Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06124066 |
| Other study ID # |
583/UN4.6.4.5.37/PP36/2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
October 30, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Hasanuddin University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Double J stent (ureteral stent) can cause discomfort to patients, generally due to irritation
of the bladder mucosa, especially in the trigone area, smooth muscle spasm, and reflux of
urine into the ureter. Complaints often appear in patients, especially lower urinary tract
symptoms (LUTS), pain in the waist when urinating due to reflux of urine, sexual dysfunction,
and hematuria.
Currently, to assess complaints after ureteral stent placement, the Ureteral Stent Symptom
Questionnaire instrument consists of 6 topics: urinary complaints, pain, general health,
work, sexual problems, and other things.
Interleukin-6 is an important inflammatory cytokine when irritation occurs after ureteral
stent placement. Interleukin 10 is a cytokine with potent anti-inflammatory properties that
plays a central role in limiting the host's immune response to pathogens, thereby preventing
host damage and maintaining normal tissue homeostasis. The profile of these biomarkers has
the potential to determine the correct prognosis and therapy.
Mirabegron is a β3 adrenergic receptor agonist that has a dual antioxidant effect that plays
a key role in the first step of the antimicrobial response and early resolution of
inflammation so that post-stent complaints similar to overactive bladder complaints can be
resolved. Tamsulosin (a selective α1A- and α1D-adrenoceptor antagonist) has a relaxing effect
on the smooth muscle in the prostate, the neck of the bladder, and the distal ureter, thereby
reducing the inflammatory reaction and improving oxidative stress by reducing the formation
of reactive oxidative stress.
Description:
The research design used was experimental with randomized sampling, double-blinded, in men
and women with ureteral stents. The patient signed informed consent regarding blood and urine
sampling, bladder mucosal biopsy, placement and removal of ureteral stents, drug
administration, and side effects of therapy. The history and physical examination of the
patient were recorded including age, height, weight, and body mass index (BMI). Investigation
procedures for urinalysis, routine blood, SGOT/SGPT, urea/creatinine, blood sugar during,
ultrasonography, plain abdominal photos, and CT scan urography were performed on patients
before surgery. The patient's largest stone size is used as a benchmark to record the
patient's stone size.
All patients who underwent routine post-ureterorenoscopy lithotripsy (URSL) ureteral stent
procedures and met the inclusion and exclusion criteria were included in the study
evaluation. The ureteral stent used was 4.7 Fr in size with a length of 24-26 cm, made from
polyurethane used in all patients.
Blood and urine samples will be taken before drug administration begins, and when the
ureteral stent is removed or replaced. Bladder mucosal biopsy was performed in the trigone
vesicae around the contralateral ureteral opening during cystoscopy before ureteral stent
placement, and on the ipsilateral side when the ureteral stent was to be removed or replaced
in the 6th week after ureteral stent placement.
A plain photo of the abdomen or ultrasound is done postoperatively to see the remaining stone
fragments and the position of the ureteral stent. Urethral catheters were removed on the 2nd
postoperative day in all patients before the patients were discharged and given oral
antibiotics (cefadroxil) for 5 days. During the observation phase, the patient was given the
same analgesic (paracetamol 500 mg every 8 hours/24 hours and if needed can be given every 6
hours/24 hours). The total amount of analgesics consumed by the patient will be recorded in
filling out the final questionnaire.
Patients were asked to come to the urology clinic at the hospital for control on the seventh
day. The patient will be given a questionnaire format that will measure the presence or
absence and severity of side effects experienced by the patient for 7 days after ureteral
stent placement.
Patients will be divided into 3 groups of drug administration. The double-blinded method is
used to minimize bias. All medicines were placed in the same 3 boxes, which were held by the
paramedics so that the patients and researchers did not know the allocation of the types of
drugs given. All patients have been informed about the side effects of the drug.
Administration of mirabegron 50 mg/day compared to tamsulosin 0.4 mg and placebo began on the
third day before insertion of the ureteral stent. Completion of the questionnaire began on
the seventh day after ureteral stent insertion, then it was measured every 7 days (7th, 14th,
21st, 28th, 35th, and 42nd day) after ureteral stent insertion. Filling out the questionnaire
can be done by in-person interview at the clinic or by telephone.
