Lansdale

Researchers are evaluating the safety and effectiveness of the Desara4 One Single Incision Sling (SIS) compared to the Desara4 Blue sling system implanted via the transobturator route for treating women with stress urinary incontinence (SUI). This prospective, non-randomized, parallel cohort, multi-center study involves adult females clinically indicated for mid-urethral implant surgery due to SUI caused by urethral hypermobility and/or intrinsic sphincter deficiency. The study spans 36 months and includes follow-up visits at 2 and 6 weeks, and 6, 12, 18, 24, and 36 months. Participants receive either the Desara4 One Single Incision Sling or the Desara4 Blue Transobturator Sling, with 150 women in each group across up to 40 sites. The single incision sling is implanted via a minimally invasive approach, while the transobturator sling follows the standard mid-urethral sling procedure. Both devices are used to support the urethra and reduce urinary leakage. During the study, participants will attend scheduled follow-ups for clinical evaluations, including standing cough stress tests to assess treatment success, and monitoring for any serious adverse events related to the devices or procedures. Researchers will measure the success rate of negative stress tests and track safety outcomes over the full 36-month period, ensuring thorough long-term assessment of both treatment options.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.