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The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Urmia University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01530243
First received: January 18, 2012
Last updated: February 15, 2015
Last verified: February 2015
History of Changes
  Purpose

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 Intervention Phase
Disorder of Urinary Stent
 Drug: Placebo
Drug: Terazosine
Drug: Tolterodine
Drug: Tolterodine + Terazosin
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase One of Study on Urinary Stent Complications and Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Urmia University of Medical Sciences:

Primary Outcome Measures:
  • Lower Urinary Tract Symptoms (LUTS) [ Time Frame: Expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Quality of Life [ Time Frame: Expected 2 weeks later ] [ Designated as safety issue: Yes ]
    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:
  • Pain [ Time Frame: Expected 2 weeks later ] [ Designated as safety issue: Yes ]
    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.
Enrollment: 104
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530243

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

Publications:

Responsible Party: Urmia University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01530243     History of Changes
Other Study ID Numbers: UUNRC 01
Study First Received: January 18, 2012
Results First Received: January 21, 2015
Last Updated: February 15, 2015
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Phenylpropanolamine
Terazosin
Tolterodine
Adrenergic Agents
Adrenergic Agonists
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Agonists
Adrenergic alpha-Antagonists
Anti-Obesity Agents
Appetite Depressants
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
 Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Urological Agents
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on March 03, 2015