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Urodynamic Testing: Can we Improve Patient Experience?

Primary Purpose

Urinary Incontinence, Urinary Bladder, Overactive, Lower Urinary Tract Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preprocedure Telephone Call
Sponsored by
Boston Urogynecology Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Auburn Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Standard counseling

Standard + Preprocedure Telephone Call

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Overall pre-procedure anxiety as measured on a visual analog scale.
Overall pre-procedure anxiety as measured on a visual analog scale.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2016
Last Updated
January 17, 2018
Sponsor
Boston Urogynecology Associates
Collaborators
Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT02742389
Brief Title
Urodynamic Testing: Can we Improve Patient Experience?
Official Title
A Telephone Call to Decrease Patient Anxiety Before Urodynamic Testing: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Urogynecology Associates
Collaborators
Harvard University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urinary Bladder, Overactive, Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard counseling
Arm Type
No Intervention
Arm Description
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
Arm Title
Standard + Preprocedure Telephone Call
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Preprocedure Telephone Call
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall pre-procedure anxiety as measured on a visual analog scale.
Description
Overall pre-procedure anxiety as measured on a visual analog scale.
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or greater Female Patients who have decided to schedule Urodynamic Testing to follow-up lower urinary tract dysfunction, pelvic organ prolapse, and/or urinary incontinence Exclusion Criteria: Pregnant Presence of indwelling catheters History of prior Urodynamic Testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lekha Hota, MD
Organizational Affiliation
Mount Auburn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Auburn Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Urodynamic Testing: Can we Improve Patient Experience?

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