Heating Pad for in Office Cystoscopy and Urodynamic Testing

Study Overview
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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.

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.

Official Title
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The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial

Conditions
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Pain, Anxiety, Distress, Emotional

Intervention / Treatment
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* Device: Electrical heating pad
* Device: Sham heating pad


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heating Pad heated<br>An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure | Device: Electrical heating pad<br>* A powered heating pad<br>* Other names: Heating pad;|
| Placebo Comparator: Placebo heating pad<br>An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure | Device: Sham heating pad<br>* A heating pad that is not powered on<br>* Other names: Non-heated heating pad;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wait time | Amount of time spent waiting prior to procedure | Pre-procedure to beginning of procedure (about 30 minutes) | 
| Time spent on procedure | Amount of time taken to complete procedure | Pre- to Post-procedure (about 30 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystoscopy, Urodynamic study