Stress Urinary Incontinence

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This observational study aims to collect medical data on the devices effectiveness and safety over 12 and 36 months after implantation. The study is conducted in multiple centers across Europe and focuses on real-world use by experienced urologists. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and help manage urinary incontinence caused by intrinsic sphincter deficiency. This study involves men who have already received the sling during routine clinical care. Follow-up includes visits at baseline before implantation, between 1 and 3 months post-operation, and at 12 months, with additional annual questionnaires sent out at 24 and 36 months. Participants will undergo routine clinical assessments, including questionnaires about their urinary symptoms and quality of life, pad weight testing, uroflowmetry, and measurement of urine remaining after voiding at several points during the study. Researchers will monitor patient-reported improvement and any adverse events at 12 months. The study extends to 36 months with ongoing questionnaires to track long-term outcomes and satisfaction. Participation involves regular clinical visits and mailed surveys over three years.

This research aims to assess the long-term safety and effectiveness of the FDA-approved eCoin4 implanted tibial nerve stimulator in people with overactive bladder OAB who experience urgency urinary incontinence UUI. The study is prospective, involves multiple centers, and follows a single group of participants to understand how the device performs in real-world use. Participants will receive an implant of the eCoin device, which provides subcutaneous stimulation to the tibial nerve. This stimulation is intended to help manage urgency urinary incontinence. The treatment involves implanting the device and then monitoring participants over time to evaluate its safety and effectiveness. Throughout the study, participants will complete voiding diaries and quality of life questionnaires during follow-up visits that extend up to 5 years. Researchers will monitor safety by tracking any device- or procedure-related adverse events and measure effectiveness by assessing responder rates at 12 and 24 months. The study includes ongoing evaluations of safety data even after reimplantation when applicable, ensuring comprehensive long-term monitoring.

This research aims to evaluate how well and safely orforglipron works in adult female participants with stress urinary incontinence SUI who also have obesity or are overweight. SUI is a condition where urine leaks during activities such as coughing or exercising. The study is a Phase 3 clinical trial conducted under a master protocol supporting two independent studies, focusing on this specific population. Participants will be randomly assigned to receive either orforglipron or a placebo, both given orally once daily. The study uses a double-blind design with parallel groups to compare the effects of orforglipron against placebo. The treatment period lasts approximately 52 weeks, followed by safety follow-up, making total participation about 58 weeks from screening to study completion. During the study, participants will undergo assessments including measuring changes in the frequency of incontinence episodes, body weight, quality of life related to urinary incontinence, use of continence pads, and cholesterol levels. Researchers will monitor waist circumference and patient impressions of their condition as well. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Prostate cancer is a common malignant tumor in men, with laparoscopic radical prostatectomy LRP being a primary treatment for early stages. Postoperative urinary incontinence remains a major complication affecting quality of life. This trial evaluates a new bladder neck and urethral reconstruction technique during LRP to improve early urinary control, comparing it with conventional methods through a randomized controlled design involving four patient groups. The study includes four groups receiving different surgical procedures posterior wall reconstruction using an inverted tennis racket method, posterior reconstruction combined with anterior suspension, a sham surgery group, and an anterior suspension group alone. All groups undergo LRP via an extraperitoneal approach. The new technique involves reconstructing the bladder neck to narrow its opening and lengthen the posterior bladder wall, with some groups also receiving suturing of the anterior bladder wall to support the urethra. Participants are followed after surgery to assess urinary control immediately after catheter removal and at 1, 3, 6, and 12 months post-operation. Assessments use the International Consultation on Incontinence Questionnaire-Short Form, daily urine pad usage, and 24-hour pad weight. The primary outcome is the rate of continence at these time points. Safety and quality of life effects are also monitored throughout the study, which lasts at least one year post-surgery.

Researchers are studying the use of the Victo adjustable artificial sphincter to treat male patients who have urinary incontinence following prostate surgery. This prospective academic study aims to evaluate how well the device works and its safety in managing severe incontinence in this group. This non-interventional study includes adult males who have already undergone implantation of the Victo artificial sphincter. Before surgery, patients receive standard diagnostic tests. After activation of the device, they will have follow-up visits at 3 months and then annually. Patients can also contact the study center at any time if their symptoms worsen or if they face any complications. During the study, participants will complete tests such as the 24-hour pad-weight test to measure incontinence severity and patient questionnaires about their improvement. Researchers will follow patients for up to 5 years to assess treatment outcomes and safety. The total participation time varies based on follow-up but involves regular monitoring and the opportunity to report issues anytime.

This research aims to evaluate the safety and effectiveness of Adjustable Continence Therapy ACT in treating female stress urinary incontinence caused by intrinsic sphincter deficiency. The trial is a prospective, single-arm, non-randomized, multicenter case-series study designed to demonstrate clinically relevant improvement in this condition. Participants will receive implantation of two ACT devices placed near the urethra and bladder neck, with ports under the skin of the labia majora. The balloons are filled with an isotonic solution after implantation using needle injection. The device can be implanted under local, spinal, or general anesthesia with specialized surgical instruments. This is the only intervention during the trial. Throughout the study, participants will be monitored for changes in provocative pad weight over 12 months as the primary outcome. Secondary assessments include quality of life and urogenital distress questionnaires. Participants must comply with follow-up visits and assessments to evaluate treatment effects and safety. The total study duration extends up to 12 months after device implantation.

Low Anterior Resection Syndrome LARS is a frequent complication after sphincter-preserving rectal cancer surgery that can worsen bowel function and quality of life. Researchers are evaluating the effects of an aerobic exercise program combined with guided imagery on bowel symptoms, quality of life, physical activity, functional capacity, and psychological well-being in patients with LARS after rectal cancer surgery. This randomized controlled multicenter trial aims to provide evidence for rehabilitation strategies to improve outcomes for these patients. Participants will be randomly assigned to one of two groups one will receive a structured aerobic exercise program along with guided imagery in addition to standard postoperative care, while the other will receive only standard postoperative care. The exercise includes structured walking at the clinic and outside for at least three days per week, and guided imagery will be practiced for at least three days during the intervention period. During the study, participants will be assessed at the start and after eight weeks using validated clinical and patient-reported measures including the Low Anterior Resection Syndrome scoring system, quality of life questionnaires, and a 6-minute walking test. Additional evaluations include distress inventories, physical activity questionnaires, anxiety and depression scales, and pelvic floor muscle function. The study will monitor changes in bowel symptoms, quality of life, and physical and psychological health throughout the intervention period.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Researchers are evaluating the use of preventive oral antibiotics at the time of urethral bulking with Bulkamid to lower the chance of urinary tract infections UTIs right after surgery in women with stress urinary incontinence or mixed urinary incontinence stress predominant. The study aims to see if antibiotics reduce post-operative UTIs and also to understand how factors like catheter use after surgery and the number of injection sites affect incontinence improvement and patient satisfaction at 6 weeks and 1 year after the procedure. Participants will be randomly assigned to receive either a single dose of oral antibiotics Bactrim or Macrobid, chosen based on allergies or a placebo pill just before their urethral bulking procedure. The study is blinded, so neither patients nor doctors will know which treatment is given. Surveys including validated urogynecologic questionnaires will be completed before surgery, and then at 6 weeks and 1 year afterward to assess urinary symptoms, improvement, and satisfaction. During the study, participants will be monitored for urinary tract infections up to 6 weeks after the procedure, and side effects and satisfaction will be assessed up to 1 year. Researchers will collect information from questionnaires and clinical evaluations to measure treatment effects and patient outcomes. The trial is led by Ohio State University and plans to follow participants for outcomes related to infection risk and urinary function after urethral bulking with Bulkamid.

Researchers are evaluating the clinical effectiveness of pelvic floor muscle training PFMT in women with stress urinary incontinence. The study compares two conservative therapy methods home exercise training using a medical vaginal device called Aniball INCO versus standard pelvic floor muscle training exercises without the device. This research aims to improve treatment options for women experiencing this condition. Participants are randomly assigned to one of two groups. The first group performs pelvic floor muscle training using the Aniball INCO vaginal device following education by a urogynecologist. The second group receives pelvic floor muscle training without the device, guided by a certified physiotherapist trained in pelvic floor disorders. Both groups follow their respective training programs over several months. During the study, participants complete questionnaires like the International Consultation on Incontinence Questionnaire ICIQ-SF at the start, after 8 weeks, and after 4 months. Objective urodynamic tests and measurements of urine leakage are conducted at baseline and after 4 months. Researchers monitor clinical severity changes and the effectiveness of the treatments, with the total participation lasting around 4 months. Safety and adherence are also observed throughout the study.