Urodynamic Testing: Can we Improve Patient Experience?

NCT02742389 | Completed

• 1 other identifier: 004-2016
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  Day 1

Study Arms (2)

Standard counseling

NO INTERVENTION

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

Standard + Preprocedure Telephone Call

OTHER

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

Interventions

Preprocedure Telephone Call 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

Standard + Preprocedure Telephone Call

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Presence of indwelling catheters
• History of prior Urodynamic Testing

Sponsors & Collaborators

• Boston Urogynecology Associates: lead
• Harvard University: collaborator

Study Sites (1)

Mount Auburn Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Study Officials

• Lekha Hota, MD

  Mount Auburn Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)