Title
The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms
Phase One of Study on Urinary Stent Complications and Treatment
Phase
Phase 2/Phase 3Lead Sponsor
Urmia University of Medical SciencesStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Disorder of Urinary StentIntervention/Treatment
terazosin tolterodine ...Study Participants
104The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.
Ureteral stent (US) has been as essential tool in the urologist's surgeries and is useful instruments that its indications increase due to new stent technologies and improvement of patient's comfort.
US associated with discomfort complications that include lower urinary tract symptoms (LUTS) as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic's pain, incontinence, hematuria, movement of stent, infection and encrustation of stent. US related symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate the effect of terazosin and tolterodine lonely and together in comparison of placebo on US related symptoms.
The investigators study will be done prospectively. The patients who underwent indwelling Double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice 3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All of the patients receive prophylactic antibiotic and on demand analgesic. After entrance to study, they fulfill the International Prostatic Symptoms Score (IPSS) and Visual Analog Scale (VAS) on the before indwelling US, two weeks after indwelling US and US removal time, then the investigators will evaluate the drug's effect on US related symptoms.
same as tolterodine and terazosin dose
2 mg BID
2 mg daily
2mg daily and 2mg BID
Inclusion Criteria: If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling. Exclusion Criteria: Prior history of pelvic surgery Prior history of Transurethral Resection of the either Prostate or Bladder Tumor Benign prostate hyperplasia Recent or recurrent urinary tract infection Chronic medication with beta-blockers or Anti-cholinergic Pregnancy Prostatitis Prostate cancer Bilateral ureteroscopy or ureteral stenting Age < 18 and > 55 Stone size > 20 mm Diabetes Bladder Outlet Obstruction
| Event Type | Organ System | Event Term | Placebo | Terazosin | Tolterodine | Tolterodine + Terazosin |
|---|
LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.
The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life.
The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain.
