Nocturia

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.

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.

Lower urinary symptoms (LUTS) commonly affect older men and tend to increase in frequency and severity with age, particularly due to bladder outlet obstruction from benign prostatic enlargement (BPE), also known as benign prostatic hyperplasia (BPH). This trial evaluates the safety and effectiveness of the third generation AQUABEAM Robotic System and Apogee 2300 Ultrasound System for treating LUTS caused by BPH. The study aims to compare the percentage of patients discharged on the day of surgery among different groups undergoing aquablation with this system. The intervention involves a minimally invasive surgical procedure using the AQUABEAM device, which uses an ultrasound-guided water jet to precisely remove prostate tissue through a transurethral approach. The system integrates cystoscopic visualization, ultrasound imaging, and advanced planning software to tailor the treatment to each patient's anatomy. Patients will receive aquablation therapy under general or spinal anesthesia, followed by catheter placement and monitored bladder irrigation. The procedure aims to minimize bleeding and allow same-day discharge when possible. Participants will undergo baseline assessments including urinary flow measurements, symptom scoring with the International Prostate Symptom Score (IPSS), and prostate size measurement via transrectal ultrasound. Follow-up visits will occur three months after the procedure to evaluate symptom improvement, urinary function, and safety outcomes such as adverse events. The study will monitor changes in IPSS scores and the rate of serious adverse effects immediately after surgery. Total participation is approximately three months post-treatment, with data collected to assess the therapy's impact on urinary symptoms and quality of life.

Researchers are evaluating the new Axonics External Trial System (ETS-02) in adults with overactive bladder (OAB) and/or 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 implantable neurostimulator (INS) approved for treating these conditions. Participants will use the Axonics External Trial System, which involves placing a temporary electrode wire through the S3 foramen, connected to an external pulse generator worn for a trial period of 3 to 7 days. This external system is evaluated to see if patients with OAB or FI respond to sacral neuromodulation before deciding on permanent implantation. During the study, participants are monitored for overall feasibility between days 5 and 7, and safety is assessed by recording any adverse events from day 0 to 7. The study involves keeping diaries and attending study visits to track bladder and bowel function. The total participation time includes the trial period with the external device and safety monitoring.

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.

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 and/or 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.

Overactive bladder (OAB) is a common condition affecting both men and women, causing symptoms like frequent urination, urgency, and urge incontinence that can lower quality of life. This clinical trial is evaluating whether the BTL Emsella Chair, a device using electromagnetic technology, is effective compared to a sham treatment for managing OAB symptoms. The study addresses the need for non-drug options due to side effects and poor adherence to medications, exploring a noninvasive therapy that stimulates pelvic floor muscles. Participants will receive either active treatment with the Emsella Chair or a sham treatment. The active treatment involves sitting on the chair twice a week for four weeks, where electromagnetic stimulation is gradually increased to the highest comfortable level to induce pelvic floor muscle contractions equivalent to thousands of Kegel exercises. The sham group will receive a similar setup but with minimal stimulation below a therapeutic threshold. Treatment sessions last about 28 minutes, aiming to rehabilitate weak pelvic floor muscles. During the study, participants will be assessed at baseline and followed through 8 to 12 weeks to measure improvements in bladder symptoms, urinary urgency, frequency, leakage, and quality of life using questionnaires and voiding diaries. Researchers will track responses using the Global Response Assessment and other validated tools to compare active versus sham effects. Safety and tolerability will also be monitored, with no new OAB treatments started during the study. The full participation lasts about 12 weeks from treatment start to final follow-up.

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.

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.

This observational study focuses on subjects referred for urodynamic testing to define normal pressure ranges using the e-Sense4 catheters. Researchers aim to establish typical pressure values in different body positions and during bladder filling to help interpret urodynamic tests. The study is sponsored by Laborie Medical Technologies Inc. and involves adults medically indicated for urodynamic procedures, including those with lower urinary tract symptoms. Participants will undergo urodynamic testing using the e-Sense4 catheters alongside traditional water-filled catheters. Initial resting pressures will be measured in lying, sitting, and standing positions. During bladder filling, various pressure values will be recorded at regular intervals to compare detrusor and urethral pressures between the two catheter types. This single-arm study uses the e-Sense4 device in all participants to collect data for both primary and secondary objectives. Throughout the procedure, urodynamic pressures will be assessed and recorded using the study devices. The results will be provided to the sponsor for test interpretation and publication. Researchers will monitor and compare pressure values simultaneously measured by the e-Sense4 and water-filled catheters during the test. The study participation involves a one-time urodynamic test with no placebo or control group, and the primary outcome is to determine normal pressure ranges by position during the procedure.