The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase One of Study on Urinary Stent Complications and Treatment

Conditions
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Disorder of Urinary Stent

Intervention / Treatment
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* Drug: Placebo
* Drug: Terazosine
* Drug: Tolterodine
* Drug: Tolterodine + Terazosin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* same as tolterodine and terazosin dose<br>* Other names: Group 1;|
| Active Comparator: Terazosin<br> | Drug: Terazosine<br>* 2 mg BID<br>* Other names: Group 2;|
| Active Comparator: Tolterodine<br> | Drug: Tolterodine<br>* 2 mg daily<br>* Other names: Group 3;|
| Active Comparator: Tolterodine + Terazosin<br> | Drug: Tolterodine + Terazosin<br>* 2mg daily and 2mg BID<br>* Other names: Group 4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Expected 2 weeks later |