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The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Sponsor
Urmia University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01530243
Collaborator
(none)
104
Enrollment
1
Location
4
Arms
8
Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Jan 1, 2012
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebo
same as tolterodine and terazosin dose
Other Names:
  • Group 1

    		•
    Active Comparator: Terazosin

    Drug: Terazosine
    2 mg BID
    Other Names:
  • Group 2

    		•
    Active Comparator: Tolterodine

    Drug: Tolterodine
    2 mg daily
    Other Names:
  • Group 3

    		•
    Active Comparator: Tolterodine + Terazosin

    Drug: Tolterodine + Terazosin
    2mg daily and 2mg BID
    Other Names:
  • Group 4

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lower Urinary Tract Symptoms (LUTS) [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Urmia University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01530243
    Other Study ID Numbers:
    • UUNRC 01
    First Posted:
    Feb 9, 2012
    Last Update Posted:
    Mar 2, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Tolterodine Tartrate
    Terazosin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Placebo Terazosin Tolterodine Tolterodine + Terazosin
    Arm/Group Description Placebo: same as tolterodine and terazosin dose Terazosin: 2 mg BID Tolterodine: 2 mg daily Tolterodine + Terazosin: 2mg daily and 2mg BID
    Period Title: Overall Study
    STARTED 26 26 26 26
    COMPLETED 24 23 23 24
    NOT COMPLETED 2 3 3 2

    Baseline Characteristics

    Arm/Group Title Placebo Terazosin Tolterodine Tolterodine + Terazosin Total
    Arm/Group Description Placebo: same as tolterodine and terazosin dose Terazosine: 2 mg BID Tolterodine: 2 mg daily Tolterodine + Terazosin: 2mg daily and 2mg BID Total of all reporting groups
    Overall Participants 24 23 23 24 94
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    33.37
    (9.58)
    38.35
    (9.23)
    37.04
    (9.04)
    35.75
    (9.38)
    36.53
    (9.53)
    Sex: Female, Male (Count of Participants)
    Female
    3
    12.5%
    7
    30.4%
    4
    17.4%
    5
    20.8%
    19
    20.2%
    Male
    21
    87.5%
    16
    69.6%
    19
    82.6%
    19
    79.2%
    75
    79.8%
    Region of Enrollment (participants) [Number]
    Iran, Islamic Republic of
    24
    100%
    23
    100%
    23
    100%
    24
    100%
    94
    100%

    Outcome Measures

    1. Primary Outcome
    Title Lower Urinary Tract Symptoms (LUTS)
    Description 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.
    Time Frame Expected average of 2 weeks

    Outcome Measure Data

    Analysis Population Description
    The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.
    Arm/Group Title Placebo Terazosin Tolterodine Tolterodine + Terazosin
    Arm/Group Description Placebo: same as tolterodine and terazosin dose Terazosine: 2 mg BID Tolterodine: 2 mg daily Tolterodine + Terazosin: 2mg daily and 2mg BID
    Measure Participants 24 23 23 24
    Mean (Standard Deviation) [units on a scale]
    11.12
    (7.84)
    4.39
    (6.03)
    7.21
    (6.57)
    5.58
    (4.82)
    2. Secondary Outcome
    Title Quality of Life
    Description 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.
    Time Frame Expected 2 weeks later

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Terazosin Tolterodine Tolterodine + Terazosin
    Arm/Group Description Placebo: same as tolterodine and terazosin dose Terazosine: 2 mg BID Tolterodine: 2 mg daily Tolterodine + Terazosin: 2mg daily and 2mg BID
    Measure Participants 24 23 23 24
    Mean (Standard Deviation) [units on a scale]
    3.37
    (2.16)
    2
    (2.25)
    2.30
    (1.89)
    0.95
    (1.12)
    3. Other Pre-specified Outcome
    Title Pain
    Description 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.
    Time Frame Expected 2 weeks later

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Terazosin Tolterodine Tolterodine + Terazosin
    Arm/Group Description Placebo: same as tolterodine and terazosin dose Terazosin: 2 mg BID Tolterodine: 2 mg daily Tolterodine + Terazosin: 2mg daily and 2mg BID
    Measure Participants 24 23 23 24
    Mean (Standard Deviation) [units on a scale]
    4.16
    (3.59)
    3.21
    (4.14)
    1.34
    (2.60)
    1.37
    (2.56)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Placebo Terazosin Tolterodine Tolterodine + Terazosin
    Arm/Group Description Placebo: same as tolterodine and terazosin dose Terazosin: 2 mg BID Tolterodine: 2 mg daily Tolterodine + Terazosin: 2mg daily and 2mg BID
    All Cause Mortality
    Placebo Terazosin Tolterodine Tolterodine + Terazosin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Terazosin Tolterodine Tolterodine + Terazosin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/24 (8.3%) 4/23 (17.4%) 1/23 (4.3%) 6/24 (25%)
    Vascular disorders
    Orthostatic hypotension 2/24 (8.3%) 2 4/23 (17.4%) 4 1/23 (4.3%) 1 6/24 (25%) 6
    Other (Not Including Serious) Adverse Events
    Placebo Terazosin Tolterodine Tolterodine + Terazosin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/23 (0%) 0/23 (0%) 0/24 (0%)

    Limitations/Caveats

    Applying stents with the same size and length

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Yousef Rezaei
    Organization Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences
    Phone +989126231864
    Email yousefrezaei1986@gmail.com
    Responsible Party:
    Urmia University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01530243
    Other Study ID Numbers:
    • UUNRC 01
    First Posted:
    Feb 9, 2012
    Last Update Posted:
    Mar 2, 2015
    Last Verified:
    Feb 1, 2015