The effect of tadalafil compared to tamsulosin and placebo on the symptoms of double-J stent insertion in men with ureter stones

The study of the effect of tadalafil in comparison with tamsulosin and placebo on the symptoms of double-J stent insertion in ureteral following by transureteral ureteroscopy and lithotripsy in men with ureteral stones

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201702261853N13

Enrollment

120

Registered

2017-08-14

Start date

2015-09-11

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Lower urinary tract symptoms. Condition 2: Pain in the flank and suprapubic areas. Condition 3: Sexual function. Calculus of lower urinary tract Other and unspecified abdominal pain Unspecified sexual dysfunction, not caused by organic disorder or disease

Interventions

Intervention 1: Intervention group: Tadalafil 5 mg tablet, made in Iran, one daily dose, for 4 weeks. Intervention 2: Intervention group: Tamsulosin 0.4 mg tablet, made in Iran, one daily dose, for 4

Treatment - Drugs

Placebo

Intervention group: Tadalafil 5 mg tablet, made in Iran, one daily dose, for 4 weeks

Intervention group: Tamsulosin 0.4 mg tablet, made in Iran, one daily dose, for 4 weeks

Control group: Placebo tablet, made in Iran, one daily dose, for 4 weeks

Eligibility

Sex/Gender

Male

Age

18 Years to 139 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: male with age = 18 years; negative U/C; unilateral DJ-stent insertion; testimonial endorsement Exclusion criteria: any underlying disease specially cardiovascular nephrogenic; allergic; other urologic disease; acute urinary retention (AUR); diabetes mellitus (DM); urinary tract malignancy; chronic pelvic pain syndrome (CPPS); Lower Urinary Tract Symptoms (LUTS); bilateral stent; PSA>10 ng/ml or PSA=4-10 ng/ml with positive prostate biopsy for malignancy; recent Extracorporeal shock wave lithotripsy (ESWL); stent malposition; neurogenic bladder; kidney transplant; radiation or chemotherapy; long term treatment with a-blockers, anticholinergic, analgesic, Selective serotonin reuptake inhibitors (SSRIs), diuretics, calcium channel blockers (CCB), lithium; opium addiction; all conditions that urologist prefers to exclude patient.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain in the flank, suprapubic and in voiding time. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By the standard questionnaire of pain measurement (VAS score).;Sexual function. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By USSQ standard questionnaire.;Symptoms related to lower urinary tract after stent inserting (including all obstructive and irritative symptoms). Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By USSQ standard questionnaire and IPSS standard questionnaire.;Dysuria. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By USSQ standard questionnaire.;Hematuria. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By USSQ standard questionnaire.	—

Measure

Time frame

Pain in the flank, suprapubic and in voiding time. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By the standard questionnaire of pain measurement (VAS score).;Sexual function. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By USSQ standard questionnaire.;Symptoms related to lower urinary tract after stent inserting (including all obstructive and irritative symptoms). Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By USSQ standard questionnaire and IPSS standard questionnaire.;Dysuria. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By USSQ standard questionnaire.;Hematuria. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By USSQ standard questionnaire.

—

Secondary

Measure	Time frame
Need for additional antibiotic intake. Timepoint: 2 and 4 weeks after intervention. Method of measurement: By USSQ Standard Questionnaire.;Impact on the quality of life and work. Timepoint: 2 and 4 weeks after intervention. Method of measurement: By USSQ Standard Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Keivan Gholamjani Moghaddam

Urology Research Center, Guilan University of Medical Sciences

urc1384@yahoo.com+98 13 3352 5259

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026