NCT01530243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 2, 2015

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

7 months

First QC Date

January 18, 2012

Results QC Date

January 21, 2015

Last Update Submit

February 15, 2015

Conditions

Disorder of Urinary Stent

Outcome Measures

Primary Outcomes (1)

  • Lower Urinary Tract Symptoms (LUTS)

    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.

    Expected average of 2 weeks

Secondary Outcomes (1)

  • Quality of Life

    Expected 2 weeks later

Other Outcomes (1)

  • Pain

    Expected 2 weeks later

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Terazosin

ACTIVE COMPARATOR
Drug: Terazosine

Tolterodine

ACTIVE COMPARATOR
Drug: Tolterodine

Tolterodine + Terazosin

ACTIVE COMPARATOR
Drug: Tolterodine + Terazosin

Interventions

PlaceboDRUG

same as tolterodine and terazosin dose

Also known as: Group 1
Placebo
TerazosineDRUG

2 mg BID

Also known as: Group 2
Terazosin
TolterodineDRUG

2 mg daily

Also known as: Group 3
Tolterodine
Tolterodine + TerazosinDRUG

2mg daily and 2mg BID

Also known as: Group 4
Tolterodine + Terazosin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomeini Hospital

Urmia, Azerbaijan-gharbi, Iran

Location

Related Publications (1)

  • Tehranchi A, Rezaei Y, Khalkhali H, Rezaei M. Effects of terazosin and tolterodine on ureteral stent related symptoms: a double-blind placebo-controlled randomized clinical trial. Int Braz J Urol. 2013 Nov-Dec;39(6):832-40. doi: 10.1590/S1677-5538.IBJU.2013.06.09.

    PMID: 24456787BACKGROUND

MeSH Terms

Interventions

TerazosinTolterodine Tartrate

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Limitations and Caveats

Applying stents with the same size and length

Results Point of Contact

Title
Yousef Rezaei
Organization
Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences
yousefrezaei1986@gmail.com
+989126231864

Study Officials

  • Ali Tehranchi, Urologist

    Urology department

    STUDY CHAIR

  • Yousef Rezaei, M.D

    Urmia University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

February 9, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

March 2, 2015

Results First Posted

March 2, 2015

Record last verified: 2015-02

Locations

IR(1)