Heating Pad for in Office Cystoscopy and Urodynamic Testing

Last updated: August 15, 2024
Sponsor: The University of Texas Health Science Center at San Antonio
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Pain

Treatment

Electrical heating pad

Sham heating pad

Clinical Study ID

NCT05981794
HSC20230455H
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • Able to give informed consent

  • Able to read and write English or Spanish

Exclusion

Exclusion Criteria:

  • Refusal to participate

  • Contraindications to cystoscopy or urodynamic testing

  • Patients who receive other procedures or treatment at the time of cystoscopy, suchas bladder biopsy or Botox injection

  • Patients with spinal cord injury or lack of sensation

Study Design

Total Participants: 192
Treatment Group(s): 2
Primary Treatment: Electrical heating pad
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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