Stress Urinary Incontinence

This project will be launched after the first introduction of Virtue® Male Sling in Europe. This study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with Virtue® Male Sling System by urologists who are experienced in the device. The patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). Routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. Then questionnaires will be mailed annually during 2 additional years.

The goal of this prospective, multicenter, single-arm study is to assess the long-term safety and effectiveness of the FDA approved eCoin® implanted tibial nerve stimulator in a real world setting. Eligible subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI) will be implanted with the eCoin® implanted tibial stimulator and complete voiding diaries and questionnaires at follow-up visits through 5 years.

The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight. SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from screening to safety follow-up.

Prostate cancer is a highly prevalent malignant tumor among men, ranking second in male malignant tumors. Radical prostatectomy (RP) is a primary treatment option for localized prostate cancer, with laparoscopic radical prostatectomy (LRP) being the most commonly used surgical method. Currently, the evaluation of prostate surgery's effectiveness has expanded beyond merely improving patients' overall survival rates. Both doctors and patients now also prioritize the recovery of postoperative functions. Patel et al. proposed five consecutive criteria for evaluating RP outcomes:Long-term tumor control，Retention of urinary control function，Retention of erectile function，No surgical complications，Negative incisal margin.Urinary incontinence is a significant complication post-RP that severely impacts the quality of life and the willingness of patients to undergo RP. Thus, clinicians continuously improve surgical techniques to enhance urinary control post-RP. Research indicates that retaining and reconstructing urinary control-related structures can influence postoperative urinary control. Despite various techniques being employed, there is no definitive evidence on the best method for postoperative urinary control. Current techniques to improve postoperative urinary incontinence include:Intraoperative retention of membranous urethra length (MUL)，Retention of bladder neck，Retention of neurovascular bundle (NVB)，Reconstruction of bladder neck.The internal urethral sphincter, located at the bladder neck, coordinates and controls urination. A study by Nyarangi-Dix et al. showed that preserving the bladder neck opening significantly improves urinary control post-LRP, with urinary control rates of 84.2%, 89.5%, and 94.7% at 3, 6, and 12 months, respectively. These rates were higher compared to those without bladder neck preservation, at 55.3%, 74.8%, and 81.4%. The impact of NVB retention on urinary control remains controversial, but it may increase the positive resection margin rate. The external urethral sphincter also plays a crucial role in postoperative urine control.Some scholars found that maximizing the preservation of the membranous urethra during surgery improved urinary control rates at 30 days and 1 year post-surgery, reduced the use of urinary pads, and enhanced patients' quality of life.Various scholars have employed different reconstruction techniques to improve postoperative urinary control. For instance, ROCCO et al. used a posterior urethral fascia reconstruction technique, continuously suturing the severed ends of the anterior layer of Denonvilliers' fascia, the posterior bladder wall, the posterior wall of the external urethral sphincter, and the fibrous structure below the external urethral sphincter before vesical-urethral anastomosis. This technique restores the external urethral sphincter to its original anatomic position and reduces vesicourethral anastomosis tension. The anterior suspension technique, first proposed by Walsh and later applied in LRP by Patel et al., involves suturing the dorsal vein complex (DVC) to the periosteum of the pubic arch to enhance anterior urethral wall support and restore elastic suspension. The Hood technique, another commonly used method, requires freeing the fat layer on the anterior bladder wall's surface to establish the surgical space without fully exposing the retropubic Retzius space. This preserves the suspension support structures around the retropubic urethra, ensuring its integrity.In China, Liu Zhibin et al. used anterior wall reconstruction and posterior wall strengthening techniques for bladder neck and urethra reconstruction to improve postoperative urine control. These advancements in surgical techniques demonstrate the continuous effort to enhance the quality of life for prostate cancer patients undergoing radical prostatectomy by improving postoperative urinary control. Even with the numerous surgical techniques available to improve postoperative urinary control for LRP patients, postoperative urinary incontinence remains a significant issue for many. In recent years, our center has adopted a novel bladder neck and urethra reconstruction method during laparoscopic radical prostatectomy for prostate cancer. We utilize the "inverted tennis racket" technique to reconstruct the bladder neck, which lengthens the posterior bladder wall, followed by vesicourethral anastomosis. Post-anastomosis, this is positioned at the upper margin of the symphysis pubis. The anterior bladder wall is then secured behind the symphysis pubis using a continuous 3-0 barb suture. This method has yielded improved results, significantly reducing the rate of postoperative urinary incontinence. Prostate cancer patients admitted to the Department of Urology at Suzhou Hospital, affiliated with Nanjing Medical University, post-January 2025, were selected for the study. Eligible prostate cancer patients were randomly divided into four groups:1.Posterior wall reconstruction group,2.Posterior wall reconstruction + suspension group.3.Sham group.4.Anterior suspension group All four groups underwent laparoscopic radical prostatectomy via an extraperitoneal approach. During the bladder neck urethral reconstruction step, the experimental groups received the new bladder neck urethral reconstruction, while the control groups underwent conventional surgery. Patients were followed up post-surgery, comparing the urinary control status of both groups immediately after catheter removal and at 1 month, 3 months, 6 months, and 12 months post-surgery. Inclusion Criteria:1.Age \< 80 years old.2.Preoperative biopsy confirming prostate cancer.3.Clinical stages T1 and T2 Exclusion Criteria: 1.Diseases significantly increasing the risk of surgery or anesthesia (e.g., severe cardiovascular disease, respiratory disease, clotting disorders).2.Extensive bone or other organ metastases.3.History of urinary incontinence or transurethral resection of the prostate.4.Tumor invasion Surgical Procedure for the Posterior Reconstruction Group: (1)Establish the extraperitoneal space and place the Trocar.(2)Separate the Retzius space, incise the pelvic fascia on both sides of the prostate, sever the bilateral puboprostatic ligaments, and suture the dorsal vein complex (DVC) with 2-0 barb wire.(3)Treat the bladder neck: cut the anterior bladder neck wall sharply with an ultrasonic knife at the prostate-bladder neck junction (12 o'clock), revealing the posterior bladder neck wall. Separate the posterior bladder neck wall on both sides along the level between the bladder neck and prostate using an ultrasonic knife.Separate the prostate and seminal vesicles: find both vas deferens behind the bladder and cut them off, free both seminal vesicles, expose and cut off the lateral ligaments of the prostate with Hem-o-Lok. Open the Denonvilliers fascia and bluntly sharpen the prostatic gland to the apex.Cut off the prostate tip and urethra: cut the DVC with an ultrasonic knife, fully free the urethra at the prostate tip, preserving as much functional urethra length as possible. Cut the urethra with scissors, completely remove the prostate, and place it in a specimen bag without removing it from the body.Perform bladder neck reconstruction and bladder neck urethral anastomosis: reconstruct the bladder neck using the "inverted tennis racket" method to narrow the bladder neck opening and lengthen the posterior bladder wall. Measure the length of the extended part. Suture the bladder and urethra with a 2-0 sliding line from 5 o'clock, with a total of 8-10 stitches.This innovative method aims to improve postoperative urinary control and enhance the quality of life for patients undergoing laparoscopic radical prostatectomy. Posterior Reconstruction + Anterior Suspension Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture. Sham Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra. Anterior Suspension Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture. Assessment Methods for Urinary Incontinence: The primary assessment methods include the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), daily urine pad usage, and 24-hour pad weight measurement. Post radical prostatectomy, the standard for urine control is achieved by either not using any urine pads or experiencing no urine leakage daily or by using only one safety urine pad. The ICIQ-SF and the 24-hour pad test were used to objectively evaluate urinary incontinence immediately after Foley catheter removal. Assessments were repeated at 1, 3, 6, and 12 months post-surgery.

This is a non-interventional prospective study. The study will include male patients who underwent the Victo artificial sphincter placement due to severe incontinence. Before the procedure, all patients will undergo a standard diagnostic work-up. After the procedure, the patients will be invited for regular visits 3 months after device activation and subsequently every 12 months. In addition to the regular visits, patients will be allowed to contact the study center at any time if their continence worsens enough to require adjustment or if they experience any complications. The surgical technique of the Victo artificial sphincter implantation has been described in detail elsewhere. A non-parametric one-way ANOVA Friedman test will be used to compare the changes of categorical variables from baseline to the end of follow-up. Wilcoxon rank-sum test will be used to assess the change of the non-categorical variables. P-value \< 0.05 is considered statistically significant and no correction for multiple testing will be applied.

A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.

Use the provided software or tools to analyze the recorded data, including (cadence, velocity, swing, and double limb support, stride time, step length, and stride length) of gait. The software measures the cadence as total number of steps per minute, and it measures the stride time as the time (in sec) from heel strike of one limb to the next heel strike of the same limb. Also, the software measures the duration of stance, swing, and double limb support as percentage of stride time. Also, the software measures the step and stride length (in cm).

The AnovaOS™ Network Powered Patient Registry may be used to inform the development and conduct of clinical trials and observational studies designed to better understand, prevent, diagnose, treat, ameliorate or cure disease. The AnovaOS™ Network Powered Patient Registry may additionally be used to expedite identification and recruitment of participants for clinical trials of promising therapeutics and observational studies.

Worldwide there is a lot of commotion about the effects and complications of various implants. In analogy to patients with silicone breast implants, some patients report various systemic complaints following inguinal polypropylene (PP) mesh implantation, suggesting 'Autoinflammatory/Autoimmunity Syndrome Induced by Adjuvants' (ASIA; Shoenfeld's syndrome) or some other suspected systemic auto-immune/inflammatory response. Although an evidence-based and causal relationship is lacking, patients report serious complaints. Therefore, the investigators recently started seeing these patients at the outpatient clinic and developed a diagnostic workup, including an elaborate anamnesis, conventional immunologic analyses and mesh allergy testing (MAT). Further, in case the implant is removed as part of the treatment due to a persistent wish of the patient, the PP explant will be histologically examined to find additional cues for an auto-immune/inflammatory response (and thus ASIA). So far, evidence on the optimal diagnostic workup for patients with suspected ASIA syndrome is lacking completely.

Specific Aim 1: To determine if receiving prophylactic oral antibiotics at time of urethral bulking reduces the risk of post-operative urinary tract infection (UTI). Patients will be randomized and blinded into two arms: oral antibiotic versus placebo. Patients will receive either the placebo pill or oral antibiotic in the pre-operative holding area prior to their procedure. Oral antibiotics will include trimethoprim/sulfamethoxazole (Bactrim, first line) or nitrofurantoin (Macrobid, second line), determined by patient allergies. Specific Aim 2: To assess if factors such as patient discharge with ISC/indwelling foley or number of Bulkamid injection sites is correlated to improvement in Stress urinary incontinence (SUI) at 6 weeks postoperatively and at one year postoperatively. Patients will complete a brief survey preoperative, at 6 weeks postoperatively after their procedure, and at 1 year postoperatively after their procedure. The survey will consist of prior validated urogynecologic surveys including the Pelvic Floor Disability Index/Urinary Distress Inventory (PFDI/UDI- 6) and the MESA questionnaires as well as an extended VAS scale to evaluate global improvement. Specific Aim 3: To discern if any patient characteristics are associated with higher patient satisfaction following the procedure.