NCT07692789

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Dec 2027

Study Start

First participant enrolled

July 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 2, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    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.

    From enrollment to the end of the urodynamics study (less than 1 week)

Study Arms (2)

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.

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.

Interventions

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.

using patient reminder systems before scheduled urodynamics studies

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary Incontinence

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Central Study Contacts

Lisa Hickman, MD

CONTACT

Ashka Shah

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 9, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations