Pelvic Organ ProlapseNCT07692789
Improving Uroflowmetry Interpretability: Evaluating the Impact of Patient Reminder Systems
A study testing Patient reminder system in people with Pelvic Organ Prolapse and Urinary Incontinence, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of pre-procedure patient reminder systems on patient satisfaction, preparedness, and anxiety among patients undergoing urodynamics studies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Urinary Incontinence
- What is being tested?
- Patient reminder system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Ability to provide informed consent
- Documented post-residual volume of less than 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashka Shah contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Lisa Hickman, MD, 614-814-8205, Lisa.Hickman@osumc.edu
About this study
The purpose of this study is to evaluate the impact of pre-procedure patient reminder systems on patient satisfaction, preparedness, and anxiety among patients undergoing urodynamics studies. The rate of successful procedure completion will be compared between a prospective intervention group and a historical control group to determine whether the intervention improves procedural success and healthcare delivery.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence
- Being tested
- Patient reminder system
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient reminder systemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| using patient reminder systems before scheduled urodynamics studies | Experimental | 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. Receives: Other: Patient reminder system |
| not using patient reminder systems before scheduled urodynamics studies | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Completion failure is defined as a uroflow less than 150 mL
Measured: From enrollment to the end of the urodynamics study (less than 1 week)
Secondary outcomes (2)
Evaluate anxiety before and after a urodynamics (UDS) procedure after delivery of a patient reminder system.
Anxiety is measured by patient completion of ST-STAI before and after the UDS study.
Measured: 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.
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.
Measured: From enrollment to the end of the urodynamics study (less than 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Model description
- This study will use a prospective interventional cohort design with a historical control group. This design is appropriate because it allows evaluation of a low-risk, practical intervention within routine clinical workflows while enabling comparison to baseline outcomes. A historical cohort for the control group is used as the process of consenting patients into a control group could influence patient preparation and behavior, potentially altering the study outcomes.
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Hickman, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692789
- Sponsor's protocol ID
- STUDY20260760
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Uroflowmetry Interpretability: Evaluating the Impact of Patient Reminder Systems
- ClinicalTrials.gov ID
- NCT07692789
- Acronym / sponsor ID
- STUDY20260760
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jul 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 purpose of this study is to evaluate the impact of pre-procedure patient reminder systems on patient satisfaction, preparedness, and anxiety among patients undergoing urodynamics studies. The rate of successful procedure completion will be compared between a prospective intervention group and a historical control group to determine whether the intervention improves procedural success and healthcare delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a prospective interventional cohort design with a historical control group. This design is appropriate because it allows evaluation of a low-risk, practical intervention within routine clinical workflows while enabling comparison to baseline outcomes. A historical cohort for the control group is used as the process of consenting patients into a control group could influence patient preparation and behavior, potentially altering the study outcomes.
| Arm | Type | Receives |
|---|---|---|
| using patient reminder systems before scheduled urodynamics studies | Experimental | Other: Patient reminder systemThe 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. |
| not using patient reminder systems before scheduled urodynamics studies | No intervention | –Participants for the historical control group will be identified through retrospective review of electronic medical records of patients who previously underwent scheduled urodynamics studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Patient reminder systemUsing 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. | Other | using patient reminder systems before scheduled urodynamics studies |
Primary outcome
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
2 secondary outcomes
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)
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)
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 24 Sep 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.
Ashka Shah contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient reminder system in people with Pelvic Organ Prolapse and Urinary Incontinence, run by Ohio State 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Sep 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. 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?
Contact Lisa Hickman, MD (614-814-8205, Lisa.Hickman@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 24 Sep 2026.