Do not index
Do not index
Quick tags
- Site:
Urology Centers of Alabama
- Sponsor:
Valencia Technologies
- Indication:
Urinary Incontinence
- Specialty:
Urology
- Type:
Device
- EHR:
Veradigm Allscripts
Trial Description
The RECIPE study (NCT05685433) is a prospective, multicenter, single-arm study evaluating the safety and effectiveness of the FDA-approved eCoin tibial nerve stimulator in real-world clinical practice. The study is sponsored by Valencia Technologies Corporation and aims to enroll 200 patients across 22 sites nationwide.
The eCoin device is a small, coin-sized implantable neurostimulator designed to treat urgency 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. The primary endpoints measure the proportion of subjects achieving at least 50% improvement in UUI episodes, along with the rate of device or procedure-related adverse events at 12 months.
“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 Centers of Alabama (UCA) 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 patient outcomes in urology.
Challenge
Urology Centers of Alabama 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 inclusion and exclusion criteria made manual review extremely time-consuming. The trial required evaluating 20 distinct eligibility criteria spanning diagnosis confirmation, voiding diary documentation, medication history, surgical history, lab results, and clinical assessments. Each research coordinator was reviewing hundreds of records one by one, searching for patients who met highly specific requirements, such as urgency urinary incontinence episodes for three consecutive days as documented in a voiding diary, while also ruling out disqualifying factors like abnormal post-void residual (>200cc), uncontrolled diabetes (HbA1c >7), or the presence of implantable neurostimulators.
With 20 criteria to evaluate per patient and clinical details scattered across structured fields and unstructured notes, their EHR's native reporting tools could only surface broad patient populations. The tools lacked the precision to filter for the complex inclusion and exclusion criteria required for the trial.
“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 selected HealthKey to accelerate their clinical trial screening workflows.
HealthKey connected to UCA's Veradigm Allscripts EHR system within minutes. Once connected, clinical research coordinators uploaded the clinical trial protocol. HealthKey's platform translated the trial's 20 inclusion and exclusion criteria into logic the AI could apply across both structured fields and unstructured clinical notes.
HealthKey processed 2.4M medical records across 22,701 patients, performing 27,656 individual criteria evaluations, and found 68 patients who met all 20 eligibility criteria, along with near-matches that required human judgment. Each match included direct links to the supporting evidence: the voiding diary entries confirming three consecutive days of UUI episodes, the medication history verifying prior treatment attempts, and the lab results ruling out disqualifying conditions.
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 thousands of charts that clearly didn't qualify.
The Results
22,701 patients screened and 2.4 million medical records processed.
HealthKey screened 22,701 patients and processed 2,375,726 medical records, evaluating each patient against 20 eligibility criteria. For UCA's clinical research team, manually reviewing this volume would have required approximately 6,810 hours, or over 851 full working days.
68 eligible patients identified, 3 more enrolled in weeks.
Manual screening made it nearly impossible to find eligible patients. UCA had been searching for patients for this trial since April 2024, and the only ones they were able to enroll were from patients from a sister study. With HealthKey, 68 patients met all 20 eligibility criteria. UCA contacted 7 patients and enrolled 3 more within weeks of recieving the matched list.
“HealthKey found so many eligible patients that we had to pause processing to give our team time to reach out. It completely changed how we approach recruitment.”
Meredith Sharpton, PA-C, Director of Clinical Research at Urology Centers of Alabama
Looking Ahead
With their enrollment progress accelerated, 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. UCA is actively leveraging HealthKey to drive recruitment for additional ongoing studies, with faster and more accurate patient identification improving both coordinator efficiency and sponsor satisfaction.
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