The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

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.

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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.

Conditions

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Disorder of Urinary Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

same as tolterodine and terazosin dose

Terazosin

Group Type ACTIVE_COMPARATOR

Terazosine

Intervention Type DRUG

2 mg BID

Tolterodine

Group Type ACTIVE_COMPARATOR

Tolterodine

Intervention Type DRUG

2 mg daily

Tolterodine + Terazosin

Group Type ACTIVE_COMPARATOR

Tolterodine + Terazosin

Intervention Type DRUG

2mg daily and 2mg BID

Interventions

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Placebo

same as tolterodine and terazosin dose

Intervention Type DRUG

Terazosine

2 mg BID

Intervention Type DRUG

Tolterodine

2 mg daily

Intervention Type DRUG

Tolterodine + Terazosin

2mg daily and 2mg BID

Intervention Type DRUG

Other Intervention Names

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Group 1 Group 2 Group 3 Group 4

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No