Do not index
Do not index
Trial Description
A Real-World Study of eCoin® for Urgency Urinary Incontinence: Post-Approval Evaluation (NCT05685433) is being conducted by Valencia Technologies to evaluate the safety and effectiveness of the FDA-approved eCoin® tibial nerve stimulator in real-world clinical practice.
The eCoin® device is a small, coin-sized implantable neurostimulator designed to treat urge urinary incontinence (UUI). It is placed beneath the skin near the ankle through a minimally invasive procedure and automatically delivers periodic stimulation to the tibial nerve twice per week. This gentle, scheduled stimulation helps improve bladder control with minimal ongoing effort from the patient.
“Many patients suffering from the embarrassment and anxiety of living with overactive bladder want an alternative to costly medications and other more involved treatments. With the eCoin system, I can offer urge urinary incontinence patients an effective alternative with a single procedure, few office visits, and ‘set it and forget it’ convenience.”
Jason Kim, M.D. of Stony Brook Medicine
Clinic Description
Urology of Centers of Alabama is a leading urology practice with over 70 years of experience providing advanced, compassionate care for urological disorders using cutting-edge technologies such as minimally invasive robotic surgery. They are also deeply involved in clinical research, conducting trials focused on innovative treatments and new drugs to improve patients outcomes in urology.
Challenge
Urology of Centers of Alabama (UCA) was participating as an investigative site for the eCoin clinical trial. Upon receiving its enrollment target for the study, the UCA research team immediately experienced significant pressure. They knew that eligible patients were in their EHR system, but finding them meant manually combing through thousands of charts, lab results, and clinical notes.
The study’s complex inclusion and exclusion criteria made manual review extremely time-consuming. Each research coordinator was reviewing hundreds of records one by one, searching for patients who met highly specific requirements, such as urgency urinary incontinence episode for three consecutive days as documented in a voiding diary, while also ruling out disqualifying factors like abnormal post-void residual (>150cc). These criteria were often buried deep within clinical documentation, scattered across multiple encounters and data types.
Furthermore, their EHR’s native reporting tools could only surface broad patient populations and lacked the precision to filter for the complex inclusion and exclusion criteria required for the trial.
UCA needed a solution that could search across both structured and unstructured clinical data, apply complex inclusion and exclusion logic, and deliver qualified candidates directly to their coordinators, without overwhelming them with false positives.
“By the time a potentially eligible patient was found, that patient had often already started another treatment or exited the eligibility window.”
Meredith Sharpton, PA-C
Director of Clinical Research at Urology Centers of Alabama.
Solution
Urology Centers of Alabama (UCA) selected HealthKey to accelerate both its clinical trial screening workflows and operational efficiency.
HealthKey offered more advanced capabilities to help UCA get eligible patients for clinical trials. HealthKey’s platform connected with UCA’s Veradigm AllScripts EHR system within minutes. Once connected, clinical research coordinators at UCA uploaded the clinical trial protocol. Then, HealthKey’s system would convert inclusion and exclusion criteria of the trials into logic the AI could apply across both structured fields and unstructured clinical notes.
HealthKey processed 22,000 patient records, 2.1 million data points, and returned a list of eligible patients within 24 hours. Each match included direct links to the supporting evidence.
Patients who were close but required human judgment — perhaps the voiding diary showed only two consecutive days of urgency incontinence, or the post-void residual measurement was documented ambiguously — were flagged separately. Coordinators could review those cases without wading through hundreds of charts that clearly didn't qualify.
From what took months and years to manually screen through every single patient, HealthKey’s system was able to process patients and millions of healthcare information under just weeks.
The Results
22,000 patients and 2.1 million medical records processed under 24 hours.
In order to process this amount of patients and medical records, for the 4 clinical research coordinators that Urology Centers of Alabama had, that would have taken them over 3 years to do this manually.
28 eligible patients matched, enrollment target met.
Manual screening made it nearly impossible to find eligible patients—they have been searching for patients for this trial since April of 2024, and the only ones they were able to enroll were from patients from a sister-study. However, with using HealthKey, they were able to find 28 net new eligible patients in their EHR system. In the 6 weeks thereafter, UCA was able to enroll enough patients to meet their enrollment target.
“HealthKey found so many eligible patients that we had to pause processing to give our team time to reach out,” said Meredith. “It completely changed how we approach recruitment.”
Looking Ahead
With their enrollment goals achieved, Urology Centers of Alabama has made HealthKey a cornerstone of their recruitment strategy. The organization has since met enrollment targets for four additional clinical trials and is active leveraging HealthKey to drive recruitment for additional ongoing studies. With faster, more accurate patient identification, and improved sponsor satisfaction, HealthKey has become essential to Urology Centers of Alabama’s continued research growth.
Written by
