The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Urmia University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Disorder of Urinary Stent

Treatments: Drug: Placebo; Drug: Tolterodine; Drug: Terazosine; Drug: Tolterodine + Terazosin

Study type: Interventional

Funder types: Other

Identifiers

NCT01530243

UUNRC 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

104 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Terazosin

Active Comparator group

Treatment:

Drug: Terazosine

Tolterodine

Active Comparator group

Treatment:

Drug: Tolterodine

Tolterodine + Terazosin

Active Comparator group

Treatment:

Drug: Tolterodine + Terazosin