Lansdale

Researchers are evaluating the safety and effectiveness of the Desara4 One Single Incision Sling SIS compared to the Desara4 Blue sling system implanted through the transobturator-route TOR to treat women with stress urinary incontinence SUI. This study involves adult females experiencing SUI due to urethral hypermobility andor intrinsic sphincter deficiency ISD. The study is prospective, non-randomized, and conducted at multiple centers over 36 months. The study compares two devices the Desara4 One Single Incision Sling and the Desara4 Blue Transobturator Sling. Each device will be implanted in separate groups of 150 participants. Follow-up visits are scheduled at 2 and 6 weeks, then at 6, 12, 18, 24, and 36 months after implantation. Participants may also undergo concomitant laparoscopic, robotic, or vaginal prolapse repair surgeries if needed. Participants will attend regular visits for evaluations including cough stress tests, sexual function assessments, pain assessments, and urinary symptom improvements. Researchers will monitor serious adverse events related to the devices and procedures, as well as measure success rates of negative cough stress tests at 36 months. The total study participation spans three years with multiple assessments to track outcomes and safety.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.