Heating Pad for Pain During Urological Testing

Overseen By Jasmine Tibon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Spinal cord injury, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a heated pad (also known as a Heating Pad) can reduce discomfort during urological tests like cystoscopy, which some patients avoid due to fear of pain. Participants will receive either a heated pad or a non-heated pad (placebo) before their procedure to assess any difference in comfort levels. Those who have delayed these tests due to pain concerns and can read and write English or Spanish might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance comfort during medical procedures.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the heating pad is safe for reducing discomfort during urological testing?

Research shows that heating pads are generally safe for people and often relieve pain by applying heat to the body. Studies have found that using a heating pad during procedures like cystoscopy or urodynamic studies can reduce anxiety, pain, and distress. These studies identified heating pads as a safe, simple, and effective way to manage discomfort. No major side effects have been reported when using heating pads in these situations, making them a low-risk option for easing discomfort during medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using heating pads for pain relief during urological tests because they offer a simple and non-invasive way to ease discomfort. Unlike medications, which can take time to kick in and often come with side effects, heating pads provide almost immediate relief by directly soothing the area with warmth. This method could be particularly beneficial for patients who need quick pain management during procedures like cystoscopies. By offering a drug-free alternative, heating pads could reduce the reliance on traditional pain medications and make these tests more comfortable for patients.

What evidence suggests that a heating pad is effective for reducing pain during urological testing?

This trial will compare the effects of a heated versus a placebo heating pad during urological testing. Research has shown that heating pads can reduce pain during procedures like cystoscopy and urodynamic studies. Patients who used heating pads reported significantly less pain, anxiety, and stress than those who did not. This likely occurs because heating pads improve blood flow and relax muscles, easing discomfort. Overall, evidence suggests that heating pads can make these procedures more comfortable. ^{1 2 3 4 6}

Who Is on the Research Team?

Jasmine Tibon, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

This trial is for adults who can consent and understand English or Spanish, needing cystoscopy or urodynamic tests but not other treatments like bladder biopsy at the same time. It's not for those refusing participation, with contraindications to these tests, or with spinal cord injuries/lack of sensation.

Inclusion Criteria

Able to read and write English or Spanish

Able to give informed consent

Exclusion Criteria

I have had procedures like bladder biopsy or Botox injections during my cystoscopy.

I do not wish to participate in the trial.

I cannot undergo bladder exams or bladder function tests due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of a heated or placebo heating pad prior to cystoscopy or urodynamic procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety, pain, and distress post-procedure

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Heating Pad

Trial Overview

The study is testing if using a heating pad reduces discomfort during cystoscopy or urodynamic studies compared to a sham (fake) heating pad. Participants will be randomly assigned to receive either the real or sham heating pad during their procedure.

How Is the Trial Designed?

Group I: Heating Pad heated Experimental Treatment 1 Intervention

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

Group II: Placebo heating pad Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

High energy transurethral microwave thermotherapy is well tolerated when performed with only topical urethral anesthesia, as shown in a study of 45 patients, indicating it can be safely administered in an outpatient setting without the need for systemic sedoanalgesia.

Patients experienced minimal pain during the procedure, with no significant difference in pain levels or treatment outcomes between those receiving topical anesthesia alone and those receiving additional sedoanalgesia, suggesting that topical anesthesia is sufficient for effective pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of high energy transurethral microwave thermotherapy with topical urethral anesthesia: results of a prospective, randomized, single-blinded clinical trial. Djavan, B., Shariat, S., Schäfer, B., et al.[2023]

Applying a heating pad to the sacral region during a transrectal prostate biopsy significantly reduced anxiety levels, as indicated by lower Beck Anxiety Inventory scores in the experimental group compared to the control group (p < .001).

Patients who received the heating pad also reported significantly less pain during the procedure, with lower visual analogue scale scores compared to those who did not receive the treatment (p = .016).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect on Pain and Anxiety of Hot Pad Applied to Patients During Transrectal Prostate Biopsy. Seyhan Ak, E., Culha, Y., Culha, MG., et al.[2022]

In a study involving 15 patients, transurethral microwave hyperthermia significantly improved urinary flow and reduced prostate size, with 12 patients experiencing substantial benefits in obstructive symptoms.

The treatment was generally safe, with only mild side effects reported, such as bladder spasms and dysuria, while the mechanism of action involved shrinking prostatic tissue to alleviate obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transurethral microwave hyperthermia for benign prostatic hyperplasia: preliminary clinical and pathological results. Baert, O., Ameye, F., Willemen, P., et al.[2019]

In a study of 1,783 patients who underwent transurethral resection of the prostate (TURP), those who used warm water sitz baths showed a lower incidence of postoperative complications, particularly urethral stricture, compared to those who did not use sitz baths (5.3% vs. 6.2%).

Patients who did not use warm water sitz baths had a 1.13-fold increased risk of rehospitalization within one month due to complications, suggesting that sitz baths may enhance recovery after TURP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Warm sitz bath: are there benefits after transurethral resection of the prostate? Park, SU., Lee, SH., Chung, YG., et al.[2021]

A case study of a 33-year-old man with lumbar discopathy showed that heat therapy, used during physical therapy, may have a beneficial effect on urinary symptoms, as he experienced improved urinary complaints after treatment.

The patient reported a change in pain nature after starting heat therapy, suggesting that heat may influence both musculoskeletal and urinary systems, highlighting the need for physicians to consider these effects in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary colic during low-back treatment: out of the frying pan into the fire? Kaymak, B., Ozçakar, L., Aksoy, S.[2011]

Cooled thermotherapy significantly improved lower urinary tract symptoms in 541 men over a follow-up period of up to 48 months, with a 55% reduction in the AUA symptom score and a 51% increase in peak urinary flow rate at 3 months, which persisted with only slight decreases over time.

More than 85% of men experienced at least a 25% improvement in their AUA symptom score and quality of life, demonstrating the long-term efficacy and durability of this treatment for benign prostatic hyperplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia results at three months through four years. Trock, BJ., Brotzman, M., Utz, WJ., et al.[2013]

Transurethral microwave thermotherapy (TUMT) significantly decreases sensitivity in the posterior urethra, which is associated with reduced urinary storage symptoms in men with benign prostatic hyperplasia.

In a study of 13 men, most reported satisfaction and a decrease in irritative symptoms, such as less frequent nighttime urination, after TUMT, with a notable correlation between increased sensory thresholds and symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elevation of sensory thresholds in the prostatic urethra after microwave thermotherapy. Brehmer, M., Nilsson, BY.[2019]

In a study of 75 patients with benign prostatic hyperplasia, transurethral microwave thermotherapy led to significant improvements in urinary flow rates and pressure-flow study parameters after 6 months.

Patients with constrictive obstruction showed the most notable benefits from the therapy, indicating they are the best candidates for this treatment compared to those with compressive obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in pressure-flow parameters in patients treated with transurethral microwave thermotherapy. de la Rosette, JJ., Tubaro, A., Trucchi, A., et al.[2019]

In a pilot study involving 21 patients with benign prostatic hyperplasia, transurethral microwave hyperthermia was found to be a safe treatment option, with only mild acute side effects like bladder spasms and hematuria, and no chronic complications observed.

The treatment led to significant improvements in urinary function, including increased urine flow and reduced nocturia, with only 3 out of 21 patients requiring further surgical intervention after a median follow-up of 12.5 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transurethral hyperthermia for benign prostatic hyperplasia: preliminary clinical results. Sapozink, MD., Boyd, SD., Astrahan, MA., et al.[2019]

Citations

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withpower.com

withpower.com/trial/phase-anxiety-disorders-8-2023-2e22e

Heating Pad for Pain During Urological Testing

Patients who received the heating pad also reported significantly less pain during the procedure, with lower visual analogue scale scores compared to those who ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29516595/

The effects of a heating pad on anxiety, pain, and distress ...

This study evaluated the effects of a heating pad on anxiety, pain, and distress during urodynamic studies in female patients with stress urinary incontinence.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30350117/

The use of a heating pad to reduce anxiety, pain, and ...

Conclusions: Using a heating pad during cystoscopy significantly reduced female patients' anxiety, pain, and distress. We found this to be a ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05981794/heating-pad-for-in-office-cystoscopy-and-urodynamic-testing

Heating Pad for in Office Cystoscopy and Urodynamic ...

Heating treatments are also known to reduce muscle pain by increasing local blood flow and decreasing distress. The use of a heating pad has ...

5.

researchgate.net

researchgate.net/publication/354791177_The_Effects_of_a_Heating_Pad_on_Patients'_Pain_Distress_and_Anxiety_during_Transrectal_Prostate_Biopsy

The Effects of a Heating Pad on Patients' Pain, Distress and ...

Impact of Heating Treatment on Pain, Anxiety, Vital Signs and Satisfaction in Rigid Cystoscopy Patients ... Effectiveness of stress management in patients ... data ...

6.

aetna.com

aetna.com/cpb/medical/data/500_599/0540.html

Heating Devices - Medical Clinical Policy Bulletins

No more than 1 heating device is considered medically necessary for each medical condition. Requests for multiple heating devices are subject to medical review.