Heating Pad for in Office Cystoscopy and Urodynamic Testing

Not Applicable

Withdrawn

• Conditions: Anxiety; Distress, Emotional; Pain
• Interventions: Device: Electrical heating pad; Device: Sham heating pad

• Registration Number: NCT05981794
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study First Submitted: 2023-07-22
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-08
• Study Start: 2025-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-01
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heating Pad heated	Electrical heating pad	An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure
Placebo heating pad	Sham heating pad	An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Survey (HADS)	Pre- and Post-procedure (about 30 minutes)	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 Distress (VAS)	Pre- and Post-procedure (about 30 minutes)	Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest
Heart rate	Pre- and Post-procedure (about 30 minutes)	Change in heart rate
Anxiety visual analog scale (VAS)	Pre- and Post-procedure (about 30 minutes)	Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest
Blood pressure measure	Pre- and Post-procedure (about 30 minutes)	Change in blood pressure
Change in Pain (VAS)	Pre- and Post-procedure (about 30 minutes)	Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest

Secondary Outcome Measures

Name	Time	Method
Time spent on procedure	Pre- to Post-procedure (about 30 minutes)	Amount of time taken to complete procedure
Wait time	Pre-procedure to beginning of procedure (about 30 minutes)	Amount of time spent waiting prior to procedure

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States