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

192 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 7 8 9}

Research Team

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.

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 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.

Participant Groups

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+

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).

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effect on Pain and Anxiety of Hot Pad Applied to Patients During Transrectal Prostate Biopsy. [2022]

2. United States 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. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Elevation of sensory thresholds in the prostatic urethra after microwave thermotherapy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Changes in pressure-flow parameters in patients treated with transurethral microwave thermotherapy. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Urinary colic during low-back treatment: out of the frying pan into the fire? [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Transurethral hyperthermia for benign prostatic hyperplasia: preliminary clinical results. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Transurethral microwave hyperthermia for benign prostatic hyperplasia: preliminary clinical and pathological results. [2019]

8. United States 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. [2023]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Warm sitz bath: are there benefits after transurethral resection of the prostate? [2021]