Heating Pad for in Office Cystoscopy and Urodynamic Testing

NCT05981794 | Withdrawn FDA Device

• 1 other identifier: HSC20230455H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Distress, Emotional

Keywords

Cystoscopy; Urodynamic study

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Wait time

  Pre-procedure to beginning of procedure (about 30 minutes)

• Time spent on procedure

  Pre- to Post-procedure (about 30 minutes)

Study Arms (2)

Heating Pad heated

EXPERIMENTAL

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

Device: Electrical heating pad

Placebo heating pad

PLACEBO COMPARATOR

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

Device: Sham heating pad

Interventions

Electrical heating pad DEVICE

A powered heating pad

Also known as: Heating pad

Heating Pad heated

Sham heating pad DEVICE

A heating pad that is not powered on

Also known as: Non-heated heating pad

Placebo heating pad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Able to give informed consent
• Able to read and write English or Spanish

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jasmine Tibon, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: August 8, 2023
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When summary data are published or otherwise made available at study completion

Locations

US (1)