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Completed

NCT Number: NCT01530243

The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

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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Key information

Conditions

Disorder of Urinary Stent

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Imam Khomeini Hospital

Urmia, Azerbaijan-gharbi, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

same as tolterodine and terazosin dose

Other names: Group 1

Terazosine

Drug

2 mg BID

Other names: Group 2

tolterodine

Drug

2 mg daily

Other names: Group 3

Tolterodine + Terazosin

Drug

2mg daily and 2mg BID

Other names: Group 4

Primary outcomes

  1. Lower Urinary Tract Symptoms (LUTS)

    Time frame: Expected average of 2 weeks

    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.

Secondary outcomes

  1. Quality of Life

    Time frame: Expected 2 weeks later

    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.

Other outcomes

  1. Pain

    Time frame: Expected 2 weeks later

    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.

Sponsors and collaborators

Lead sponsor

Urmia University of Medical Sciences

Other

Registry information

Official study title

Phase One of Study on Urinary Stent Complications and Treatment

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 9, 2012
Registry last updated
Mar 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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