The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

February 15, 2015 updated by: Urmia University of Medical Sciences

Phase One of Study on Urinary Stent Complications and Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
same as tolterodine and terazosin dose
Other Names:
  • Group 1
Active Comparator: Tolterodine
Drug: Tolterodine
2 mg daily
Other Names:
  • Group 3
Active Comparator: Terazosin
Drug: Terazosine
2 mg BID
Other Names:
  • Group 2
Active Comparator: Tolterodine + Terazosin
Drug: Tolterodine + Terazosin
2mg daily and 2mg BID
Other Names:
  • Group 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Expected 2 weeks later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Expected 2 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urmia University of Medical Sciences

Investigators

  • Study Chair: Ali Tehranchi, Urologist, Urology Department
  • Principal Investigator: Yousef Rezaei, M.D, Urmia University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

February 6, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 15, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UUNRC 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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