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The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

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ClinicalTrials.gov Identifier: NCT01530243
Recruitment Status : Completed
First Posted : February 9, 2012
Results First Posted : March 2, 2015
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
Urmia University of Medical Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Disorder of Urinary Stent Drug: Placebo Drug: Terazosine Drug: Tolterodine Drug: Tolterodine + Terazosin Phase 2 Phase 3

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase One of Study on Urinary Stent Complications and Treatment
Study Start Date : January 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
same as tolterodine and terazosin dose
Other Name: Group 1
Active Comparator: Terazosin Drug: Terazosine
2 mg BID
Other Name: Group 2
Active Comparator: Tolterodine Drug: Tolterodine
2 mg daily
Other Name: Group 3
Active Comparator: Tolterodine + Terazosin Drug: Tolterodine + Terazosin
2mg daily and 2mg BID
Other Name: Group 4


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530243


Locations
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Iran, Islamic Republic of
Imam Khomeini Hospital
Urmia, Azerbaijan-gharbi, Iran, Islamic Republic of
Sponsors and Collaborators
Urmia University of Medical Sciences
Investigators
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Study Chair: Ali Tehranchi, Urologist Urology department
Principal Investigator: Yousef Rezaei, M.D Urmia University of Medical Sciences
More Information
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Publications:

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Responsible Party: Urmia University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01530243    
Other Study ID Numbers: UUNRC 01
First Posted: February 9, 2012    Key Record Dates
Results First Posted: March 2, 2015
Last Update Posted: March 2, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Tolterodine Tartrate
Terazosin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Urological Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents