Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03332056 |
| Other study ID # |
44862 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 2013 |
| Est. completion date |
October 2015 |
Study information
| Verified date |
May 2023 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine if preemptive B&O suppository placement will
decrease post-operative pain in patients undergoing ureteral stent placement.
Description:
Purpose: Nephrolithiasis has an incidence of 10-15% in the US with 66% of practicing
urologists placing a ureteral stent after each procedure. Ureteral stents are commonly placed
to prevent or alleviate ureteral obstruction and ureteral stents are not well tolerated with
up to 80% of patients reporting stent discomfort. These symptoms include urinary frequency,
urgency, dysuria and incomplete emptying. Patients also frequently report suprapubic pain,
hematuria and incontinence. Ureteral stents are placed either alone or in conjunction with
other surgeries where ureteral access is obtained.
To date, however, there is no convincing data that altering stent characteristics or the use
of a single drug dramatically improves stent discomfort for patients. Prior studies on oral
therapies including alpha blockers and anti-muscarinics have shown some promise in improving
stent comfort, however, they are typically used after the ureteral stent is placed and the
patient has recovered from anesthesia. Other studies have shown no difference in stent
symptoms in these two classes of drugs.
The Belladonna and Opium (B&O) suppository is a potent anti-muscarinic medication with
narcotic properties. It frequently is used as a second line drug for patients with severe
bladder spasms refractory to first line anti-muscarinic and narcotic medications from an
indwelling Foley catheter or ureteral stent. It has shown efficacy for Foley catheter
discomfort in patients undergoing robotic prostatectomies, but its use in the perioperative
period has not been studied for ureteral stent discomfort.
The purpose of this study is to determine if preemptive B&O suppository placement will
decrease post-operative pain in patients undergoing ureteral stent placement.
Procedures: The study is a randomized double-blind controlled trial comparing the use of a
B&O suppository versus placebo suppository for the preemptive treatment of ureteral stent
discomfort. 70 subjects will be recruited from the outpatient urologic clinic under the care
of a single surgeon with appropriate informed consent. At the time of recruitment, patients
will complete a validated AUA symptom score questionnaire in order to establish baseline
symptom scores and urinary bother. Patients will be randomized into a treatment arm or a
placebo arm. Those randomized to the treatment arm will receive a single B&O suppository,
dose-weight calculated, immediately following patient positioning prior to instrumentation.
Those randomized to the other arm will receive a single placebo suppository. The suppository
will be administered by the circulating operative nurse and the remainder of the surgical
team will be blinded to the study drug. Following treatment and stent placement, all patients
will receive standard post-operative pain management (hydrocodone/acetaminophen, docusate,
and tamsulosin) with usual discharge instructions.
Subject Population: Primary study population is patients who will receive ureteroscopy with
concurrent placement of a ureteral stent. Primary exclusion criteria include age < 18,
neurologic deficits of any kind and non-English speaking patients.
