The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Disorder of Urinary Stent |
Drug: Placebo Drug: Terazosine Drug: Tolterodine Drug: Tolterodine + Terazosin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 104 |
| Study Start Date: | January 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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:
- 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
Contacts and LocationsPlease 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 |
More Information
Publications:
| Responsible Party: | Urmia University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01530243 History of Changes |
| Other Study ID Numbers: | UUNRC 01 |
| Study First Received: | January 18, 2012 |
| Results First Received: | January 21, 2015 |
| Last Updated: | February 15, 2015 |
| Health Authority: | Iran: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on September 30, 2016