Heating Pad for in Office Cystoscopy and Urodynamic Testing

The University of Texas System (UT)

Status: Enrolling

Conditions: Anxiety; Pain; Distress, Emotional

Treatments: Device: Sham heating pad; Device: Electrical heating pad

Study type: Interventional

Funder types: Other

Identifiers

NCT05981794

HSC20230455H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups, including a placebo group

Heating Pad heated

Experimental group

Description:

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

Treatment:

Device: Electrical heating pad

Placebo heating pad

Placebo Comparator group

Description:

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

Treatment:

Device: Sham heating pad