Heating Pad for in Office Cystoscopy and Urodynamic Testing

The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety; Distress, Emotional
• Intervention / Treatment: Device: Electrical heating pad; Device: Sham heating pad

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.

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Song, MD; Phone Number: 615-686-9648; Email: Songj5@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heating Pad heated; An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure	Device: Electrical heating pad; A powered heating pad; Other Names: Heating pad
Placebo Comparator: Placebo heating pad; An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure	Device: Sham heating pad; A heating pad that is not powered on; Other Names: Non-heated heating pad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pre- and Post-procedure (about 30 minutes)
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	Pre- and Post-procedure (about 30 minutes)
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	Pre- and Post-procedure (about 30 minutes)
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	Pre- and Post-procedure (about 30 minutes)
Blood pressure measure	Change in blood pressure	Pre- and Post-procedure (about 30 minutes)
Heart rate	Change in heart rate	Pre- and Post-procedure (about 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wait time	Amount of time spent waiting prior to procedure	Pre-procedure to beginning of procedure (about 30 minutes)
Time spent on procedure	Amount of time taken to complete procedure	Pre- to Post-procedure (about 30 minutes)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Jun Song, MD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 22, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cystoscopy; Urodynamic study
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: HSC20230455H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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