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Heating Pad for in Office Cystoscopy and Urodynamic Testing

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05981794
Enrollment
0
Registered
2023-08-08
Start date
2025-01-31
Completion date
2027-12-31
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Distress, Emotional, Pain

Keywords

Cystoscopy, Urodynamic study

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.

Interventions

DEVICEElectrical heating pad

A powered heating pad

DEVICESham heating pad

A heating pad that is not powered on

Sponsors

The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Heart ratePre- and Post-procedure (about 30 minutes)Change in heart rate
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
Blood pressure measurePre- and Post-procedure (about 30 minutes)Change in blood pressure
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
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 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

MeasureTime frameDescription
Time spent on procedurePre- to Post-procedure (about 30 minutes)Amount of time taken to complete procedure
Wait timePre-procedure to beginning of procedure (about 30 minutes)Amount of time spent waiting prior to procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026