The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

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.

• Placebo (Drug), also known as Group 1: same as tolterodine and terazosin dose
• Terazosine (Drug), also known as Group 2: 2 mg BID
• Tolterodine (Drug), also known as Group 3: 2 mg daily
• Tolterodine + Terazosin (Drug), also known as Group 4: 2mg daily and 2mg BID

Primary outcomes

• Lower Urinary Tract Symptoms (LUTS) [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.

Secondary outcomes

• Quality of Life [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.

Other outcomes

• Pain [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.

Sex: All, ages: 18 Years to 55 Years

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

Participant flow

Outcome results

• Lower Urinary Tract Symptoms (LUTS) (Primary), Mean, units on a scale: Placebo 11.12 +/- 7.84; Terazosin 4.39 +/- 6.03; Tolterodine 7.21 +/- 6.57; Tolterodine + Terazosin 5.58 +/- 4.82
• Quality of Life (Secondary), Mean, units on a scale: Placebo 3.37 +/- 2.16; Terazosin 2 +/- 2.25; Tolterodine 2.30 +/- 1.89; Tolterodine + Terazosin 0.95 +/- 1.12
• Pain (Other pre specified), Mean, units on a scale: Placebo 4.16 +/- 3.59; Terazosin 3.21 +/- 4.14; Tolterodine 1.34 +/- 2.60; Tolterodine + Terazosin 1.37 +/- 2.56

Adverse events

Serious adverse events by term

Limitations and caveats: Applying stents with the same size and length

• 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. PMID 24456787

• Ali Tehranchi, Urologist, Study chair, Urology department
• Yousef Rezaei, M.D, Principal investigator, Urmia University of Medical Sciences