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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Terazosin | Active Comparator |
| |
| Tolterodine | Active Comparator |
| |
| Tolterodine + Terazosin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | same as tolterodine and terazosin dose |
|
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 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. | Expected 2 weeks later |
Inclusion Criteria:
If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Tehranchi, Urologist | Urology department | Study Chair |
| Yousef Rezaei, M.D | Urmia University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam Khomeini Hospital | Urmia | Azerbaijan-gharbi | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24456787 | Background | Tehranchi A, Rezaei Y, Khalkhali H, Rezaei M. Effects of terazosin and tolterodine on ureteral stent related symptoms: a double-blind placebo-controlled randomized clinical trial. Int Braz J Urol. 2013 Nov-Dec;39(6):832-40. doi: 10.1590/S1677-5538.IBJU.2013.06.09. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: same as tolterodine and terazosin dose |
| FG001 | Terazosin | Terazosin: 2 mg BID |
| FG002 | Tolterodine | Tolterodine: 2 mg daily |
| FG003 | Tolterodine + Terazosin | Tolterodine + Terazosin: 2mg daily and 2mg BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: same as tolterodine and terazosin dose |
| BG001 | Terazosin | Terazosine: 2 mg BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes. | Posted | Mean | Standard Deviation | units on a scale | Expected average of 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: same as tolterodine and terazosin dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
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Applying stents with the same size and length
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yousef Rezaei | Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences | +989126231864 | yousefrezaei1986@gmail.com |
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| ID | Term |
|---|---|
| C041226 | Terazosin |
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Terazosine | Drug | 2 mg BID |
|
|
| Tolterodine | Drug | 2 mg daily |
|
|
| Tolterodine + Terazosin | Drug | 2mg daily and 2mg BID |
|
|
| BG002 |
| Tolterodine |
Tolterodine: 2 mg daily |
| BG003 | Tolterodine + Terazosin | Tolterodine + Terazosin: 2mg daily and 2mg BID |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Terazosine: 2 mg BID |
| OG002 | Tolterodine | Tolterodine: 2 mg daily |
| OG003 | Tolterodine + Terazosin | Tolterodine + Terazosin: 2mg daily and 2mg BID |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Expected 2 weeks later |
|
|
|
| Other Pre-specified | Pain | 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. | Posted | Mean | Standard Deviation | units on a scale | Expected 2 weeks later |
|
|
|
| 2 |
| 24 |
| 0 |
| 24 |
| EG001 | Terazosin | Terazosin: 2 mg BID | 4 | 23 | 0 | 23 |
| EG002 | Tolterodine | Tolterodine: 2 mg daily | 1 | 23 | 0 | 23 |
| EG003 | Tolterodine + Terazosin | Tolterodine + Terazosin: 2mg daily and 2mg BID | 6 | 24 | 0 | 24 |
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |