Revolutionizing Overactive Bladder Treatment: Digital Conversational Agent Offers Promising Results

In a pioneering study conducted by Renalis University Hospitals in Cleveland, Ohio, a novel approach to treating overactive bladder (OAB) has emerged with the use of a digital conversational agent named CeCe. They found that CeCe’s role as a digital conversational agent emerged as a promising solution, effectively alleviating the severity of OAB symptoms and enhancing the overall quality of life for patients.

The study results were published in the journal UroGynecology. 

Overactive bladder (OAB) syndrome stands as a persistent medical condition significantly impacting the quality of life for a considerable portion of the population. It disrupts the activities of daily living and many individuals refrain from seeking medical assistance. As conservative therapy is effective in the management of overactive bladder, researchers conducted a prospective observational trial to evaluate the efficacy of digital conversational agents for the treatment of Overactive bladder.

In this prospective observational trial, a digital conversational agent developed by Renalis University Hospitals in Cleveland, Ohio, was employed for OAB treatment. Patients accessed CeCe over 8 weeks, receiving guidance on bladder training, pelvic floor exercises, and comprehensive information on bladder health. The primary objective was to assess a reduction in the International Consultation on Incontinence—Overactive Bladder Quality-of-Life Questionnaire (ICIQ-OAB-QoL) score from week 1 to week 8. Additionally, patients completed the 36-item Short-Form Health Survey and Generalized Anxiety Disorder Questionnaire at the same intervals, along with voiding diaries at weeks 1, 4, and 8. A power analysis indicated that a total of 30 patients were necessary to demonstrate a significant difference in symptom scores post-CeCe use, with 80% power and an α error of 5%.

Findings:

  • All data collection was completed by 29 patients. There was a significant difference in ICIQ-OAB-QoL scores between weeks 1 and 8 (62 [IQR], 49–75) compared to 32 [IQR, 24–43]; P < 0.001).
  • Patients also noted a decrease in frequency before and after treatment (7 [IQR, 6–10] vs. 5 [IQR, 4–7]; P = −0.04), diminished nocturia (2 [IQR, 1–3] vs. 1 [IQR, 1–2]; P = 0.03), and a substantial reduction in urge urinary incontinence (2 [IQR, 1–5] vs. 0 [IQR, 0–3]; P = 0.04).
  • Additionally, a noteworthy decline in alcohol consumption from 24 oz [IQR, 12–36 oz) in week 1 to 14 oz (IQR, 9–22 oz]; P = 0.02) in week 8 was noted.
    Thus, utilizing a digital conversational agent effectively alleviated symptom severity and enhanced the quality of life for individuals with OAB. This innovative approach not only addresses accessibility concerns associated with traditional OAB treatments but also introduces a potentially transformative solution for individuals seeking effective and accessible care.
    This study marks a significant step towards the integration of digital tools in healthcare, offering hope to individuals facing chronic conditions and accessibility challenges. CeCe’s impact on OAB patients underscores a promising shift towards a more inclusive and personalized healthcare paradigm.
    Further reading: Sheyn, David MD, et al. Use of a Digital Conversational Agent for the Management of Overactive Bladder. Urogynecology ():10.1097/SPV.0000000000001428, November 6, 2023. | DOI: 10.1097/SPV.0000000000001428

    Powered by WPeMatico

    Aurobindo Pharma Telangana facility gets USFDA EIR

    Hyderabad: Aurobindo Pharma has announced that Unit VI-B, a Formulation manufacturing facility of the Company, situated at Chitkul Village, Patancheru Mandal, Sangareddy District, Telangana, has received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) classifying the facility as “Voluntary Action Indicated” (“VAI”).

    VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

    The USFDA had inspected the facility from September 22 to September 29, 2023 and issued one observation.

    Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. The company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

    Read also: Aurobindo Pharma arm bags USFDA nod for Posaconazole Injection

    Powered by WPeMatico

    Focus On: Co-prescribing Probiotics and Prebiotics with PPIs in India – Five Commandments

    Published in the latest December issue of JAPI, the survey included 1007 health care professionals (HCPs) from across India. Based on consensus results, panelists recommended five commandments.

    1. Perform a thorough clinical evaluation before prescribing PPIs (level 1)

    2. Prescribe PPIs for a short-term duration (≤8 weeks). If long-term therapy is prescribed, reassess the need for continuation periodically and attempt to taper or discontinue if possible (level 2)

    3. Educate patients about potential side effects associated with long-term PPI use, especially abnormal bowel habits, bloating, micronutrient deficiencies, flatulence, and abdominal pain (level 2)

    4. Co-prescribe pre- and probiotics with PPIs when managing patients with Antibiotic-associated diarrhoea, and those experiencing abnormal bowel habits, bloating (level 1), micronutrient deficiencies, flatulence, and abdominal pain (level 2)

    5. Consider co-prescribing pre- and probiotics for >3 months to achieve favorable outcomes and improve overall quality of life (level 1), while monitoring and assessing their effectiveness regularly.

    PPI: proton-pump inhibitor

    Level 1: >50% agreed; level 2: 30-50% HCPs agreed

    Adapted from:

    Kalra S et al. The Scope of Pre- and Probiotics as an Add-on to Proton-pump Inhibitors in Various Clinical Indications. J Assoc Physicians India 2023;https://doi.org/10.59556/ japi.71.0409

    Powered by WPeMatico

    Doctor-Pharma Nexus: GMSH Medical officer repatriated to Haryana

    Chandigarh: In response to receiving multiple complaints against a doctor accused of having a nexus with a local pharmaceutical company/ brand, the UT health department on Friday repatriated a medical officer at Government Multi-Specialty Hospital (GMSH), Sector 16.

    The doctor serving in the Department of Orthopaedics was sent back to his home cadre in Haryana after accusations emerged that he had prescribed medicines of a pharmaceutical company/brand to patients at the hospital for commission. 

    A private news channel recently uncovered this incident through a sting operation conducted at the hospital, which exposed the nexus between the accused doctor and a medical representative. 

    Also read- Doctors Should Write Generic, Non-Proprietary, Pharmacological Names Only: NMC Prescription Guidelines

    It was discovered that the accused doctor had allegedly been prescribing locally produced medications in return for a commission. The evidence, captured on camera, included a medical representative’s claim that the doctor had received an advance payment of ₹50,000, HT reports.

    According to a TOI news report, the UT health department investigated the allegations of the doctor to gather evidence that revealed repeated transactions of money from a person to the wife of the doctor in GMSH-16. However, an official inquiry into the matter remains pending. 

    Following this, an official order was released by UT health secretary Ajay Chagti which mentioned: “Dr ***, presently working as medical officer (ortho) in UT health department, on deputation basis from the state of Haryana, is hereby repatriated/relieved to his parent state with immediate effect on administrative grounds.”

    “Disciplinary action will be recommended after a detailed inquiry into the matter. I have also requested SP vigilance to probe the case under the Prevention of Corruption Act,” reads the order.

    Medical Dialogues team had earlier reported that the Union Government completely curtailed the visits of pharma company Medical Representatives (MRs) to Government Hospital premises. Besides this, the Government strictly stipulated that information about any new launch should be communicated via email.

    This action was taken because all doctors across the country were mandated by the erstwhile Medical Council of India (now the National Medical Commission (NMC)) to prescribe generic medicines only. However, the Central Government noted that in various Central Government Hospitals/CGHS Wellness Centers/ Polyclinics there were many doctors (including Residents) who continued to prescribe branded medicines.

    The Government has been working on cracking down on the unethical doctor-pharma nexus for long and had earlier suspended two central government health scheme (CGHS) doctors for allegedly prescribing certain medicines in favour of a particular pharmaceutical company.

    Speaking to TOI, Chagti further said, “The health department is taking short-term measures at its level. In the medium term, it will contemplate reforms related to transparency.”

    Also read- Central Govt Full Stop To Doctor-Pharma Nexus- Curtails MR Visits In Govt Hospitals

    Powered by WPeMatico

    Cipla, Kemwell Biopharma, Manipal forge cell therapy alliance in US

    Mumbai: Cipla (EU) Limited, UK a wholly owned subsidiary of Cipla
    Limited, hereinafter referred to as Cipla has announced a
    strategic collaboration with Kemwell Biopharma Private Limited (through its subsidiary
    Kemwell Biopharma UK Limited) and Manipal Education & Medical Group (through its
    subsidiary MNI Ventures, Mauritius) to incorporate a joint venture in the United States.

    The
    primary goal of this joint venture is to develop and commercialise novel Cell therapy
    products for major unmet medical needs in the United States, Japan, and EU regions.
    Cipla (EU) Limited will secure a 35.2% stake in the joint venture company.

    “By capitalizing
    on Cipla’s leadership in product development and commercialisation and aligning with
    Kemwell’s expertise in biologics and Manipal’s expertise in healthcare delivery, this
    strategic collaboration is aimed at expediting development, manufacturing, licensing,
    import and export of cutting-edge Cell therapy products to cater to patients globally,” the release stated.

    Commenting on this development, Umang Vohra, Managing Director & Global Chief
    Executive Officer, Cipla, said, “This joint venture reinforces our concerted efforts to move
    up the innovation curve and pioneer transformative treatments in the areas of stem cell
    and CAR T-cell therapies, enabled by advances in biotech, mRNA and cell-engineering
    research, that can make a difference to patient lives globally. As we steer Cipla into the
    future and lead with purpose, our partnership with Kemwell and Manipal Group will be
    integral in realising these advancements.”

    Commenting on the tie up, Dr Ranjan Pai, Chairman, Manipal Education & Medical
    Group, said, “We are very happy to partner with Cipla and Kemwell in bringing the next
    generation of biological therapies to address unmet medical needs globally. Physicians
    will have accessible, safe, and clinically effective Cell therapies in their hand to fight
    against many serious indications. We believe that Cell therapy products will be a gamechanger in offering an advanced therapeutic treatment for millions of patients suffering
    with painful diseases.”

    Anurag Bagaria, Chairman and CEO, Kemwell added “We believe that Cell therapies will
    become a major branch of medical treatment and will become a standard of care for
    challenging diseases. Kemwell has built a world-class cGMP facility in Bangalore and
    made India an emerging hub for cell therapy development and manufacturing. The
    synergistic combinations of Cipla, Manipal and Kemwell will accelerate the
    development of novel cell-based products for patients and transform the new JV into a
    global player in cell therapeutics.”

    This marks the second joint venture between Cipla and Kemwell Biopharma, following
    the incorporation of Aspergen Inc., USA in 2022 for the development, manufacturing, and
    commercialization of biosimilars for global markets. Aspergen Inc. is actively developing
    two projects, with several others under evaluation.

    Powered by WPeMatico

    Low vitamin D levels associated with increased cardiovascular disease risk in young adults

    Low vitamin D levels associated with increased cardiovascular disease risk in young adults suggests a new study published in the Journal of Endocrinological Investigation.

    Vitamin D deficiency is related to metabolic disturbances. Indeed, a poor vitamin D status has been usually detected in patients with cardiovascular disease (CVD). However, the relationship between vitamin D and CVD risk factors in young adults remains controversial at present. This study aimed to examine the association between circulating 25-hydroxyvitamin D (25(OH)D) and CVD risk factors in young adults. The present cross-sectional study included a cohort of 177 young adults aged 18-25 years old (65% women). 25(OH)D serum concentrations were assessed using a competitive chemiluminescence immunoassay. Fasting CVD risk factors (i.e., body composition, blood pressure, glucose metabolism, lipid profile, liver, and inflammatory markers) were determined by routine methods. A panel of 63 oxylipins and endocannabinoids (eCBs) was also analyzed by targeted metabolomics. Results: Circulating 25(OH)D concentrations were inversely associated with a wide range of CVD risk factors including anthropometrical (all P ≤ 0.005), body composition (all P ≤ 0.038), glucose metabolism (all P ≤ 0.029), lipid profile (all P < 0.035), liver (all P ≤ 0.011), and pro-inflammatory biomarkers (all P ≤ 0.030). No associations of serum 25(OH)D concentrations were found with pro-inflammatory markers (all P ≥ 0.104), omega-6 and omega-3 oxylipins, nor eCBs concentrations or their analogues (all P ≥ 0.05). The present findings support the idea that 25(OH)D could be a useful predictor of CVD risk in young individuals.

    Reference:

    Amaro-Gahete FJ, Vázquez-Lorente H, Jurado-Fasoli L, Dote-Montero M, Kohler I, Ruiz JR. Low vitamin D levels are linked with increased cardiovascular disease risk in young adults: a sub-study and secondary analyses from the ACTIBATE randomized controlled trial. J Endocrinol Invest. 2024 Jan 4. doi: 10.1007/s40618-023-02272-4. Epub ahead of print. PMID: 38172418.

    Keywords:

    Low vitamin D, vitamin levels, cardiovascular disease, risk, young adults, Amaro-Gahete FJ, Vázquez-Lorente H, Jurado-Fasoli L, Dote-Montero M, Kohler I, Ruiz JR, 25-hydroxyvitamin D; Cardiovascular risk; Inflammation; Oxylipins; Young adults

    Powered by WPeMatico

    Mean Platelet Volume independently Linked to Mortality among Peritoneal Dialysis Patients

    In a groundbreaking exploration at the intersection of platelet volume and patient outcomes, a recent study has illuminated the potential role of mean platelet volume (MPV) as a significant indicator of mortality risks in individuals undergoing peritoneal dialysis (PD). While MPV has previously been associated with severity and mortality in sepsis patients, this study expands its relevance to the realm of renal care. The study found that MPV is independently associated with both all-cause mortality and cardiovascular mortality in patients undergoing peritoneal dialysis.

    The study results were published in the journal BMC Cardiovascular Diseases. 

    In the realm of medical research, the mean platelet volume (MPV) has emerged as a valuable indicator, demonstrating associations with severity and all-cause mortality in patients with sepsis. However, a recent study has delved into uncharted territory, exploring the relationship between MPV and all-cause mortality, as well as cardiovascular mortality, in patients undergoing peritoneal dialysis (PD). The primary objectives of this retrospective study were to uncover the potential links between MPV and both all-cause mortality and cardiovascular mortality among patients treated with PD.

    Researchers retrospectively gathered data from 1,322 patients undergoing PD between November 1, 2005, and August 31, 2019. The study’s primary outcomes were identified as all-cause mortality and cardiovascular mortality. To classify MPV, the researchers employed the X-tile software. The correlation between MPV and mortality was assessed using Cox models, and survival curves were generated using the Kaplan-Meier method.

    Key Findings:

    • The median follow-up period for the study participants was 50 months (ranging from 30 to 80 months), during which a total of 360 deaths were recorded.
    • For all-cause mortality, patients with MPV ≥ 10.2 fL exhibited a significantly higher risk across three different models.
    • Furthermore, PD patients with MPV ≥ 10.2 fL demonstrated a notably elevated risk of cardiovascular mortality in all three models.

    This groundbreaking study concludes that MPV is independently associated with both all-cause mortality and cardiovascular mortality in patients undergoing peritoneal dialysis. These findings offer valuable insights into the potential role of MPV as a prognostic marker for mortality risks in the context of PD. 

    The implications of this research extend beyond the specific patient population studied, prompting further exploration of MPV as a potential biomarker in other medical contexts. As the scientific community continues to uncover the intricate relationships between platelet volume and health outcomes, these findings open new avenues for understanding and managing mortality risks in diverse patient groups.

    Further reading: Mean platelet volume and the association with all-cause mortality and cardiovascular mortality among incident peritoneal dialysis patients. https://doi.org/10.1186/s12872-023-03551-x

    Powered by WPeMatico

    Type 1 diabetes during pregnancy may increase risk of most types of congenital heart defects in offsprings: JAMA

    Finland: A recent study published in JAMA Network Open has revealed type 1 diabetes (T1D) to be a risk factor associated with all subtypes of congenital heart defects (CHDs), while obesity and overweight were associated with certain CHD types, indicating distinct teratogenic mechanisms.

    The cohort study of over 620,000 children revealed that maternal T1D was associated with a 3.77-fold increase in adjusted odds for any CHD in offspring and the risk was increased in six of nine CHD subgroups. There are associations between obesity and overweight with odds of offspring CHD in a few anatomical subgroups.

    Maternal diabetes and obesity or overweight are known to be associated with increased CHD risk in offspring, but no large studies have analyzed outcomes associated with these factors in 1 model. To fill this knowledge gap, Riitta Turunen, Helsinki University Hospital and University of Helsinki, Helsinki, Finland, and colleagues aimed to investigate the association of maternal diabetes and overweight or obesity with CHDs among offspring in 1 model in a nationwide, population-based register study.

    The study was conducted in a birth cohort from Finland comprising children born from 2006-2016 (620 751 individuals) and their mothers. The researchers assessed maternal prepregnancy body mass index (BMI), categorized as underweight (<18.5), normal (18.5-24.9), overweight (25.0-29.9), and obesity (≥30). They also classified maternal diabetes status as no diabetes, type 1 diabetes, type 2 or other diabetes, and gestational diabetes, was assessed.

    Odds ratios (ORs) of isolated CHDs were found in children. In addition, nine anatomical CHD subgroups were studied.

    The study led to the following findings:

    • Of 620 751 children (51.0% males; 92.3% of mothers aged 20-40 years) born in Finland during the study period, 1.7% of children had an isolated CHD.
    • Maternal type 1 diabetes was associated with increased odds of having a child with any CHD (OR, 3.77) and 6 of 9 CHD subgroups (OR range, 3.28 for other septal defects to 7.39 for transposition of great arteries) compared with no maternal diabetes.
    • Maternal overweight was associated with left ventricular outflow tract obstruction (OR, 1.28) and ventricular septal defects (OR, 0.92), and obesity was associated with complex defects (OR, 2.70) and right outflow tract obstruction (OR, 1.31) compared with normal maternal BMI.

    The cohort study emphasizes T1D as a risk factor linked with offspring CHDs, whereas gestational diabetes and maternal obesity and overweight were associated with a smaller risk in risk, at least in this high-resource setting with universal antenatal care. The risk at the population level is substantial with an increasing prevalence of maternal overweight and GD.

    It has been shown that standard maternal diabetes treatment is linked with a lowered risk of anatomical malformations in offspring. This, primary prevention of maternal obesity and overweight and careful treatment of pregestational diabetes may hold the opportunity to lower the disease burden.

    “The prevention of these CHD subtypes may be further improved by a better understanding of the underlying mechanisms of maternal obesity and obesity in increased offspring risk for left ventricular outflow tract obstruction (LVOTO), right ventricular outflow tract obstruction (RVOTO), and other complex defects,” the researchers wrote.

    Reference:

    Turunen R, Pulakka A, Metsälä J, et al. Maternal Diabetes and Overweight and Congenital Heart Defects in Offspring. JAMA Netw Open. 2024;7(1):e2350579. doi:10.1001/jamanetworkopen.2023.50579

    Powered by WPeMatico

    Totally magnetic technique effective option for sentinel lymph node detection and breast cancer localization

    Totally magnetic technique effective option for sentinel lymph node detection and breast cancer localization suggests a new study published in the JAMA Surgery

    Guidewires have been the standard for breast lesion localization but pose operative and logistic challenges. Paramagnetic seeds have shown promising results, but to the authors’ knowledge, no randomized comparison has been performed.

    A study was done to determine whether the combination of a paramagnetic seed and superparamagnetic iron oxide (SPIO) is equivalent to guidewire and SPIO for breast cancer localization and sentinel lymph node detection (SLND).

    This was a phase 3, pragmatic, equivalence, 2-arm, open-label, randomized clinical trial conducted at 3 university and/or community hospitals in Sweden from May 2018 to May 2022. Included in the study were patients with early breast cancer planned for breast conservation and SLND. Study data were analyzed July to November 2022.

    Participants were randomly assigned 1:1 to a paramagnetic seed or a guidewire. All patients underwent SLND with SPIO.

    Results

    A total of 426 women were included in the study. The re-excision rate was 2.90%, and the median (IQR) resection ratio was 1.96 (1.15-3.44). No differences were found between the guidewire and the seed in re-excisions (6 of 211 [2.84%] vs 6 of 209 [2.87%]; difference, −0.03%; 95% CI, −3.20% to 3.20%; P = .99) or resection ratio (median, 1.93; IQR, 1.18-3.43 vs median, 2.01; IQR, 1.11-3.47; P = .70). Overall SLN detection was 98.6% (95% CI, 97.1%-99.4%) with no differences between arms (203 of 207 [98.1%] vs 204 of 206 [99.0%]; difference, −0.9%; 95% CI, −3.6% to 1.8%; P = .72). More failed localizations occurred with the guidewire (21 of 208 [10.1%] vs 4 of 215 [1.9%]; difference, 8.2%; 95% CI, 3.3%-13.2%; P < .001). Median (IQR) time to specimen excision was shorter for the seed (15 [10-22] minutes vs 18 [12-30] minutes; P = .01), as was the total operative time (69 [56-86] minutes vs 75.5 [59-101] minutes; P = .03). The experience of surgeons, radiologists, and surgical coordinators was better with the seed.

    The combination of SPIO and a paramagnetic seed performed comparably with SPIO and guidewire for breast cancer conserving surgery and resulted in more successful localizations, shorter operative times, and better experience.

    Reference

    Pantiora E, Jazrawi A, Hersi A, et al. Magnetic Seed vs Guidewire Breast Cancer Localization With Magnetic Lymph Node Detection: A Randomized Clinical Trial. JAMA Surg. Published online December 27, 2023. doi:10.1001/jamasurg.2023.6520

    Keywords:

    Totally, magnetic, technique, effective, option, for, sentinel, lymph, node, detection, and, breast, cancer, localization, Pantiora E, Jazrawi A, Hersi A, JAMA Surgery

    Powered by WPeMatico

    Heat shock protein 90 inhibition effective and safe option against Hidradenitis Suppurativa

    In a recent clinical trial discovered promising outcomes of heat shock protein 90 inhibition by RGRN-305 for individuals suffering from moderate to severe Hidradenitis Suppurativa (HS), a painful immune-mediated disorder. This results were published in Journal of American Medical Association.

    The randomized clinical study was conducted from September 22, 2021, to August 29, 2022 at the Department of Dermatology, Aarhus University Hospital in Denmark. The study included 15 patients who met eligibility criteria-aged 18 or older with moderate to severe HS and aimed to evaluate the feasibility of using RGRN-305, a heat shock protein 90 inhibitor in treating the disorder.

    The patients randomly received either oral RGRN-305, a 250-mg tablet, or a matching placebo once daily for 16 weeks. The primary efficacy endpoint was the percentage of patients achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR-50) at week 16.

    The trial demonstrated that the RGRN-305 group outperformed the placebo group in achieving HiSCR-50 at week 16, with 60% compared to 20%, respectively. Secondary endpoints included HiSCR-75 and HiSCR-90, Dermatology Life Quality Index scores, and a pain numeric rating scale, also showed significant improvements in the RGRN-305 group.

    The safety of RGRN-305 was significant in the study, with no deaths or serious adverse events reported. Treatment-emergent adverse events were equally distributed between the RGRN-305 and placebo groups which indicated that this treatment was well-tolerated.

    These highlights suggest that heat shock protein 90 inhibition by RGRN-305 presents a promising mechanism of action against Hidradenitis Suppurativa. The success of this trial underscores the importance of further evaluation in larger-scale cohorts to improve and ease the quality of life of individuals with this painful immune disorder.

    Source:

    Ben Abdallah, H., Bregnhøj, A., Emmanuel, T., Ghatnekar, G., Johansen, C., & Iversen, L. (2023). Efficacy and Safety of the Heat Shock Protein 90 Inhibitor RGRN-305 in Hidradenitis Suppurativa. In JAMA Dermatology. American Medical Association (AMA). https://doi.org/10.1001/jamadermatol.2023.4800

    Powered by WPeMatico