The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Disorder of Urinary Stent Clinical Trial

Official title:

Phase One of Study on Urinary Stent Complications and Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530243
• Other study ID #: UUNRC 01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 18, 2012
• Last updated: February 15, 2015
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: February 2015
• Source: Urmia University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Urinary Stent

Intervention

Drug:
• Placebo
same as tolterodine and terazosin dose
• Terazosine
2 mg BID
• Tolterodine
2 mg daily
• Tolterodine + Terazosin
2mg daily and 2mg BID

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital	Urmia	Azerbaijan-gharbi

Sponsors (1)

Lead Sponsor	Collaborator
Urmia University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Expected 2 weeks later	Yes
Primary	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.	Expected average of 2 weeks	Yes
Secondary	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.	Expected 2 weeks later	Yes