Clinical trial NCT01530243: The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms
Official title: Phase One of Study on Urinary Stent Complications and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Disorder of Urinary Stent
Lead sponsor: Urmia University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Lower Urinary Tract Symptoms (LUTS)
timeFrame: Expected average of 2 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: Expected 2 weeks later
Other outcomes:
measure: Pain
timeFrame: Expected 2 weeks later
Locations:
city: Urmia
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital
state: Azerbaijan-gharbi
Study officials:
affiliation: Urology department
name: Ali Tehranchi, Urologist
role: STUDY_CHAIR
affiliation: Urmia University of Medical Sciences
name: Yousef Rezaei, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.