Urodynamic Testing: Can we Improve Patient Experience?

NCT ID: NCT02742389

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-06-30

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:

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: OTHER

Preprocedure Telephone Call

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Harvard University

OTHER

Sponsor Role: collaborator

Boston Urogynecology Associates

OTHER

Sponsor Role: lead

Responsible Party

Lekha S. Hota

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lekha Hota, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Auburn Hospital

Locations

Mount Auburn Hospital

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

004-2016

Identifier Type: -

Identifier Source: org_study_id