Owings Mills

This research aims to evaluate the safety and performance of the Glean Urodynamics System for monitoring lower urinary tract function. It is a prospective, open-label, single arm interventional trial involving adult patients eligible for urodynamics testing. The study focuses on conditions related to urinary bladder overactivity, benign prostatic hyperplasia, urinary incontinence, and other lower urinary tract dysfunctions. Participants will have the Glean Urodynamics System inserted during an in-clinic ambulatory monitoring period. After this, they will be discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, for no longer than 24 hours. The sensor will be removed within 24 hours of insertion. Seven days after sensor removal, participants will provide a urine sample, and they will receive a follow-up phone call 14 days post-removal to assess any adverse events. During the study, researchers will monitor participants from enrollment until 14 days after device removal for any qualifying adverse events related to the device. The study includes collection of urine samples and follow-up communications to ensure participant safety. Participants are expected to be involved in the monitoring period, sample collection, and follow-up assessments over a total duration spanning approximately two weeks after device removal.

Researchers are evaluating the safety and effectiveness of the FemPulse System, a non-implanted electrical stimulation device, for treating Overactive Bladder (OAB) in females aged 21 or older. OAB is characterized by symptoms such as urinary urgency, frequency, nocturia, and sometimes urgency urinary incontinence. Participants must have had OAB symptoms for more than six months confirmed by a physician. The study compares two groups: one using the non-implanted vaginal electrical stimulation device called FemPulse, and the other receiving standard OAB medication. The study monitors participants over a period focusing on changes in the average number of times they urinate per day, with treatments and procedures designed to assess the device and medication effects on bladder symptoms. Participants will be asked to comply with study procedures including medication adherence, fluid intake regulation, and diary completion to track symptoms. Researchers will measure the mean change in voids per day over six months. Safety and effectiveness will be monitored throughout the study, with assessments guided by the study team to ensure proper participation and data collection.

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.