The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Urmia University of Medical Sciences104 enrolled

Overview

The 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Disorder of Urinary Stent

Interventions

PlaceboDRUG

same as tolterodine and terazosin dose

TerazosineDRUG

2 mg BID

TolterodineDRUG

2 mg daily

Tolterodine + Terazosin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling. Exclusion Criteria: 1. Prior history of pelvic surgery 2. Prior history of Transurethral Resection of the either Prostate or Bladder Tumor 3. Benign prostate hyperplasia 4. Recent or recurrent urinary tract infection 5. Chronic medication with beta-blockers or Anti-cholinergic 6. Pregnancy 7. Prostatitis 8. Prostate cancer 9. Bilateral ureteroscopy or ureteral stenting 10. Age \< 18 and \> 55 11. Stone size \> 20 mm 12. Diabetes 13. Bladder Outlet Obstruction

Locations (1)

Imam Khomeini Hospital

Urmia, Azerbaijan-gharbi, Iran

Outcomes

Primary Outcomes

Lower Urinary Tract Symptoms (LUTS)

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.

Time frame: Expected average of 2 weeks

Secondary Outcomes

Quality of Life

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.

Time frame: Expected 2 weeks later

Data from ClinicalTrials.gov

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