search
Back to results

Heating Pad for in Office Cystoscopy and Urodynamic Testing

Primary Purpose

Anxiety, Pain, Distress, Emotional

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical heating pad
Sham heating pad
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Cystoscopy, Urodynamic study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 years or older Able to give informed consent Able to read and write English or Spanish Exclusion Criteria: Refusal to participate Contraindications to cystoscopy or urodynamic testing Patients who receive other procedures or treatment at the time of cystoscopy, such as bladder biopsy or Botox injection Patients with spinal cord injury or lack of sensation

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Heating Pad heated

Placebo heating pad

Arm Description

An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure

An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure

Outcomes

Primary Outcome Measures

Anxiety visual analog scale (VAS)
Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest
Hospital Anxiety and Depression Survey (HADS)
Change in score on the anxiety subscale score, a total score of 0-21 is possible, with a score between 0-7= Normal, 8-10= Borderline abnormal and 11-21= abnormal
Change in Pain (VAS)
Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest
Change in Distress (VAS)
Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest
Blood pressure measure
Change in blood pressure
Heart rate
Change in heart rate

Secondary Outcome Measures

Wait time
Amount of time spent waiting prior to procedure
Time spent on procedure
Amount of time taken to complete procedure

Full Information

First Posted
July 22, 2023
Last Updated
July 31, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
search

1. Study Identification

Unique Protocol Identification Number
NCT05981794
Brief Title
Heating Pad for in Office Cystoscopy and Urodynamic Testing
Official Title
The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patient frequently report experiencing discomfort associated with cystoscopy or urodynamic studies (UDS), and a small percentage of patients refuse these important procedures due to discomfort or fear of discomfort. Heating pads are an inexpensive and low-risk way to reduce patient discomfort during these procedures, which to our knowledge has not been investigated in the United States.
Detailed Description
Invasive office procedures such as cystoscopy and urodynamic studies (UDS) are commonly performed for many urologic and Urogynecologic conditions including, but not limited to, incontinence, voiding dysfunction, urinary retention, hematuria, and other lower urinary tract symptoms. Cystoscopy involves the insertion of a rigid or flexible cystoscope through the urethra and into the bladder. Urodynamic studies involve the placement of urethral and rectal catheters. Both cystoscopy and UDS involve filling the bladder with fluid, and these procedures are essential to the diagnosis and management of many of the conditions listed above. While both procedures are office procedures that are generally well tolerated, some patients can experience significant discomfort, pain, or anxiety. Some nonpharmacologic therapies have been investigated to relieve anxiety, pain, and distress, such as music and aromatherapy. Heating treatments are also known to reduce muscle pain by increasing local blood flow and decreasing distress. The use of a heating pad has become an established complementary modality in some invasive procedures. A previous study from South Korea has shown benefit of heating pad use for anxiety, pain, and distress during cystoscopy and UDS; however to our knowledge, there are no studies evaluating the effect of heating pad use on patients in the United States, who may have inherent demographical differences compared to patients from South Korea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Distress, Emotional
Keywords
Cystoscopy, Urodynamic study

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized in a 1:1 manner to the treatment group (those receiving a heating pad with heat during the procedure) or control group (those who receive a heating pad without heat). The study is prospective, and randomization will be performed by a random allocation table. Randomization will be stratified by sex, procedure, and provider.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heating Pad heated
Arm Type
Experimental
Arm Description
An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure
Arm Title
Placebo heating pad
Arm Type
Placebo Comparator
Arm Description
An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure
Intervention Type
Device
Intervention Name(s)
Electrical heating pad
Other Intervention Name(s)
Heating pad
Intervention Description
A powered heating pad
Intervention Type
Device
Intervention Name(s)
Sham heating pad
Other Intervention Name(s)
Non-heated heating pad
Intervention Description
A heating pad that is not powered on
Primary Outcome Measure Information:
Title
Anxiety visual analog scale (VAS)
Description
Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest
Time Frame
Pre- and Post-procedure (about 30 minutes)
Title
Hospital Anxiety and Depression Survey (HADS)
Description
Change in score on the anxiety subscale score, a total score of 0-21 is possible, with a score between 0-7= Normal, 8-10= Borderline abnormal and 11-21= abnormal
Time Frame
Pre- and Post-procedure (about 30 minutes)
Title
Change in Pain (VAS)
Description
Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest
Time Frame
Pre- and Post-procedure (about 30 minutes)
Title
Change in Distress (VAS)
Description
Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest
Time Frame
Pre- and Post-procedure (about 30 minutes)
Title
Blood pressure measure
Description
Change in blood pressure
Time Frame
Pre- and Post-procedure (about 30 minutes)
Title
Heart rate
Description
Change in heart rate
Time Frame
Pre- and Post-procedure (about 30 minutes)
Secondary Outcome Measure Information:
Title
Wait time
Description
Amount of time spent waiting prior to procedure
Time Frame
Pre-procedure to beginning of procedure (about 30 minutes)
Title
Time spent on procedure
Description
Amount of time taken to complete procedure
Time Frame
Pre- to Post-procedure (about 30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older Able to give informed consent Able to read and write English or Spanish Exclusion Criteria: Refusal to participate Contraindications to cystoscopy or urodynamic testing Patients who receive other procedures or treatment at the time of cystoscopy, such as bladder biopsy or Botox injection Patients with spinal cord injury or lack of sensation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Song, MD
Phone
615-686-9648
Email
Songj5@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Song, MD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All de-identified IPD that underlie results in a publication
IPD Sharing Time Frame
When summary data are published or otherwise made available at study completion

Learn more about this trial

Heating Pad for in Office Cystoscopy and Urodynamic Testing

We'll reach out to this number within 24 hrs