- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07580391
Utilization of a Web-Based Application to Improve Patient Health Literacy and Reduce Clinic Visit Times in Holmium Laser Enucleation of the Prostate (HoLEP) Procedures and Kidney Stone Surgery
May 5, 2026 updated by: Amy Krambeck, Northwestern University
The investigator and research team plan to investigate whether patients who receive access to WellPrept website will report greater confidence and understanding of their medical condition, have shorter clinic visit times, and fewer post-operative trips to the emergency room.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- In the HoLEP arm, men aged 18-100 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates.
- In the Kidney stone arm, men and women aged 18-100 who are undergoing surgery for the treatment of stones in the kidney, urinary tract, or bladder.
Exclusion Criteria:
- Patients with prostates measurements over 200g
- Patients who lack decisional capacity
- Patients who are non-English speakers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Pre-WellPrept
(Standard Care) Participants enrolled in this arm will not receive access to the WellPrept website containing information about the condition and treatments offered before their consultation regarding BPH/HoLEP and/or kidney stones.
|
Office based pathway without introducing the WellPrept website to patients
|
|
Active Comparator: Post-WellPrept
(Standard care + WellPrept website) Participants enrolled in this arm will receive access to the WellPrept website containing information about the condition and treatments offered before their consultation regarding BPH/HoLEP and/or kidney stones.
|
Office based pathway without introducing the WellPrept website to patients
WellPrept is a web-based application created by urologist David Canes to streamline doctor-patient interactions by allowing patients to arrive to their visits well prepared.
The idea behind WellPrept is that by providing clear health information ahead of time to patients, that overall patient health literacy will increase, and doctor-patient interactions can be streamlined.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-operative and post-operative literacy of either HoLEP for BPH or kidney stones.
Time Frame: 1 year
|
Comparing pre-operative and post-operative literacy of either HoLEP for BPH, after WellPrept.
This will be conducted through a questionnaire sent to patients before and after their procedure as well as to the clinician who will be conducting patient follow-ups in order to gauge reported patient understanding from the clinical team and from the patient.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time spent in healthcare encounters
Time Frame: 1 year
|
Comparing time spent (minutes) in healthcare encounters, specifically during clinic visits, pre-operative and post-operative visits, and number of visits to the emergency room after their procedure.
This will be determined by timing clinic visits and using the medical record to assess visits to the emergency room.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy E Krambeck, MD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
April 26, 2026
First Submitted That Met QC Criteria
May 5, 2026
First Posted (Actual)
May 12, 2026
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 5, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Prostatic Hyperplasia
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- STU00224476
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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