Nocturia is a condition characterized by waking during the night to urinate, influencing sleep quality and overall well-being. Clinical trials for nocturia often explore treatment evaluations to reduce nighttime urinary frequency and improve sleep pa...
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Found 56 Actively Recruiting clinical trials
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Researchers are investigating why some men with Benign Prostatic Hyperplasia BPH, a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.
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Nocturia, a common and troubling condition among older adults in Taiwan, often disrupts sleep quality and affects mental health while increasing the risk of falls. This research evaluates a new community-based approach that combines digital health technology and behavioral therapy to manage nocturia in people aged 55 and older who experience two or more nighttime voids. The goal is to reduce nocturnal voiding frequency, improve quality of life, and explore reducing medication reliance. Participants are divided into two groups. The intervention group uses a non-contact home uroflowmetry device and a voiding diary to track urinary patterns, receiving real-time feedback. They also get personalized lifestyle advice such as fluid restriction and leg elevation, alongside psychiatric screening for sleep and mood disorders. The control group receives general health education and follow-up without these devices or personalized interventions. Throughout the study, participants record their voiding habits for 2-3 consecutive days monthly over six months. Researchers assess nocturnal void frequency, sleep quality, mental health, anxiety, quality of life, and fall or emergency events at the start, three months, and six months after randomization. This comprehensive monitoring helps evaluate the effectiveness of the community-based management model integrating digital tools and behavioral support.
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Healthy Volunteer
This research evaluates the PureWick Urine Collection System as a non-invasive way to manage nocturia in women aged 50 and older. Nocturia, which involves waking at night to urinate, is common in older adults and increases the risk of falls and fractures. The study aims to assess whether using PureWick can reduce nighttime bathroom trips and improve sleep quality and overall life quality. Participants use the PureWick System, which includes an external catheter, tubing, and a collection canister. The device allows urine collection while remaining in bed, potentially lowering fall risk. The study is a single-group pilot conducted at one center, with follow-up lasting up to 3 months to observe urinary and sleep outcomes, as well as any related adverse events. During the study, participants are monitored for changes in the number of nocturia episodes, sleep quality via questionnaires, and other health factors such as urinary tract infections and skin condition. Data is collected at the start and after 3 months of device use. Researchers will measure how many patients achieve a 50% or greater reduction in nighttime urination, along with quality-of-life improvements and safety outcomes.
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Researchers are evaluating the effectiveness of a prescription digital therapeutic app called RiSolve compared to standard behavioral education through informational handouts for women with overactive bladder OAB. This trial focuses on women diagnosed with OAB, including symptoms like urinary urgency, urge urinary incontinence, urinary frequency, nocturia, and mixed incontinence with predominant OAB symptoms. The study aims to assess improvements in symptoms, quality of life, bladder function, patient satisfaction, and ongoing treatment effects. Participants are randomly assigned to one of two groups one group receives access to the RiSolve app for 10 weeks following activation, which offers behavioral therapy and cognitive behavioral therapy for OAB the other group receives standard behavioral education via patient handouts from the American Urogynecologic Society. After the initial 8 weeks, those in the control group may choose to switch to the RiSolve app treatment. The trial includes follow-up assessments at 6 and 12 months to monitor ongoing symptoms. During the study, participants will complete questionnaires such as the Overactive Bladder Questionnaire short-form OAB-q SF to measure symptom severity and quality of life, bladder diaries, and other validated tools to assess urinary symptoms and treatment satisfaction. Researchers will also track treatment adherence, accessibility, adverse events, and use of other therapies. The primary outcome is measured after 8 weeks, with continued symptom evaluation throughout the 12-month follow-up period to gather comprehensive data on treatment effects and patient experience.
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Researchers are evaluating the new Axonics External Trial System ETS-02 in adults with overactive bladder OAB andor fecal incontinence FI. The study aims to assess the feasibility and safety of this external trial system, which helps determine if patients respond to sacral neuromodulation SNM before receiving the Axonics implantable neurostimulator approved for treating these conditions. The Axonics External Trial System involves placing a temporary electrode wire through the S3 foramen, possibly with fluoroscopic guidance, connected to an external pulse generator worn for 3 to 7 days. This trial system is used to evaluate patient responsiveness to SNM prior to implanting the permanent neurostimulator device. Participants provide consent and undergo trial procedures including the placement and use of the external trial system for up to 7 days. Researchers monitor feasibility and safety by assessing outcomes such as overall feasibility between days 5 and 7 and adverse events from day 0 to 7. The total study period extends until December 2026, with ongoing safety monitoring during the trial period.
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Benign prostatic hyperplasia BPH is a common condition affecting many men as they age, often leading to lower urinary tract symptoms LUTS. Due to a growing and aging population, the number of men diagnosed with BPH continues to rise, making treatment for this condition one of the most performed surgical procedures in urology. This research aims to establish a global, ongoing registry that collects detailed demographic and clinical data on men undergoing medical or surgical treatments for BPH to better understand treatment patterns and outcomes worldwide. The registry records information from men aged 18 and older with a primary diagnosis of BPH and LUTS who are receiving either medication or surgical intervention. Data collected includes baseline demographics, peri-operative details, and follow-up outcomes with no actual interventions performed by the registry team. The study uses validated patient-reported outcome measures like the International Prostate Symptom Score IPSS, Sexual Health Inventory for Men SHIM, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction MSHQ-EjD, along with clinical data such as quality of life, urine flow rates, prostate-specific antigen levels, and complications related to treatment. Participants provide data over a period of three years with ongoing follow-up and no fixed end date, allowing for long-term observation of treatment effectiveness and safety. The registry also ensures data security and quality through encryption, user access controls, and regular audits. Researchers will analyze outcomes including symptom scores, quality of life, post-void residual urine, and complications like incontinence, bleeding, urinary tract infections, and erectile dysfunction, aiming to inform future BPH management and research.
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Healthy Volunteer
This research aims to explore brain activity in children with Overactive Bladder OAB and Daytime Urinary Incontinence DUI compared to healthy children of similar age and gender. It also investigates whether sacral transcutaneous electric nerve stimulation TENS influences brain areas controlling the bladder. The study focuses on children aged 6 to 14 years, as brain activity related to bladder control has not yet been studied in this group, though adult studies suggest increased brain activity may be a factor in OAB and DUI. Participants include children with OAB and DUI who will receive sacral TENS treatment applied for two hours daily over 10 weeks. The study involves two main parts a cross-sectional comparison between affected and healthy children and an interventional cohort study where children with symptoms undergo sacral TENS. Imaging sessions include structural MRI and functional MRI scans with both full and empty bladder states, performed before and after the treatment. Healthy children will have only baseline imaging. During the study, children andor their parents complete various assessments including frequency and volume charts, screening tools for attention deficit hyperactivity disorder and autism spectrum disorders, and quality of life questionnaires. Researchers will measure brain activity changes, structural brain differences, and quality of life changes before and after treatment. The primary outcomes focus on brain activity at baseline and after TENS, with secondary outcomes assessing quality of life and urinary symptoms. The study is conducted under careful monitoring to ensure safety and data quality.
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Overactive bladder OAB is a common condition affecting both men and women, characterized by symptoms like urinary frequency, urgency, and incontinence. This trial evaluates the BTL Emsella Chair, a device using high-intensity focused electromagnetic HIFEM technology, compared to a sham treatment, to see if it effectively treats OAB. The study is a randomized, double-blind trial aiming to provide a noninvasive alternative due to the challenges and side effects of current pharmacologic treatments. Participants will receive either the active Emsella Chair treatment or a sham treatment twice a week for four weeks. The active treatment involves sitting on the chair while electromagnetic stimulation induces deep pelvic floor muscle contractions, aiming to simulate thousands of Kegel exercises. The sham group will experience similar positioning but with limited stimulation below therapeutic levels. Treatment intensity is adjusted based on individual tolerance and increased over time. Throughout the study, participants will be assessed for improvement in bladder symptoms using questionnaires such as the Global Response Assessment and the Overactive Bladder Questionnaire. They will keep a voiding diary to record urinary urgency, frequency, and leakage episodes. Safety and tolerability will also be monitored. The main outcomes are measured four weeks after treatment completion, with follow-up extending to 12 weeks to assess durability of response. Total participation lasts about eight to twelve weeks.
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Researchers are evaluating two minimally invasive treatments, transurethral microwave thermotherapy TUMT and prostatic artery embolisation PAE, for men with severe lower urinary tract symptoms LUTS caused by benign prostatic hyperplasia BPH. This randomized clinical trial aims to compare the effectiveness of these treatments in reducing urinary symptoms, measured by the International Prostate Symptom Score IPSS six months after the procedures. The study also focuses on patient satisfaction, quality of life, and functional outcomes over the long term. Participants will be assigned to receive either TUMT, which uses microwave energy to destroy prostate tissue through the urethra under local anesthesia, or PAE, which involves blocking blood flow to the prostate via catheter-guided embolisation, also under local anesthesia. Both procedures are usually outpatient with same-day discharge unless hospital admission is required. Catheters are used post-procedure and are typically removed within four weeks based on individual recovery and physician assessment. During the study, participants will undergo regular assessments including symptom questionnaires, uroflowmetry tests, prostate volume measurements, blood tests, and monitoring for side effects or complications. Outcomes will be measured at multiple time points 1, 3, 6, 12, 24, and 60 months after treatment. Researchers will evaluate urinary symptoms, quality of life, sexual function, catheter use, and the need for re-treatment. The study plans to include 220 men aged 40 years or older and will monitor safety and efficacy through these detailed follow-ups.
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This research aims to collect data on the effectiveness and safety of various treatments for benign prostatic enlargement BPE and the lower urinary tract symptoms related to benign prostatic hyperplasia BPH-LUTS. The study includes men who receive treatment for these conditions at the participating institution and provides insights into different treatment options including newer methods compared to established surgical procedures. Participants receive one of several treatment options such as prostatic artery embolization PAE, transurethral resection of the prostate TURP, or other surgical procedures like holmium laser enucleation, open prostatectomy, and thulium laser vaporization. The study collects clinical, patient-reported, and imaging data prospectively as part of routine clinical care, enabling comparison of safety and efficacy among these treatment approaches. During the study, researchers will monitor participants over time, assessing changes in urinary symptoms, urinary flow rates, and residual urine volume from baseline up to one year and beyond. Assessments also include follow-up for adverse events, prostate size changes, erectile and ejaculatory function, and other outcomes over a period of up to five years. Participants contribute data through routine clinical visits, imaging, and questionnaires, helping to evaluate long-term treatment results and safety.
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