North Wales

This research aims to evaluate outcomes in women who have undergone surgery for vaginal or uterine prolapse using the GYNEMESH PS Mesh. It is a retrospective and prospective, single-arm, observational, multicenter, post-market study focusing on pelvic organ prolapse treatment results. There is no additional intervention in this study beyond the usual clinical care. The surgeries performed were standard procedures for apical vaginal or uterine prolapse, such as laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted methods, where the GYNEMESH PS Mesh was used as a bridging material following the instructions for use. Participants will be involved in follow-up assessments including physical examinations with Pelvic Organ Prolapse Quantification (POP-Q) to monitor changes from the time of surgery through the study's completion, which may last approximately seven years. Researchers will evaluate the long-term outcomes and safety of the mesh used in these surgical procedures.

Researchers are studying people with Irritable Bowel Syndrome (IBS) to find out if avoiding certain foods based on skin patch testing can help reduce their symptoms. The study tests for food allergies using a patch test that involves placing patches with 80 different foods and additives on the participant's back. The goal is to see if avoiding foods that cause allergic reactions improves IBS symptoms over 16 weeks. This is a randomized, double-blind trial where participants are assigned to either avoid foods they are allergic to or avoid foods they are not allergic to, without knowing which group they are in. The study involves three office visits within 4 to 5 days for the skin patch test. After 48 hours, the patches are removed and the doctor marks any allergic reactions. Participants with identified allergies then follow a 16-week avoidance diet. One group avoids the foods they reacted to (true avoidance diet), while the other group avoids different foods to which no allergy was found (sham avoidance diet). After the diet period, participants complete an online questionnaire about their IBS symptoms. Those on the sham diet will be informed of their true food allergies afterward and can try avoiding those foods on their own. During the study, participants complete questionnaires and follow dietary instructions for 16 weeks. Researchers measure IBS symptoms using a symptom assessment questionnaire after the avoidance diet. The total participation includes the initial patch testing visits, the 16-week diet period, and the final symptom questionnaire. The study results will be analyzed after all 250 participants complete the study to better understand the role of food allergies in IBS.

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 post-market clinical study focuses on women diagnosed with SUI confirmed by a positive cough stress test. The study aims to assess the long-term outcomes and safety of this continence device for surgical correction of SUI. Participants will undergo surgery using synthetic sub-urethral vaginal slings, which is the standard of care for treating primary stress urinary incontinence without additional prolapse surgery. There is no experimental intervention beyond the usual surgical procedure and clinical care. The study is designed as a single-arm follow-up to observe the device's performance over time. During the study, women will be monitored from post-surgery through follow-up visits spanning approximately 5 to 10 years. Researchers will assess changes using the Cough Stress Test (CST) to evaluate improvements in urinary incontinence. Participants will complete questionnaires and attend regular visits to track their condition and any safety concerns. The study emphasizes long-term observation to understand the continence system's sustained effectiveness and safety.

Researchers are evaluating the long-term safety and effectiveness of the Neuspera Sacral Neuromodulation (SNM) System for adults with urinary urge incontinence who have not responded to, could not tolerate, or were not candidates for other treatments. This post-approval study follows participants previously implanted with the Neuspera SNM System in earlier phases of the Neuspera SANS_UUI study. The study involves monitoring patients who received the Neuspera Implantable Sacral Neuromodulation System, which works by stimulating the sacral nerve. This device was implanted during Phase I or Phase II of the earlier study, and now participants are followed for up to 72 months after implantation to gather long-term data. During the study, participants will be regularly assessed to monitor the safety and effectiveness of the device over time. Researchers will collect data on outcomes related to urinary urge incontinence and any safety concerns up to 72 months post-implant. The study aims to provide important long-term information about the device's performance and participant well-being.