Clinical trial NCT05981794: Heating Pad for in Office Cystoscopy and Urodynamic Testing
Official title: The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Pain
Distress, Emotional
Keywords: Cystoscopy
Urodynamic study
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety visual analog scale (VAS)
timeFrame: Pre- and Post-procedure (about 30 minutes)
measure: Hospital Anxiety and Depression Survey (HADS)
timeFrame: Pre- and Post-procedure (about 30 minutes)
measure: Change in Pain (VAS)
timeFrame: Pre- and Post-procedure (about 30 minutes)
measure: Change in Distress (VAS)
timeFrame: Pre- and Post-procedure (about 30 minutes)
measure: Blood pressure measure
timeFrame: Pre- and Post-procedure (about 30 minutes)
measure: Heart rate
timeFrame: Pre- and Post-procedure (about 30 minutes)
Secondary outcomes:
measure: Wait time
timeFrame: Pre-procedure to beginning of procedure (about 30 minutes)
measure: Time spent on procedure
timeFrame: Pre- to Post-procedure (about 30 minutes)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Jasmine Tibon, MD
role: PRINCIPAL_INVESTIGATOR
References: