Urodynamic Testing: Can we Improve Patient Experience?

A Telephone Call to Decrease Patient Anxiety Before Urodynamic Testing: a Randomized Controlled Trial

The purpose of this study is to determine whether an intervention (pre-procedure telephone call by the investigators) will reduce anxiety in women undergoing urodynamic testing (UDT) compared to usual care. Our hypothesis is that women who receive the intervention will report less anxiety immediately before UDT than women who receive usual care.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Urinary Incontinence
• Intervention / Treatment: Other: Preprocedure Telephone Call

Detailed Description

This is a non-blinded, randomized controlled trial. The clinical trial will investigate whether a telephone call by the investigator one week prior to urodynamic testing (UDT) will decrease patient pre-procedure anxiety, improve patient-reported preparedness and increase satisfaction compared to usual care. Patients who are scheduled for UDT will be informed about the study. If the patient agrees to participate in the study, she will be randomized to one of 2 groups based on the week of her scheduled UDT.

Group 1: Standard counseling. This group will receive the standard counseling that all Boston Urogynecology Associates (BUA) patients would receive if they are scheduled to have urodynamic testing. This counseling will include a description of the procedure and a handout about urodynamic testing. On the day of their test the participants will be asked to complete a brief survey about their experience before and after their testing. The investigators will also collect some information from their medical record, such as age and prior urogynecologic procedures.

Group 2: Standard counseling plus the intervention. The participants assigned to be in the intervention group will receive the standard counseling that all BUA patients who are scheduled for urodynamic testing receive (just like those who are assigned to group 1). This counseling includes a description of the procedure and a handout about urodynamic testing. In addition, the participants will receive a phone call from the investigators 1 week before their testing to talk about the procedure. The investigator calling the participant will document the duration of the phone call and any questions asked by the participant. On the day of their test the participants will be asked to complete the same surveys as group 1.

Surveys given to the participants on the day of their UDT appointment will include:

1. A pre-UDT questionnaire that includes questions on demographics, overall anxiety, anxiety about specific elements of procedure, self-reported preparedness and satisfaction.
2. A brief post-UDT questionnaire addressing test experience and pain.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Mount Auburn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. 18 years or greater
2. Female
3. Patients who have decided to schedule Urodynamic Testing to follow-up lower urinary tract dysfunction, pelvic organ prolapse, and/or urinary incontinence

Exclusion Criteria:

1. Pregnant
2. Presence of indwelling catheters
3. History of prior Urodynamic Testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard counseling; This group will receive the standard counseling that all our patients would receive if they are scheduled to have urodynamic testing. This counseling will include a description of the procedure and a handout about urodynamic testing
Other: Standard + Preprocedure Telephone Call; The participants will receive the standard counseling that all our patients who are scheduled for urodynamic testing receive (just like those who are assigned to group 1). In addition, the participants will receive intervention: a pre-procedural telephone call from the investigators 1 week before their testing to talk about the procedure.	Other: Preprocedure Telephone Call; The participants will receive a phone call from the investigators 1 week before their testing to talk about the procedure and answer any questions that patients may have . The investigator calling the participant will document the duration of the phone call and any questions asked by the participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall pre-procedure anxiety as measured on a visual analog scale.	Overall pre-procedure anxiety as measured on a visual analog scale.	Day 1

Collaborators and Investigators

• Sponsor: Boston Urogynecology Associates
• Collaborators: Harvard University
• Investigators: Principal Investigator: Lekha Hota, MD, Mount Auburn Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 004-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO