CompletedNCT01530243Updated Mar 2, 2015Results posted

The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

A Phase 2/3 interventional study of Placebo and Terazosine in Disorder of Urinary Stent, sponsored by Urmia University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-03-02.

Sponsored by Urmia University of Medical Sciences · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 104
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Disorder of Urinary Stent

In context

Lead sponsor

Urmia University of Medical Sciences is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: 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

Exclusion Criteria:

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 104 participants (actual)

Study arms

Placebo comparator
Placebo
Drug: Placebo
Active comparator
Terazosin
Drug: Terazosine
Active comparator
Tolterodine
Drug: Tolterodine
Active comparator
Tolterodine + Terazosin
Drug: Tolterodine + Terazosin

Interventions

DrugPlacebo
same as tolterodine and terazosin dose
Also known as: Group 1
DrugTerazosine
2 mg BID
Also known as: Group 2
DrugTolterodine
2 mg daily
Also known as: Group 3
DrugTolterodine + Terazosin
2mg daily and 2mg BID
Also known as: Group 4

What researchers measure

Primary outcomes

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.
Time frame: Expected average of 2 weeks

Secondary outcomes

Quality of Life
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

Other outcomes

Pain
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

Results

Posted Mar 2, 2015

Limitations and caveats

Applying stents with the same size and length

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Terazosin	Tolterodine	Tolterodine + Terazosin
Started	26	26	26	26
Completed	24	23	23	24
Not completed	2	3	3	2

Outcome measures

PrimaryLower 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.

Time frame:: Expected average of 2 weeks
Reported as:: Mean · units on a scale

Lower Urinary Tract Symptoms (LUTS)
units on a scale	Placebo	Terazosin	Tolterodine	Tolterodine + Terazosin
Lower Urinary Tract Symptoms (LUTS)	11.12 ± 7.84	4.39 ± 6.03	7.21 ± 6.57	5.58 ± 4.82

SecondaryQuality of Life

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
Reported as:: Mean · units on a scale

Quality of Life
units on a scale	Placebo	Terazosin	Tolterodine	Tolterodine + Terazosin
Quality of Life	3.37 ± 2.16	2 ± 2.25	2.30 ± 1.89	0.95 ± 1.12

Other pre-specifiedPain

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
Reported as:: Mean · units on a scale

Pain
units on a scale	Placebo	Terazosin	Tolterodine	Tolterodine + Terazosin
Pain	4.16 ± 3.59	3.21 ± 4.14	1.34 ± 2.60	1.37 ± 2.56

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	2/24 (8.3%)	0/24 (0%)
Terazosin	—	4/23 (17.4%)	0/23 (0%)
Tolterodine	—	1/23 (4.3%)	0/23 (0%)
Tolterodine + Terazosin	—	6/24 (25%)	0/24 (0%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Terazosin	Tolterodine	Tolterodine + Terazosin
Orthostatic hypotensionVascular disorders	2/24	4/23	1/23	6/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	Terazosin	Tolterodine	Tolterodine + Terazosin	Total
Mean	33.37 ± 9.58	38.35 ± 9.23	37.04 ± 9.04	35.75 ± 9.38	36.53 ± 9.53

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Terazosin	Tolterodine	Tolterodine + Terazosin	Total
Female	3	7	4	5	19
Male	21	16	19	19	75

Region of Enrollment
Region of Enrollment(participants)	Placebo	Terazosin	Tolterodine	Tolterodine + Terazosin	Total
Iran, Islamic Republic of	24	23	23	24	94

Study locations

1 site

Imam Khomeini Hospital
Urmia, Azerbaijan-gharbi, Iran, Islamic Republic of

References and documents

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. PubMed 24456787 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01530243
Lead sponsor: Urmia University of Medical Sciences
Responsible party: Sponsor
First posted: Feb 9, 2012
Start date: Jan 2012
Primary completion: Aug 2012
Completion: Sep 2012
Results posted: Mar 2, 2015
Last update: Mar 2, 2015

Study contacts

Ali Tehranchi, Urologist

study chair · Urology department

Yousef Rezaei, M.D

principal investigator · Urmia University of Medical Sciences

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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