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The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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