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 device's 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.

Researchers are studying how well and safely orforglipron works in adult women with stress urinary incontinence (SUI) who are overweight or have obesity. SUI causes urine leakage during activities like coughing or exercising. This research is a phase 3 trial sponsored by Eli Lilly and Company and will last about 58 weeks from screening to safety follow-up. Participants will be randomly assigned to take orforglipron tablets or a placebo orally once daily. The trial includes two independent studies under one protocol, each comparing orforglipron with placebo. The goal is to see how orforglipron affects urinary incontinence and related health measures over one year. During the study, participants will have regular assessments to track changes in incontinence episode frequency, body weight, quality of life related to urinary incontinence, use of continence pads, patient impressions of their condition, cholesterol levels, and waist circumference. Safety will also be monitored throughout the 58-week participation period.

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.

Researchers are evaluating the Adjustable Continence Therapy (ACT) device for women with stress urinary incontinence caused by intrinsic sphincter deficiency. This prospective, single arm, non-randomized, multicenter trial aims to assess the safety and effectiveness of ACT in providing meaningful improvement in symptoms for affected women. The study is sponsored by Uromedica and focuses on clinical outcomes related to urinary incontinence. The trial involves implanting two ACT devices in each participant in the paraurethral space near the bladder neck using local, spinal, or general anesthesia. The device includes balloons that are filled with an isotonic solution after implantation via subcutaneous ports placed in the labia majora. This device implantation is the main intervention studied, and participants receive follow-up care to monitor results. Participants will undergo evaluations including provocative pad weight measurement at 12 months to assess urine leakage. Additional assessments include quality of life and urogenital distress questionnaires at 12 months. Researchers will also monitor participants for safety and treatment adherence throughout the study. The trial seeks to gather comprehensive data on symptom improvement and quality of life over the course of a year following device implantation.

Researchers are studying gait characteristics in women aged 40 to 60 with and without stress urinary incontinence to better understand how this condition affects walking patterns. This observational study aims to add to current knowledge about stress urinary incontinence and its impact on mobility, which may help develop targeted treatments and rehabilitation methods to improve quality of life. The research is sponsored by Cairo University and focuses on women who have mild stress urinary incontinence and are multiparas without other gynecological issues. The study compares two groups: one group of 62 women with chronic stress urinary incontinence and another group of 62 women without urinary incontinence symptoms or pelvic floor dysfunction. Gait data are collected and analyzed using software that measures cadence, stride time, step length, stride length, and percentages of stance, swing, and double limb support. Additional assessments include force platform analysis and a three-dimensional motion analysis system to capture detailed spatiotemporal gait parameters. Participants will complete the Incontinence Symptom Severity Index to assess urinary symptoms. Gait is evaluated using a force platform and a specialized motion analysis system with cameras and markers to track movements. These measurements are taken during a single day of assessment. The primary outcome is the severity of incontinence symptoms, and secondary outcomes include detailed force and motion data. The study excludes women with pregnancy, neurological or musculoskeletal disorders, cognitive impairment, prior relevant surgery, significant medical conditions affecting gait, or walking pain.

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.