Kidney StoneNCT07580391
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
A study testing WellPrept in people with Kidney Stone and Benign Prostatic Hyperplasia, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone, Benign Prostatic Hyperplasia
- What is being tested?
- WellPrept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with prostates measurements over 200g
- Patients who lack decisional capacity
- Patients who are non-English speakers
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Kidney Stone, Benign Prostatic Hyperplasia
- Being tested
- WellPrept, Standard Care
- Keywords
- HoLEP, kidney stones
- Medical subject headings
- Kidney Calculi, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellPreptOther
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.
Standard CareOther
Office based pathway without introducing the WellPrept website to patients
| Study group | Role | What they receive |
|---|---|---|
| Pre-WellPrept | Placebo comparator | (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. Receives: Other: Standard Care |
| Post-WellPrept | Active comparator | (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. Receives: Other: WellPrept; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative and post-operative literacy of either HoLEP for BPH or kidney stones.
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.
Measured: 1 year
Secondary outcomes (1)
Time spent in healthcare encounters
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start17 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
- Investigators
- Amy E Krambeck, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580391
- Sponsor's protocol ID
- STU00224476
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07580391
- Acronym / sponsor ID
- STU00224476
- Conditions
- Kidney Stone, Benign Prostatic Hyperplasia
- Keywords
- HoLEP, kidney stones
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-WellPrept | Placebo comparator | Other: Standard Care(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. |
| Post-WellPrept | Active comparator | Other: WellPrept, Other: Standard Care(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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with prostates measurements over 200g
- Patients who lack decisional capacity
- Patients who are non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WellPreptWellPrept 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. | Other | Post-WellPrept |
| Standard CareOffice based pathway without introducing the WellPrept website to patients | Other | Post-WellPrept, Pre-WellPrept |
Primary outcome
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 secondary outcome
Time spent in healthcare encounters
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy E Krambeck, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WellPrept in people with Kidney Stone and Benign Prostatic Hyperplasia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative and post-operative literacy of either HoLEP for BPH or kidney stones. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.