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: March 11, 2014
Last verified: March 2014
  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:


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

Primary Outcome Measures:
  • Lower Urinary Tract Symptoms [ Time Frame: Expected average of 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Expected 2 weeks later ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Pain [ Time Frame: Expected 2 weeks later ] [ Designated as safety issue: Yes ]
  • Drug adverse events [ Time Frame: Expected 2 weeks later ] [ Designated as safety issue: Yes ]

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
Last Updated: March 11, 2014
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on July 31, 2014