Premature Ejaculation
Premature ejaculation is a common male sexual dysfunction characterized by ejaculation occurring sooner than desired, often with minimal sexual stimulation.
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Found 37 Actively Recruiting clinical trials
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Autologous and Allogeneic hematopoietic stem cell transplant (HCT) are potentially curative treatments for many patients with hematologic malignancies and benign hematologic conditions. The use of HCT has increased over the last decade. HCT survivors experience a substantial and drastic deterioration in their sexual function that persists for many years post-HCT. Sexual dysfunction is the most common long-term complication in HCT survivors. Sexual health problems have negative consequences on patients' quality of life (QOL) and mood, including the individual's identity and self-esteem, fatigue, relationship discord, intimacy problems, and distress. The etiology of sexual dysfunction in HCT survivors is multi-factorial, and can stem from biological, interpersonal, psychological, and social factors. Given the multi-factorial nature underlying sexual dysfunction in this population, a multimodal approach is required to address them. Clinicians lack sufficient training to address sexual health problems in HCT survivors. HCT survivors report having little communication with their clinicians about sexual health. HCT survivors would benefit from interventions to empower them to communicate with their clinicians about their sexual health. Despite the well-documented burden of sexual dysfunction in HCT survivors, interventions tailored to address their unique sexual health concerns are lacking. Given the multi-factorial nature of sexual health concerns in HCT survivors, interventions must address these diverse needs, and should therefore ideally be addressed by a multidisciplinary team of sexual health experts, psychologists, gynecologists, and urologists. Although a few transplant centers have a multidisciplinary sexual health clinic, the lack of professionals trained in addressing sexual health concerns severely limits the dissemination of such a complex service model. In addition, HCT survivors often find it difficult to attend multiple clinic appointments and coordinate their care among various specialists. Limited availability of sexual health clinicians also hinders the scalability and dissemination of sexual health interventions to address the needs of HCT survivors. Digital health interventions can enhance access and broad dissemination of psychological and supportive care interventions and will enable patients to access the intervention in the privacy of their home given the sensitivity of the topic, engage their partners with the content, and avoid additional clinic visits. A successful evidence-based sexual health intervention was adapted to a digital app for HCT survivors. The active components of an in-person sexual health intervention for HCT survivors were leveraged to develop the self-administered digital application, Sexual Health and Intimacy Following Transplant (SHIFT) to address the sexual health concerns of HCT survivors. This multi-site randomized trial will test the efficacy SHIFT for improving sexual health outcomes, quality of life, and psychological distress in HCT survivors.
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This study focuses on women aged 18 to 70 who require surgery for benign adnexal disease (removal of an ovarian cyst, ovary and/or fallopian tube). This is a randomised study, i.e. each woman will be randomly assigned the surgical technique used for the planned operation, either vNOTES or conventional transabdominal laparoscopy. Currently, there are no randomised clinical trials specifically investigating the impact on women's sexual quality of life after benign adnexal surgery compared to conventional transabdominal laparoscopy. Patients appear to be more reticent about the vaginal approach to surgery due to fear of possible alteration of their sexual activity afterwards. Indeed, their fears relate to the vaginal scarring that occurs during the vNOTES surgery. The vaginal scar could cause vaginal pain and pain during sexual intercourse, especially if there is a post-operative complication with the vaginal scar. The vaginal scar could also alter women's perception of their bodies during sexual intercourse. This study is necessary to answer these questions and increase women's acceptance of the vNOTES technique for benign adnexal surgery. In this way, women would benefit from the advantages of vNOTES without fearing an impact on their sexual quality of life. The primary objective of this study is to demonstrate that the vNOTES technique, although using the vagina as an entry route, does not significantly alter the quality of sexual life of women after benign adnexal surgery compared to conventional transabdominal laparoscopy. The secondary objectives of this study evaluate the effectiveness of vNOTES (impact on pain, length of stay after surgery and patient satisfaction), complications ( during surgery and up to 30 days after surgery), as well as the relationship between the need to cut the surgical specimen for extraction and the difficulty of microscopic analysis. All participants in the study, regardless of the surgical technique assigned to them, will complete questionnaires to assess their quality of sexual life before surgery and at 3 and 6 months after surgery. These are the FSFI (female sexual function), CSI-16 (couple satisfaction) and a self-created questionnaire on pain during sex (dyspareunia). These questionnaires will determine whether there is a difference in the women's quality of sexual life before and after surgery, as well as comparing the two surgical techniques. The participants' general and medical data will be collected at the time of study enrolment, during hospitalisation and at one month after surgery to assess the secondary objectives of the study.
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The purpose of this study is to assess the impact of the web-based intervention OMGYES.com on sexual dysfunction in young adult (YA) female-bodied cancer survivors. This pilot trial seeks to evaluate the intervention's: * feasibility * acceptability * appropriateness. Researchers will utilize an active observation period to compare outcomes between those receiving the intervention immediately and those who haven't Participants will: * Complete online modules at home * Visit the clinic every 5 weeks for questionnaires
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Introduction Overview Remote health monitoring is becoming more commonplace in traditional and non-traditional medical practices, including for the analysis of blood. As venipuncture processes may cause distress and lead to lower patient compliance, the ability to collect blood through capillary samples is becoming increasingly popular due to patient demand and the limited availability of phlebotomists. With recent advances in lab instrumentation, the ability to analyze small volumes of blood to support the diagnostic process is gradually becoming more established. Despite the development of several novel devices to collect capillary samples, limited data is available on the stability of such samples across various environmental conditions and lengths of time. In addition, there continues to be a need to compare the correlation between lab results obtained from capillary samples, as compared to venous samples, which is the gold standard. The aim of this study is to collect capillary (fingerstick) blood samples and under various circumstances, assess their viability for broad-based consumer lab testing. Background Traditionally, clinical lab results have been limited to data collected from select sites that have phlebotomists on-site. While valuable, these diagnostic services are only available to individuals who live close enough to a lab, thereby limiting our understanding of disease within the broader community. Lab visits are limited to very specific episodes of care, which exclude the ability to remotely monitor the progression of disease. In addition, these limited lab visits usually only study a small set of assays within each individual, biasing our understanding of any other underlying medical conditions that exist within a population. The need to develop technology to make diagnostic services more accessible is paramount to not only better treat acute and chronic diseases, but to also support behavioral change toward the prevention of disease. At-home blood collection for lab testing has become increasingly popular to monitor disease and access treatments more rapidly. The ability to broaden access to diagnostic testing, especially in healthcare deserts, is valuable to mitigating the progression of disease. For example, clinicians will have access to a higher volume of lab data and be able to identify disease patterns more readily, which may lead to quicker intervention. On a population health level, improved access to diagnostics will provide insights into patient behavior and underlying disease states that may otherwise not be observed. Empowering patients to collect their own samples will provide a longitudinal view of disease, and enable deeper discussions with their clinicians regarding appropriate treatment and lifestyle changes. Study Design This is an internal observational study, non-interventional. Methods Sample Collection and Handling Specimens will either be self-collected by the subject (capillary samples) or collected by a licensed healthcare professional (capillary or venous samples) at the investigator's wholly-owned facility or a subject's home. Specimens will be stored or transported to one of the investigator's laboratories, a third-party laboratory, or a research facility for use in analytical research studies. Subjects may elect to provide a single sample, or continue providing samples on a regular basis until the subject withdraws from the study, is removed from the study, or the study is closed. Study visits are limited to 1 visit per 24 hour period. Specimen Type and Collection Methods Specimen Collection Method Capillary Blood Capillary blood will be collected from a finger using a standard lancet, by the subject independently or with the assistance of a licensed healthcare professional. Collection instructions, following consent: Either independently, or under the direction of research staff, apply a hand warmer on the desired finger or run the finger under warm water for 1 minute. Dry finger. Clean skin with an alcohol wipe, and allow the alcohol to dry. Apply lancet to finger. Drip blood into a specified collection container, which may be a capillary tube or other blood transfer device. Notwithstanding any other specimen collections described in this protocol, a maximum of 4 capillary blood draws may be collected in one visit (less than 4 mL total). At-home kit: When subjects collect their own samples off-site, all necessary containers, materials, and instructions for shipping will be included in the original collection kit. Shipment will be designed to comply with packaging associated with "Exempt human specimen." Shipment preparation procedure will be as follows: Sample is placed in a sealed primary receptacle (tube, vial, container), then secondary packaging (cushioning and absorbent materials), and then into outer packaging. Venous Blood Venous blood will be collected from the antecubital fossa, forearm, or hand of the subject by a licensed health professional: phlebotomist, physician, nurse, or physician assistant. This collection may occur on-site at the investigator's facility, the subject's home or office, or at any location that is appropriate and convenient. Collection instructions, following consent: The investigators will obtain consent from the subject and schedule the subject for phlebotomy at a specific time and site. The healthcare professional performing the specimen collection will confirm with the subject that the subject has provided consent, and confirms that the subject understands that the blood collection will be for research purposes, including for commercial product development, and not for the purpose of diagnosis or treatment. The subject's name and date of birth will be confirmed by the healthcare professional. Additional personal health and demographic information may be collected at this time or any other time during the visit. Venipuncture: The arm will be prepared with a tourniquet and disinfected with an alcohol pad. Up to 5 tubes (approximately 25 mL) of blood may be collected. After the application of sterile gauze, the needle will then be removed and pressure maintained for at least 1 minute. Following visual examination for any side effects, the venipuncture site will be dressed with a bandage on top of the gauze to apply mild pressure to the venipuncture site. Alternatively, pressure will be maintained for at least 3 minutes with gauze, followed by the application of a self-adhesive bandage. Sample Processing Blood specimens collected under this protocol will be processed to assess specific study endpoints intended to support the development and validation of laboratory assays and procedures. Variables of interest may include but are not limited to Temperature Variations: The aliquots may be subjected to different temperature ranges representative of real-life situations, such as refrigerated (2-8°C), room temperature (20-25°C), and elevated temperatures (e.g., \> 37°C). Some stability studies might also include extreme temperatures to assess how the sample performs under stress conditions. Time Points: Each aliquot may be assessed at multiple time points to evaluate the stability of the specimen over time. Common time points for stability testing could be 0 hours (baseline), 24 hours, 48 hours, 72 hours, and so on, depending on research objectives. Component Separation: Depending on the type of research being conducted, the blood specimens may undergo component separation. This process involves centrifugation to separate the different blood components - plasma, serum, and cellular elements (red and white blood cells). This separation allows the individual components to be analyzed independently, providing valuable insights into how each component behaves during research. Humidity: Assessing the impact of varying levels of humidity on blood specimen stability, especially in climates with high moisture content. Light Exposure: Investigating how exposure to different light conditions (e.g., natural light, fluorescent light) might influence the stability of certain analytes in the blood. Freeze-Thaw Cycles: Replicating scenarios where specimens experience repeated freezing and thawing to evaluate the effects on sample integrity. Anticoagulants and Additives: Exploring the impact of different anticoagulants or additives on specimen stability to optimize blood collection tubes and preservation methods. Shipping and Transportation Conditions: Studying the stability of blood specimens during transit and evaluating the impact of varying transportation conditions. Specimen Volume: Investigating whether different specimen volumes influence stability and testing accuracy. Freezer or Fridge Storage: Examining the stability of blood specimens under long-term refrigerated or freeze storage conditions (e.g., -20°C, -80°C). pH and Buffering Conditions: Assessing the role of pH and buffering systems in maintaining the stability of blood components. Hemolysis and Clot Formation: Investigating the impact of hemolysis and clot formation on test results and evaluating their effects on specimen stability. The list of variables mentioned above is not exhaustive, and additional factors may be considered based on the specific objectives of the research study. Procedure Screening / Consent Potential subjects will complete screening using an electronic form, including a brief medical history. Potential subjects will undergo informed consent. Sample Collection Subjects will attend the study visit at the clinic to have blood samples collected OR Subjects will self-collect samples at home following provided instructions and ship samples to the designated laboratory. Upon completion of sample collection, subjects will be compensated for their participation and dismissed from the study visit. Subjects may choose to remain enrolled in the study and participate in future study visits, or withdraw from study participation at any time. Potential Risks and Benefits This research falls under a minimal risk category. The probability of harm or discomfort is comparable to routine clinical examination. All specimen collection is routine with minimal risk of persistent bleeding or infection. There are no direct benefits to the subjects. Research performed based on the collected samples may lead to advances in medical research and commercial (for-profit) products with societal benefits.
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Healthy Volunteer
This is a controlled study of patients with and without primary premature ejaculation. It is based on near-infrared spectroscopy (NIRS) functional brain imaging to detect and compare changes in brain activity in resting and task states (Simulated Sex) between the two groups of patients.
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This study uses a prospective, multi-center, two-arm, single-blinded, interventional study. The subjects will be enrolled and randomly assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with both the BTL-699-2 and HPM-6000UF devices. Group A will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%) and Group B, which receives sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%). The Patient Health Questionnaire-9 (PHQ-9) will be administered to the subjects before the first treatment, at every treatment visit except the first, and at the two follow-up visits-1 month and 3 months after the final session. The 6-item Hamilton Depression Rating Scale (HAMD-6), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), 6-item Female Sexual Function Index (FSFI-6), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), and Columbia Suicide Severity Rating Scale-Screen version (CSSRS) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session. The Greene Climacteric Scale (GCS) will be administered at baseline The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject Satisfaction Questionnaire will be given after the last treatment and at both follow-up visits. The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.
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Detailed Description The considerable prevalence of sexual dysfunction (SD) after prostate cancer (PCa) treatment makes SD post-treatment a substantial health-related quality of life burden for patients and their partners. Research indicates that 40% to 75% of men suffer from SD post-PCa. Sixty percent of men experience significant distress in response to SD. Significant distress is also reported by partners and couples. Overall, patients cite sexual health concerns as the most significant unmet need following treatment for PCa. Accordingly, there is an existent need for equitable, timely, and affordable access to high-quality SD treatment for Canadian PCa patients and their partners. Unfortunately, none of the empirically-based, comprehensive interventions reported in the literature have been implemented into clinical settings in Canada. The lack of translation from research evidence to clinical implementation is common across healthcare provision. It is known that most research, even positive full-scale studies, do not result in practice-change or take years to do so. A key aspect contributing to this lack of knowledge translation is the complexity of transitioning an "experimental intervention" to "real world" clinical settings. In sexual healthcare in oncology, ineffective knowledge translation is ubiquitous and includes several unique complexities that impair the implementation, integration, and sustainability of empirically-based treatment. The recent advent of virtual care in healthcare offers an opportunity to address many of the barriers to implementing sexual recovery programs within PCa treatment facilities. Virtual care provides greater accessibility for patients not proximal to cancer centres, or who are unable to travel due to financial constraints or physical limitations. Encouragingly, examples of internet-delivered interventions exist for men with PCa and their partners. Schover and colleagues found that a digitally-based intimacy enhancement intervention was as effective as a brief in-person sex therapy intervention in improving sexual outcomes in couples after PCa. Although these advances in models of care provision are inspiring, the majority of Canadian PCa patients and their partners have yet to benefit from virtual care innovations. In an effort to advance evidence-based survivorship programming in the treatment of SD post-PC, a team of expert Canadian healthcare practitioners and patient/partner advocates developed the Sexual Health and Rehabilitation eClinic (SHAReClinic). SHAReClinic is a web-based, bio-psychosocial SD intervention specifically for patients/couples who have undergone treatment for PCa. A pilot study evaluating the acceptability and engagement of SHAReClinic achieved significant patient activity on the platform and 80% patient engagement at 1-year follow-up. Additionally, evaluation of the effectiveness of SHAReClinic showed non-inferior sexual health outcomes when compared to a "best practice" in-person sexual health clinic. Rationale Sexual dysfunction after PCa treatment has significant adverse impacts on patient/partner health-related quality of life. Few Cancer Centres in Canada offer comprehensive care for SD post-PCa treatment, resulting in significant barriers to care equity and access. SHAReClinic is established as effective virtual care programming for SD post-PCa. The goal of this research is to evaluate the SHAReClinic in 2 cancer centres currently using it as usual care and 9 cancer centres which has newly implemented SHAReClinic as part of their usual care. The SHAReClinic will be offered to 1. Newly diagnosed patients at who are scheduled to undergo active treatment for localized prostate cancer, 2. patients currently undergoing active treatment for prostate cancer and 3. patients who have undergone prostate cancer treatment within the last 6 months. Active treatment can include any of the following options surgical, radiation, and/or ADT. The SHAReClinic goals are to re-establish optimal sexual function, satisfaction and to support the maintenance of intimacy following prostate cancer treatment. These goals are addressed through two complementary components: 1) a bio-medical component (erectile rehabilitation), focused on the long term penile health or short-term erectile function as per patient preference, and 2) a psychological component (intimacy maintenance), involving the maintenance or restoration of couples' intimacy and sexual activity (penetrative or non-penetrative). Both physical and psychological factors can affect patients' sexual satisfaction after cancer treatment; resultantly, interventions should incorporate a bio-psychosocial approach to rehabilitation. Study Design This is a prospective observational evaluation of a virtual sexual health and rehabilitation intervention program. As part of patient standard care, facilitated web-based clinic visits will be provided to patients once before treatment, 6 weeks, 10 weeks, 4 months, 6 months and 12 months post cancer treatment. Patients who opt-in to the SHAReClinic will also be invited to register for this study. The study involves no additional requirements from patients, as all questionnaires (baseline, 6-weeks, 6 months, and 12 months) are completed as part of their enrolment in the SHAReClinic. Patients experience in the SHAReClinic involves the following: Upon registration, patients will be paired with a sexual health coach from their center and asked about their availability to receive a phone/video call from their sexual health coach. At the beginning of the first clinic visit, participants will be asked to complete a set of questionnaires. The questionnaires take around 10-15 minutes to complete. Patients are also asked to complete the same questionnaires at 6 week, 6 months and 12 months. The topics covered in each clinic visit vary and are based on the treatment schedules of the participants. A Q\&A session on the web page will be available for participants to leave any questions or concerns regarding their sexual health, rehabilitation process and the content of the portal. Participants are free to request for a check-in call with their sexual health coach if they want to chat about their concerns by phone. Each clinic visit will last approximately 30 minutes. If participants miss their clinic visit, they will get a notification from the platform and then a reminder call from their sexual health coach. At the end of their final SHAReClinic clinic visit, participants will be asked to fill out a satisfaction questionnaire, including questions about the ease of access to the website, their experience with SHAReClinic portals and communication with their sexual health coach. The satisfaction questionnaire takes about 10 minutes to complete.
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This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum. The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS). Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis. Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records. The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women. PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.
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Health professionals, within the field of cancer, attitude towards addressing sexual health with patients is unknown. The aim is to investigate the attitudes of Danish cancer nurses towards addressing sexual health in their clinical work, as well as to assess differences in perceived competences and knowledge. Method: The questionnaire Health professionals Attitudes towards Sexual Health-Danish version (PA-SH-D) is sent out to Danish cancer nurses via the Professional Society for Cancer Nurses. The questionnaire is sent out via a link via the RedCap database. The questionnaire link is sent out to members of the Professional Association for Cancer Nurses under the Danish Nursing Council, and it is sent out via their membership register.
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Background: Premature ejaculation (PE) is a common sexual dysfunction that can significantly impact the quality of life and psychological well-being of affected individuals. Anxiety disorders, often comorbid with PE, exacerbate symptoms and complicate treatment outcomes. There is a critical need for a reliable prediction model to identify patients at risk of developing anxiety disorders associated with PE. Objective: The primary aim of this study is to develop and validate a predictive model that accurately identifies premature ejaculation patients who are at high risk of developing anxiety disorders. The model will be designed to facilitate early intervention strategies and improve patient outcomes. Methods: This prospective observational study will enroll male patients diagnosed with PE from multiple clinical centers. Participants will undergo comprehensive assessments including validated questionnaires, clinical interviews, and medical history reviews to collect baseline data on potential predictors of anxiety disorders. Machine learning algorithms will be utilized to analyze the collected data and derive a predictive model. External validation will be conducted using a separate cohort of patients not involved in the initial model development phase. Outcome Measures: The primary outcome measure will be the accuracy of the predictive model in identifying patients who subsequently develop anxiety disorders within a predefined follow-up period. Secondary outcomes include evaluating the model's sensitivity, specificity, positive predictive value, and negative predictive value. Significance: Successful development and validation of this prediction model could lead to improved patient care through targeted interventions and personalized treatment plans for those at risk of anxiety disorders related to PE. This research may also contribute to a better understanding of the complex interplay between sexual dysfunction and mental health.
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