- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07692789
Improving Uroflowmetry Interpretability: Evaluating the Impact of Patient Reminder Systems
July 2, 2026 updated by: Lisa Hickman, Ohio State University
The purpose of this study is to compare the rate of successful urodynamics procedure completion between a prospective intervention group and a historical control group after a pre-procedure patient reminder system to determine whether the intervention improves procedural success and healthcare delivery.
The impact of the reminder system on patient satisfaction, preparedness, and anxiety will also be evaluated.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
162
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 Contact
- Name: Lisa Hickman, MD
- Phone Number: 614-814-8205
- Email: Lisa.Hickman@osumc.edu
Study Contact Backup
- Name: Ashka Shah
- Email: Ashka.Shah@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Wexner Medical Center
-
Contact:
- Lisa Hickman, MD
- Phone Number: 614-814-8205
- Email: Lisa.Hickman@osumc.edu
-
-
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
No
Description
Inclusion Criteria
- Age 18 years or older
- Sex assigned at birth: Female.
- English-speaking
- Scheduled to undergo a urodynamics study at the OSU Upper Arlington Outpatient Clinic, OSU New Albany Outpatient Clinic, or OSU Eye and Ear Institute
- Ability to access a telephone
- Active MyChart account
- Ability to provide informed consent
- Documented post-residual volume of 150 mL
- Ability to be reached by telephone after three call attempts
- Negative point-of-care urinary tract infection on the day of the scheduled procedure (SOC)
Exclusion criteria:
- Under 18 years of age
- Patients with structural causes of urinary retention/incomplete bladder emptying (defined as a post-void residual >150ml) or a positive point-of-care urinary tract infection on the day of the procedure.
- Men are excluded as the population of interest is the female urogynecology population in both urology and obstetrics and gynecology.
- Patients without access to a telephone or an active MyChart account are excluded because the intervention relies on telephone calls and electronic messaging for delivery of pre-procedure education and reminders.
- Individuals who cannot be reached by telephone are excluded because they cannot receive the intervention.
- Non-English speaking individuals are excluded because they will not be able to receive the standardized phone call in English and will not be able to complete the informed consent.
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 |
|---|---|
|
Experimental: using patient reminder systems before scheduled urodynamics studies
The study intervention will include all participating patients receiving a phone call from a study team member reading from a script before their scheduled appointment.
The phone call will involve consenting the patient for the study and a reminder to come in for the study with a comfortably full bladder, avoiding utilizing the lobby restroom before the appointment.
|
Using patient reminder systems before scheduled urodynamics studies on patient satisfaction, preparedness, anxiety, and successful completion of the procedure to improve healthcare delivery by comparing a prospective intervention group with a historical control group.
|
|
No Intervention: not using patient reminder systems before scheduled urodynamics studies
Participants for the historical control group will be identified through retrospective review of electronic medical records of patients who previously underwent scheduled urodynamics studies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent decrease in urodynamics procedure completion failure rate in patients who received the reminder system before scheduled urodynamics procedures vs. patients who did not receive the reminder
Time Frame: From enrollment to the end of the urodynamics study (less than 1 week)
|
Completion failure is defined as a uroflow less than 150 mL
|
From enrollment to the end of the urodynamics study (less than 1 week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate anxiety before and after a urodynamics (UDS) procedure after delivery of a patient reminder system.
Time Frame: From enrollment to the end of the urodynamics study (less than 1 week)
|
Anxiety is measured by patient completion of ST-STAI before and after the UDS study.
|
From enrollment to the end of the urodynamics study (less than 1 week)
|
|
Evaluate patient satisfaction and preparedness before and after a urodynamic study after delivery of a patient reminder system.
Time Frame: From enrollment to the end of the urodynamics study (less than 1 week)
|
Patient satisfaction and preparedness for the procedure will be assessed using Likert-style items via a survey issued to patients before and after the UDS study.
|
From enrollment to the end of the urodynamics study (less than 1 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
July 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
July 2, 2026
First Submitted That Met QC Criteria
July 2, 2026
First Posted (Actual)
July 9, 2026
Study Record Updates
Last Update Posted (Actual)
July 9, 2026
Last Update Submitted That Met QC Criteria
July 2, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Pathological Conditions, Anatomical
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Prolapse
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
- Pelvic Organ Prolapse
Other Study ID Numbers
- STUDY20260760
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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