The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Disorder of Urinary Stent	Drug: Placebo; Drug: Terazosine; Drug: Tolterodine; Drug: Tolterodine + Terazosin	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

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Study Type :	Interventional (Clinical Trial)
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 :	January 2012
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	September 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Other Outcome Measures:

1. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Responsible Party:	Urmia University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01530243 History of Changes
Other Study ID Numbers:	UUNRC 01
First Posted:	February 9, 2012
Results First Posted:	March 2, 2015
Last Update Posted:	March 2, 2015
Last Verified:	February 2015

Additional relevant MeSH terms:

Tolterodine Tartrate; Terazosin; Prazosin; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action	Physiological Effects of Drugs; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Antihypertensive Agents