192 Participants Needed

Heating Pad for Pain During Urological Testing

JS
JT
Overseen ByJasmine Tibon, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Heating Pad for pain during urological testing?

A study found that using a heating pad on the lower back area helped reduce pain and anxiety during a prostate biopsy, which is a type of urological test.12345

Is using a heating pad generally safe for humans?

Heating pads, also known as thermal therapy pads or warm compresses, are generally safe for humans. Studies on similar heat-based treatments for other conditions, like prostate issues, show mild side effects such as bladder spasms and discomfort, but no serious long-term problems.13678

How does the heating pad treatment for pain during urological testing differ from other treatments?

The heating pad treatment is unique because it uses localized heat application to reduce pain and anxiety during urological procedures, unlike other treatments that may involve medication or more invasive methods. This approach is non-invasive and focuses on comfort through warmth, which is different from standard pain management techniques.13789

Research Team

JT

Jasmine Tibon, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

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
I am 18 years old or older.

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.
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Timeline

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)

Treatment Details

Interventions

  • Heating Pad
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Heating Pad heatedExperimental Treatment1 Intervention
An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure
Group II: Placebo heating padPlacebo Group1 Intervention
An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Findings from Research

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

References

The Effect on Pain and Anxiety of Hot Pad Applied to Patients During Transrectal Prostate Biopsy. [2022]
Long-term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia results at three months through four years. [2013]
Elevation of sensory thresholds in the prostatic urethra after microwave thermotherapy. [2019]
Changes in pressure-flow parameters in patients treated with transurethral microwave thermotherapy. [2019]
Urinary colic during low-back treatment: out of the frying pan into the fire? [2011]
Transurethral hyperthermia for benign prostatic hyperplasia: preliminary clinical results. [2019]
Transurethral microwave hyperthermia for benign prostatic hyperplasia: preliminary clinical and pathological results. [2019]
Tolerability of high energy transurethral microwave thermotherapy with topical urethral anesthesia: results of a prospective, randomized, single-blinded clinical trial. [2023]
Warm sitz bath: are there benefits after transurethral resection of the prostate? [2021]