The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms
|Disorder of Urinary Stent||Drug: Placebo Drug: Terazosine Drug: Tolterodine Drug: Tolterodine + Terazosin||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase One of Study on Urinary Stent Complications and Treatment|
- 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.
- 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.
- 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.
|Study Start Date:||January 2012|
|Study Completion Date:||September 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
same as tolterodine and terazosin dose
Other Name: Group 1
|Active Comparator: Terazosin||
2 mg BID
Other Name: Group 2
|Active Comparator: Tolterodine||
2 mg daily
Other Name: Group 3
|Active Comparator: Tolterodine + Terazosin||
Drug: Tolterodine + Terazosin
2mg daily and 2mg BID
Other Name: Group 4
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530243
|Iran, Islamic Republic of|
|Imam Khomeini Hospital|
|Urmia, Azerbaijan-gharbi, Iran, Islamic Republic of|
|Study Chair:||Ali Tehranchi, Urologist||Urology department|
|Principal Investigator:||Yousef Rezaei, M.D||Urmia University of Medical Sciences|