94 kg CO2-eq, respectively. The outcome of the impact assessment will be crucial for decision-making when it comes to taking remedial actions to lessen negative environmental consequences for the sustainable development of textile industry in Bangladesh.

Poziotinib treatment in patients with HER2-positive advanced breast cancer who have received prior anti-HER2 regimens.

PURPOSE: Poziotinib is an irreversible pan-inhibitor of the human epidermal growth factor receptor (HER) that has shown acceptable tolerability and antitumor activity in phase I and II trials in patients with advanced solid tumors. In the present open-label, multicenter phase II study, we demonstrate safety, tolerability, and preliminary efficacy data from two different dosing schedules in patients with HER2-positive advanced breast cancer. PATIENTS AND METHODS: Patients who had received at least two prior HER2-directed therapy lines for advanced disease, received 24 mg poziotinib on an intermittent dosing schedule (cohort 1) or 16 mg poziotinib once daily on a continuous dosing schedule (cohort 2). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), disease control rate (DCR), and time to progression (TTP). Secondary endpoints additionally included safety and pharmacokinetics. RESULTS: A total of 67 patients were enrolled. The ORR was 30% in both groups (p = 0.98). DCR was 60% vs 78% (p = 0.15) and median PFS and TTP were 4.1 vs 4.9 months (both p = 0.30) for cohorts 1 and 2, respectively. The most common treatment related adverse events (AEs) of any grade included diarrhea (88% vs 85%, p = 0.76), rash (88% vs 88%, p = 0.96), and stomatitis (64% vs 56%, p = 0.52), with grade 3-4 diarrhea occurring in 33% vs 32% of patients (p = 0.93) and grade 3-4 rash in 27% vs 35% of patients (p = 0.48) in cohort 1 vs cohort 2, respectively. CONCLUSION: Poziotinib demonstrated evidence of clinical activity in patients with pre-treated HER2-positive advanced breast cancer, although high levels of toxicity may preclude further studies at this time.

Carbon nanofibers based carbon-carbon composite fibers.

Textile grade polyacrylonitrile (PAN) was used as a precursor material for carbon fiber preparation. E-beam irradiated polyacrylonitrile grafted carbon nanofibers were dispersed in polyacrylonitrile solution (dissolved in dimethyl formamide). Carbon nanofibers (CNF) infused polyacrylonitrile solution was wet spun on a lab-scale wet-spinning setup to form 50 to 70 µm diameter fibers with 3.2 wt.% CNF-PAN, 6.4 wt.% CNF-PAN, and neat PAN. Precursor fibers were characterized for thermal, mechanical and morphological properties using various techniques. Drawing the precursor fibers further enhanced polymer chain orientation and coalesced the voids, enhancing tensile strength and modulus by more than 150% compared to those of the undrawn fibers. Precursor composite fibers on carbonization showed enhanced strength, compared to that of pristine PAN fibers, by four times and stiffness by 14 times. The carbon-carbon composite fibers were further characterized with SEM/FIB, XRD and tensile strength. The property improvements were dependent on the uniform distribution of carbon nanofibers, and surface modification of carbon nanofibers further enabled their dispersion in the composite fibers. Furthermore, 3.2 wt.% CNFs in PAN fibers showed maximum improvement in properties compared to 6.4 wt.% CNF in PAN fibers, indicating that the property enhancements go through a maximum and then drop off due to challenge in getting uniform distribution of nanofibers.

Poziotinib in Treatment-Naive NSCLC Harboring HER2 Exon 20 Mutations: ZENITH20-4, A Multicenter, Multicohort, Open-Label, Phase 2 Trial (Cohort 4).

INTRODUCTION: ERBB2 or HER2 alterations are found in approximately 2% to 5% of NSCLCs; most are exon 20 insertion mutations. The efficacy and safety of poziotinib, an oral tyrosine kinase inhibitor, were assessed in patients with treatment-naive NSCLC whose tumors harbor HER2 exon 20 insertions. METHODS: ZENITH20 is an open-label, multicohort, multicenter, global, phase 2 trial. ZENITH20-C4 enrolled treatment-naive patients with NSCLC with tumors harboring HER2 exon 20 insertions. Poziotinib was administered 16 mg once daily (QD) or 8 mg twice daily (BID). The primary end point was objective response rate (ORR) by independent central review. Secondary and exploratory end points included disease control rate, duration of response, progression-free survival, and safety. RESULTS: A total of 80 patients (16 mg QD, n = 47; 8 mg BID, n = 33) were treated in ZENITH20-C4. ORR was 39% (95% confidence interval [CI]: 28%-50%; 31 of 80), with a disease control rate of 73% (95% CI: 61%-82%; 58 of 80); 80% of the patients experienced tumor reduction. Median duration of response was 5.7 (95% CI: 4.6-11.9) months, and median progression-free survival was 5.6 (95% CI: 5.4-7.3) months. The most common grade 3 treatment-related adverse events were rash (QD, 45%; BID, 39%), stomatitis (QD, 21%; BID, 15%), and diarrhea (QD, 15%; BID, 21%). Among all subtypes of HER2 exon 20 insertions, seven patients (9%) harboring tumors with G778_P780dupGSP had the best clinical outcomes (ORR, 71%). CONCLUSIONS: Poziotinib was found to have clinically meaningful efficacy with a manageable toxicity profile for patients with treatment-naive NSCLC harboring HER2 exon 20 mutations.

Sexually Induced Orgasm to Improve Postpartum Pelvic Floor Muscle Strength and Sexual Function in Primiparous Women After Vaginal Delivery: A Prospective Randomized Two-Arm Study.

BACKGROUND: Postpartum pelvic floor dysfunction is known to affect the quality of life of women and the methods to treat it are more complex with majority requiring training under supervision. AIM: To compare the efficacy of sexually induced orgasm along with Kegels exercises versus Kegels exercises alone as a treatment method to enhance postpartum pelvic floor muscle strength and sexual function in primiparous women undergoing uncomplicated vaginal deliveries. METHODS: The prospective randomized two-arm study was conducted on sexually active primiparous women who had undergone uncomplicated vaginal deliveries. Those with risk factors for female sexual dysfunction and pelvic floor muscle dysfunction were excluded. Participants in Group 1 were advised daily Kegel's exercises, whereas, those in Group 2 were advised to initiate self-initiated/partnered sexual activity-induced orgasms along with daily Kegel's exercises. Their pelvic floor muscle strength on voluntary contraction, ability to relax pelvic floor voluntarily, and sexual function (using FSFI-6) were assessed monthly for 6 months and the analysis was done using G* Power software (© 2021 Heinrich-Heine-Universität Düsseldorf, Germany). MAIN OUTCOME MEASURE: Postpartum pelvic floor strength and sexual function in 2 groups of women under study. RESULTS: The study period was from January 2020 to December 2020. The Group 1 had 26 participants (mean age 29.69 ± 2.2 years) and Group 2 had 29 participants (mean age 30.07 ± 2.57 years). The sexual function as well as ability to relax pelvic floor were significantly better in Group 2 compared to Group 1 at each monthly intervals whereas strength of pelvic floor muscles during voluntary contraction was significantly higher in Group 2 compared to Group 1 at the end of 6 months and it was statistically significant at a P value of .05. CLINICAL IMPLICATIONS: Novel method of using naturally occurring sexually induced orgasms for postpartum pelvic floor rehabilitation can revolutionize postpartum pelvic floor training in women, as it can be practiced at home with ease, along with easily performable Kegel's exercises. STRENGTHS AND LIMITATIONS: Use of prospective randomization and minimization of confounding factors is the strength of the study. The small sample size is the limitation of the study. CONCLUSIONS: Postpartum pelvic floor muscle strength and sexual function in primiparous women who have undergone uncomplicated vaginal deliveries can be significantly improved with the addition of sexually induced orgasm as a therapeutic tool along with physical exercises such as Kegels exercises in these women. Bhat GS, Shastry A. Sexually Induced Orgasm to Improve Postpartum Pelvic Floor Muscle Strength and Sexual Function in Primiparous Women After Vaginal Delivery: A Prospective Randomized Two-Arm Study. J Sex Med 2022;19:1634-1643.

Validation of holding time, a novel tool to assess control over ejaculation in males: A pilot study.

Premature ejaculation (PE) is considered as a disorder of perceived loss of ejaculatory control. However, we cannot objectively estimate ejaculatory control due to the absence of an objective tool to measure it. Hence, we designed a pilot study to validate holding time (HoT), a novel objective tool, hypothesized by us, to measure ejaculatory control in men. The construct validity of this tool to differentiate premature ejaculators from normal ejaculators was also assessed in our sample. The study sample had 10 healthy, sexually active normal ejaculators, and 10 premature ejaculators, who volunteered to participate in the study conducted from May 2020 to April 2021. The mean HoT in normal ejaculators was 120.2 ± 31.7 s and the same in premature ejaculators was 32.9 ± 12.9 s. Both the normal (r = 0.983) as well as premature ejaculators (r = 0.839) had good test-retest reliability. The construct validity of HoT to diagnose PE was good with 90% sensitivity, 91% specificity, 63.8% positive predictive value, and 98.1% negative predictive value to diagnose PE when compared with diagnosis by a standard tool. It could be concluded that HoT successfully measured ejaculatory control in men and differentiated normal ejaculators from the premature ejaculators in the sample studied.

Case Report: Exceptional Response to Poziotinib in Patient with Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutation.

Among the several next-generation tyrosine kinase inhibitors (TKIs) tested against uncommon EFGR alterations, poziotinib has been demonstrated to be a powerful agent for metastatic non-small-cell lung cancer (mNSCLC) with aberrations in HER2 exon 20, and FDA approval is being sought in the previously-treated population. Poziotinib has also shown activity in mNSCLC with aberrations in EGFR exon 20. Herein, we report the first published case of a patient affected by mNSCLC harbouring an EGFR exon 20 insertion (EGFRex20ins) mutation who achieved a complete response (CR) under treatment with poziotinib as part of the ZENITH20 trial. In January 2021, a former smoker 62-year-old female patient was diagnosed with relapse, after two surgeries and post-operative chemotherapy of mNSCLC, at liver and retroperitoneal nodes. Given the identification by Next Generation Sequencing (NGS) of EGFRex20ins mutation, she was enrolled in ZENITH20-cohort 5 trial, a phase 2 multicentre study aimed to assess the efficacy and safety of poziotinib in patients with EGFR or HER2 exon 20 insertion mutations. Poziotinib as first-line systemic therapy for metastatic disease was initiated at the end of January 2021 and administrated at the initial dosage of 8 mg orally twice daily (BID). The most common side effects from the beginning of the treatment included alopecia, macular skin rash, diarrhoea, xerostomia, and conjunctivitis. Due to these adverse events, poziotinib was discontinued during the first 3 months and then reduced to 6 mg orally BID in April 2021. After the dose de-escalation, the adverse events ameliorated, and the patient better tolerated the treatment without further interruption. Since the first reevaluation (after 4 weeks of therapy), the treatment with poziotinib resulted to be remarkably effective, with a partial response (PR) subsequently confirmed in May and July 2021. Then, in October 2021, a CT scan confirmed a CR, maintained with good tolerance at the last reevaluation in February 2022. Treatment is still ongoing at the same dosage. In this case, poziotinib has represented a successful and well-tolerated first-line treatment alternative to chemotherapy in this patient with EGFR exon 20 insertion mutated mNSCLC.

Poziotinib in Non-Small-Cell Lung Cancer Harboring HER2 Exon 20 Insertion Mutations After Prior Therapies: ZENITH20-2 Trial.

PURPOSE: Insertion mutations in Erb-b2 receptor tyrosine kinase 2 gene (ERBB2 or HER2) exon 20 occur in 2%-5% of non-small-cell lung cancers (NSCLCs) and function as an oncogenic driver. Poziotinib, a tyrosine kinase inhibitor, was evaluated in previously treated patients with NSCLC with HER2 exon 20 insertions. METHODS: ZENITH20, a multicenter, multicohort, open-label phase II study, evaluated poziotinib in patients with advanced or metastatic NSCLC. In cohort 2, patients received poziotinib (16 mg) once daily. The primary end point was objective response rate evaluated by independent review committee (RECIST v1.1); secondary outcome measures were disease control rate, duration of response, progression-free survival, and safety and tolerability. Quality of life was assessed. RESULTS: Between October 2017 and March 2021, 90 patients with a median of two prior lines of therapy (range, 1-6) were treated. With a median follow-up of 9.0 months, objective response rate was 27.8% (95% CI, 18.9 to 38.2); 25 of 90 patients achieved a partial response. Disease control rate was 70.0% (95% CI, 59.4 to 79.2). Most patients (74%) had tumor reduction (median reduction 22%). Median progression-free survival was 5.5 months (95% CI, 3.9 to 5.8); median duration of response was 5.1 months (95% CI, 4.2 to 5.5). Clinical benefit was seen regardless of lines and types of prior therapy, presence of central nervous system metastasis, and types of HER2 mutations. Grade 3 or higher treatment-related adverse events included rash (48.9%), diarrhea (25.6%), and stomatitis (24.4%). Most patients had poziotinib dose reductions (76.7%), with median relative dose intensity of 71.5%. Permanent treatment discontinuation because of treatment-related adverse events occurred in 13.3% of patients. CONCLUSION: Poziotinib demonstrates antitumor activity in previously treated patients with HER2 exon 20 insertion NSCLC.

Defining ejaculatory latencies in heterosexual males using novel tools in all types of sexual encounters in multinational population sample.

Research into ejaculatory dysfunction in sexual activities other than penovaginal intercourse is limited due to the absence of well-defined tools to measure ejaculatory latencies in these sexual activities. Our pilot study using Arousal to Ejaculation Time Interval (AETI) and Erection to Ejaculation Time Interval (EETI) as tools to measure ejaculatory latencies in different types of sexual encounters in medical professionals had yielded promising results. Hence, we conducted a similar study using AETI and EETI as tools, measured using stopwatch in healthy, sexually active heterosexual male population in a multinational sample from January 2018 to December 2020. Though mean AETI and EETI differed in different sexual activities, on analysing them across all sexual activities, mean AETI and EETI in normal ejaculators, premature ejaculators and delayed ejaculators were 10.3 ± 5.81 min and 6.8 ± 4.13 min, 4.31 ± 2.98 min and 3.35 ± 3.06 min and 20.9 ± 16.1 min and 16.3 ± 10.6 min respectively. Both AETI and EETI were significantly different from normal to premature as well as normal to delayed ejaculators (p-value < 0.05). It could be concluded that these novel tools can help to measure ejaculatory latencies in sexual activities in heterosexual males.

Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma.

BACKGROUND: Belinostat is a histone deacetylase inhibitor approved for relapsed refractory peripheral T-cell lymphoma (PTCL). The primary objective of this study was to determine the maximum tolerated dose (MTD) of belinostat combined with CHOP (Bel-CHOP). Secondary objectives included safety/tolerability, overall response rate (ORR), and belinostat pharmacokinetics (PK). METHODS: Patients were ≥ 18 years with histologically confirmed, previously untreated PTCL. Patients received belinostat (1000 mg/m2 once daily) + standard CHOP for 6 cycles with varying schedules using a 3 + 3 design in Part A. Part B enrolled patients at MTD dose. RESULTS: Twenty-three patients were treated. One patient experienced DLT (Grade 3 non-hematologic toxicity) on Day 1-3 schedule, resulting in escalation to Day 1-5 schedule (n = 3). No DLTs were observed and Day 1-5 schedule with 1000 mg/m2 was declared as MTD. Twelve additional patients were enrolled in Part B using MTD. Median relative dose intensity was 98%. All patients experienced adverse events (AEs), including nausea (78%), fatigue (61%), and vomiting (57%). Serious AEs occurred in 43%, with febrile neutropenia (17%) and pyrexia (13%). Overall ORR was 86% with 71% reported CR at MTD. Belinostat PK parameters were similar to single-agent. CONCLUSIONS: Bel-CHOP was well tolerated and MTD in CHOP combination was the same dose and schedule as single agent dosing. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01839097.

A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): A Phase 3 study.

Eflapegrastim (Rolontis® ) is a novel, long-acting hematopoietic growth factor consisting of a recombinant human granulocyte-colony stimulating factor (rhG-CSF) analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. We report results from a second pivotal, randomized, open-label, Phase 3 study comparing the efficacy and safety of eflapegrastim to pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia. Patients with Stage I to IIIA early-stage breast cancer (ESBC) were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or pegfilgrastim (6 mg G-CSF) administered one day after standard docetaxel/cyclophosphamide (TC) therapy for four cycles. The primary objective was to demonstrate noninferiority (NI) of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN; Grade 4) in Cycle 1. A total of 237 eligible patients were randomized 1:1 to receive either eflapegrastim (n = 118) or pegfilgrastim (n = 119). Cycle 1 severe neutropenia was observed in 20.3% (n = 24) of patients receiving eflapegrastim and 23.5% (n = 28) receiving pegfilgrastim. The DSN of eflapegrastim in Cycle 1 was noninferior to pegfilgrastim with a mean difference of -0.074 days (NI P-value < .0001). Noninferiority was maintained throughout the four treatment cycles (P < .0001 in all cycles). Other efficacy endpoints results were comparable between treatment arms, and adverse events, irrespective of causality and grade, were comparable between treatment arms. The results demonstrate noninferior efficacy and comparable safety for eflapegrastim, at a lower G-CSF dose, vs pegfilgrastim. The potential for the increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study.

Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial.

BACKGROUND: Eflapegrastim, a novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open-label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia. MATERIALS AND METHODS: Patients with early-stage breast cancer were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim (6 mg G-CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1. RESULTS: Eligible patients were randomized 1:1 to study arms (eflapegrastim, n = 196; pegfilgrastim, n = 210). The incidence of cycle 1 severe neutropenia was 16% (n = 31) for eflapegrastim versus 24% (n = 51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (-0.148 day) met the primary endpoint of noninferiority (p < .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms. CONCLUSION: These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G-CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN. IMPLICATIONS FOR PRACTICE: Chemotherapy-induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, the efficacy of eflapegrastim was noninferior to pegfilgrastim and had comparable safety. Nevertheless, the risk of CIN remains a great concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.

Time to Orgasm in Women in a Monogamous Stable Heterosexual Relationship.

BACKGROUND: Orgasm in women is a complex phenomenon, and the sparse data about time to orgasm (TitOr) in women are an impediment to the research on this complex phenomenon. AIM: To evaluate the stopwatch measured TitOr in women in a monogamous stable heterosexual relationship. METHODS: The study was conducted through web-based and personal interview using a questionnaire, which addressed the issues related to TitOr. Sexually active women older than 18 years and women in a monogamous stable heterosexual relationship were included in the study. Those with comorbidities such as diabetes, hypertension, asthma, psychiatric illness, sexual dysfunction and those with partners with sexual dysfunction were excluded. The participants reported stopwatch measured TitOr after adequate sexual arousal over an 8-week period. The data analysis was performed using GraphPad software (©2018 GraphPad Software, Inc, USA). OUTCOMES: The outcomes included stopwatch measured average TitOr in women. RESULTS: The study period was from October 2017 to September 2018 with a sample size of 645. The mean age of the participants was 30.56 ± 9.36 years. The sample was drawn from 20 countries, with most participants from India, the United Kingdom, the Netherlands, and the United States of America. The mean reported TitOr was 13.41 ± 7.67 minutes (95% confidence interval: 12.76 minutes-14.06 minutes). 17% of the participants had never experienced the orgasm. Penovaginal intercourse was insufficient to reach orgasm in the majority, in whom it was facilitated by certain positions and maneuvers. CLINICAL IMPLICATIONS: The knowledge of stopwatch measured TitOr in women in real-life setting helps to define, treat, and understand female sexual function/dysfunction better and it also helps to plan treatment of male ejaculatory dysfunction, as reported ejaculatory latency in healthy men is much less than the reported TitOr here. STRENGTHS & LIMITATIONS: Use of stopwatch to measure TitOr and a large multinational sample are the strength of the study. The absence of a crosscheck mechanism to check the accuracy of the stopwatch measurement is the limitation of the study. CONCLUSION: Stopwatch measured average TitOr in the sample of women in our study, who were in a monogamous stable heterosexual relationship, is 13.41 minutes (95% confidence interval: 12.76 minutes-14.06 minutes) and certain maneuvers as well as positions during penovaginal intercourse help achieving orgasm, more often than not. Bhat GS, Shastry A. Time to Orgasm in Women in a Monogamous Stable Heterosexual Relationship. J Sex Med 2020;17:749-760.

A prospective double-blind, randomized, placebo-controlled study to evaluate the efficacy of silodosin 8 mg as an on-demand, reversible, nonhormonal oral contraceptive for males: a pilot study.

PURPOSE: As silodosin 8 mg, used for treating BPH, is known to cause absence of sperms in the ejaculate, its potential as an on-demand, reversible, nonhormonal oral contraceptive for males was assessed in this pilot study. METHODS: In this randomized, double-blind, placebo-controlled pilot study, healthy, sexually active adult male volunteers in a stable sexual relationship with a female partner with proven fertility were recruited. Those using other contraceptive methods were excluded. During the first part of the study, silodosin 8 mg and placebo were crossed over among the randomly assigned two groups of participants and their post-masturbation semen and post-ejaculation urine were analyzed for spermatozoa. During the second part, both groups received silodosin 8 mg 3 h prior to heterosexual vaginal intercourse for 1 year. The primary outcome measure was the number of unintended pregnancies in their female partners. The secondary outcome measure was dropout rate due to adverse events. The clinical trial registry number was CTRI/2017/09/009872. RESULTS: The study period was January 2017 to December 2017 with sample size 63. Reversible azoospermia was noted following silodosin intake during the first part of the study. During the second part, no untended pregnancy was reported. None of the participants dropped out due to adverse events. Four patients were lost to follow-up. CONCLUSIONS: Silodosin 8 mg achieved total reversible azoospermia, hence prevented unintended pregnancies in the female partners of the males who used the drug as an on-demand oral contraceptive.

Environmentally-friendly thermal and acoustic insulation materials from recycled textiles.

Continuing increase in energy consumption and environmental pollution are some of the main challenges of the 21st century. One of the approaches to overcome these challenges is to increase the use of recycled materials and environmentally-friendly approaches to manufacturing. Thermal and acoustic insulation in buildings and transport vehicles from recycled textiles can play an important role in energy savings and reduction of environmental pollution. Textiles contribute a significant amount to the waste stream since most of these valuable fiber products are discarded after use. These discarded but valuable textiles can be recycled to produce several products including thermal and acoustic insulation materials. In this paper, a comprehensive review of the current state of textile waste generation and its environmental effects, and present progress of using industrial and post-consumer recycled textiles in insulation materials is provided. Mechanism of acoustic and thermal insulation materials of textile fibers are also reviewed. Existing research of some textile waste used as building insulation materials, method of conversion of textile waste into building insulation materials, comparative analysis of different insulation materials and life cycle assessment of textile fibers are assessed.

Association Between Post-Ejaculatory Refractory Time (PERT) and Premature Ejaculation (PE).

INTRODUCTION: Patients with premature ejaculation (PE) often complain of difficulty in having second erection, which is not yet investigated using scientific methodology. AIM: Evaluation of the association between post-ejaculation refractory time (PERT) with PE by comparing PERT in premature ejaculators with their age-matched control subjects. METHODS: After ethical committee approval and written informed consent from the participants were obtained, men in a monogamous stable sexual relationship and reporting PE were recruited into the study. Sexually active, matched control subjects were recruited for comparison. Exclusion criteria were erectile dysfunction, diabetes mellitus, cardiovascular diseases, hypogonadism, psychiatric conditions, instrumentation of the genitourinary tract, genitourinary anomalies, and genitourinary infections. Both the premature ejaculators and their control subjects were evaluated with the PE diagnostic tool before initiation of the study. They were asked to record their IELT and PERT over 4 weeks. The statistical analysis was done to obtain descriptive statistics, namely, mean and SD, paired t-tests, and logistic regression analysis. P < .001 was considered significant. MAIN OUTCOME MEASURE: There was a statistically significant association between prolonged PERT and PE in patients with PE compared with their age-matched control subjects. RESULTS: 102 premature ejaculators and an equal number of matched control subjects were evaluated from January 2016-December 2017. The average PERT in premature ejaculators and control subjects was 330 ± 296.63 minutes and 105.64 ± 98.59 minutes, respectively (P < .0001). Increasing age was associated with increasing PERT. PE was more common in patients when PERT exceeded a threshold of 590 minutes. CLINICAL IMPLICATIONS: Until now, the association between PE and PERT with matched-pair analysis was not reported. Our study addresses this association, which can add a new paradigm in the evaluation and management of PE. STRENGTH & LIMITATIONS: The association between PE and prolonged PERT using a statistically appropriate, adequately powered methodology is the strength of the study. The inability to address the causal association between prolonged PERT and PE because of the paucity of evidence at present is the limitation of the study. We believe that the results of this study could trigger further research into such an association, so the mystery of such an association can be unraveled. CONCLUSIONS: The association between prolonged PERT and PE, as seen in our study, is a finding, that needs further research to establish a causal association. However, reporting such an association is necessary because it is contrary to the present understanding. Bhat GS, Shastry A. Association Between Post-Ejaculatory Refractory Time (PERT) and Premature Ejaculation (PE). J Sex Med 2019;16:1364-1370.

Idiopathic renal replacement lipomatosis: A diagnostic and therapeutic challenge.

Renal replacement lipomatosis is a rare benign renal disorder where the renal parenchyma is replaced by mature fatty tissue. It poses a diagnostic challenge to the clinicians due to an unusual presentation and clinical features. The disease usually presents in middle age with vague pain in the affected flank and variable urological symptoms. Although the condition is preceded by calculus disease or chronic inflammation, as an extremely rare occurrence, it can occur without any pre-existing condition, as in our case. Increasing awareness among the surgeons about the existence of such a condition will help the surgical fraternity to diagnose and manage such cases properly.