North Wales

Researchers are evaluating the long-term outcomes in women who have undergone surgery for vaginal or uterine prolapse using the GYNEMESH PS Mesh. This observational, post-market study involves both retrospective and prospective data from multiple centers to understand the effects and results of this mesh used in surgery. The purpose is to monitor patient outcomes following these surgical procedures. Participants in this study previously received laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted surgery, where the GYNEMESH PS Mesh was used as a bridging material. There is no additional intervention beyond the routine clinical care these women have already received. This study follows patients for up to approximately seven years from surgery to assess the long-term impact. During the study, participants will undergo physical examinations including Pelvic Organ Prolapse Quantification POP-Q to measure anatomical changes after surgery. They will also complete questionnaires such as Patient Global Impression of Improvement or Change, Pelvic Floor Distress Inventory, and Pelvic Organ ProlapseUrinary Incontinence Sexual Questionnaires to assess symptoms and quality of life. These assessments will be conducted from post-surgery through study completion to monitor safety and effectiveness over time.

Researchers are evaluating a skin patch test method to identify food allergies in people with Irritable Bowel Syndrome IBS. The study aims to understand if avoiding foods that cause allergic reactions can help reduce IBS symptoms. This is a randomized, double-blind study conducted by IBS-80, LLC, where neither participants nor doctors know which diet is assigned during the treatment period. Participants undergo skin patch testing for 80 different foods and additives across three office visits within 4 to 5 days. After identifying food allergies, participants are randomly assigned to follow one of two 16-week avoidance diets either avoiding foods they are allergic to true avoidance diet or avoiding foods without allergies sham avoidance diet. After completing the diet, participants complete an online questionnaire about their IBS symptoms. During the study, participants have three visits for skin patch application, removal, and reading. The study monitors IBS symptoms through a questionnaire completed after the diet period. Those on the sham diet are later informed of their true food allergies and may choose to avoid those foods. The total participation lasts about 18 weeks, including the testing and diet periods. Results will be analyzed once all 250 participants complete the study.

Researchers are evaluating the performance of the Gynecare TVT ABBREVO4 Continence System in women undergoing mid-urethral sling surgery to treat Stress Urinary Incontinence SUI. This observational, post-market clinical study focuses on long-term follow-up to assess the systems impact on continence over approximately 5 to 10 years after surgery. Participants undergo surgical treatment for SUI using the Gynecare TVT ABBREVO4 device as part of standard care. There is no additional intervention in the study beyond the usual surgical procedure and clinical care. The study follows participants from the time of surgery through long-term follow-up lasting about 10 years. During the study, participants will be monitored with assessments including the Cough Stress Test CST to evaluate continence status, patient-reported improvement measures, urinary incontinence questionnaires, sexual function questionnaires, and pain rating scales. Follow-up involves regular evaluations through the study completion date to track outcomes and safety over the long term.

This research aims to evaluate the long-term safety and effectiveness of the Neuspera Sacral Neuromodulation SNM System in people with urinary urgency incontinence who have previously participated in earlier phases of the Neuspera SANSUUI study. The system has received FDA approval for patients who have not responded to more conservative treatments or cannot tolerate them. This study fulfills the post-approval requirements to monitor the devices performance over time. Participants in this study have already received the Neuspera SNM System implant during Phase I or Phase II of the prior study. The focus is on observing the devices effects and safety up to 72 months after implantation. No new treatments or placebo groups are involved, as this is a single-arm follow-up study of the approved device. During the study, participants will have regular follow-up visits to assess safety and effectiveness outcomes for up to six years after implantation. Researchers will monitor participants urinary symptoms and any device-related issues over time. The study is designed to collect comprehensive long-term data to better understand the devices ongoing impact and safety in real-world use.