Heating Pad for in Office Cystoscopy and Urodynamic Testing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety Pain Distress, Emotional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Heating Pad heated

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

Group Type EXPERIMENTAL

Electrical heating pad

Intervention Type DEVICE

A powered heating pad

Placebo heating pad

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

Group Type PLACEBO_COMPARATOR

Sham heating pad

Intervention Type DEVICE

A heating pad that is not powered on

Interventions

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Electrical heating pad

A powered heating pad

Intervention Type DEVICE

Sham heating pad

A heating pad that is not powered on

Intervention Type DEVICE

Other Intervention Names

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Heating pad Non-heated heating pad

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes