Heating Pad for Pain During Urological Testing
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Disqualifiers: Spinal cord injury, others
Approved in 2 Jurisdictions
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.
12345Is 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.
13678How 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.
13789Eligibility 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.
+1 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Texas Health Science Center at San AntonioSan Antonio, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
References
The Effect on Pain and Anxiety of Hot Pad Applied to Patients During Transrectal Prostate Biopsy. [2022]The aim of the study was to evaluate the effect of the application of a heating pad on the sacral region on pain and anxiety during a transrectal prostate biopsy.
Long-term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia results at three months through four years. [2013]To determine the long-term efficacy of cooled thermotherapy in the treatment of lower urinary tract symptoms of clinical benign prostatic hyperplasia.
Elevation of sensory thresholds in the prostatic urethra after microwave thermotherapy. [2019]To determine whether transurethral microwave thermotherapy (TUMT) affects the sensory threshold in the posterior urethra and whether such an effect influences urinary storage symptoms.
Changes in pressure-flow parameters in patients treated with transurethral microwave thermotherapy. [2019]We document changes in pressure-flow study parameters in patients treated by transurethral microwave thermotherapy.
Urinary colic during low-back treatment: out of the frying pan into the fire? [2011]The objective of this study was to present a possible discrete effect of heat therapy on the urinary system during physical therapy of a patient with lumbar discopathy.
Transurethral hyperthermia for benign prostatic hyperplasia: preliminary clinical results. [2019]A total of 21 patients with biopsy proved benign prostatic hyperplasia underwent treatment on a pilot protocol involving intracavitary transurethral radiating microwave (630 or 915 MHz.) antenna hyperthermia. Acute and subacute toxicity was mild and consisted primarily of bladder spasm (26% of the patients), hematuria (23%) and dysuria (9%), none of which significantly limited the achievement of desired temperatures during the treatment sessions. No chronic treatment-related morbidity or mortality was observed. Detailed thermal mapping, performed along the course of the prostatic urethra, recorded temperatures of 43C or more at greater than 75% of the loci. Highly significant increases in urine flow rate, decrease in post-void residual urine capacity and decrease in frequency of nocturia were observed. A marginally significant decrease in prostate volume was noted and, with a median followup of 12.5 months, only 3 patients have required subsequent prostatic resection. Transurethral hyperthermia represents a safe and promising outpatient approach to treatment of benign prostatic hyperplasia, particularly for patients who are not candidates for conventional surgical approaches because of medical or personal reasons. Further studies with the goal of optimizing the technique appear to be warranted, although long-term results would be best evaluated with prospective phase 3 trials.
Transurethral microwave hyperthermia for benign prostatic hyperplasia: preliminary clinical and pathological results. [2019]Transurethral microwave hyperthermia is a new conservative treatment modality for benign prostatic hyperplasia. We treated 15 patients with 915 MHz. microwaves delivered transurethrally by a helical applicator. Of the patients 12 showed substantial objective and subjective improvement of obstructive outflow parameters. Significant improvement in objective study parameters included increased mean flow rate (p less than 0.00021), decreased mean residual volume (p less than 0.00001) and decreased mean prostatic volume (p less than 0.0077). Analysis of patterns of failure showed chronic bladder atony, prostate asymmetry and middle lobe configuration as important factors that could explain the failure of hyperthermia in 3 patients. Toxicity was mild, consisting of bladder spasms, perineal pain, dysuria and hematuria. Hyperthermia-induced pathological changes in prostatic tissues, causing periurethral shrinking and secondary dilatation of the prostatic urethra, are described. The reported clinical results of this phase I study are preliminary due to the short followup. A phase II study to optimize transurethral hyperthermia currently is underway. A phase III study is to be phased in comparing hyperthermia with transurethral resection of the prostate.
Tolerability of high energy transurethral microwave thermotherapy with topical urethral anesthesia: results of a prospective, randomized, single-blinded clinical trial. [2023]We determine the tolerability of high energy transurethral microwave thermotherapy with topical urethral anesthesia alone without supplementary systemic sedoanalgesia.
Warm sitz bath: are there benefits after transurethral resection of the prostate? [2021]We aimed to evaluate the efficacy of warm water sitz baths in patients who have undergone transurethral resection of the prostate (TURP) owing to lower urinary tract symptoms secondary to benign prostatic hyperplasia.