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Efficacy of Tadalafil on Lower Urinary tract Symptoms of patients with ureteral stents

Comparison of effectiveness of Tadalafil versus placebo on lower urinary tract symptoms in male patients with ureteral stent, A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013113015597N1
Enrollment
80
Registered
2014-02-19
Start date
2013-12-06
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

LUTS associated with ureteral stents. hematuria, dysuria, pain , urgency , frequency, incontinance

Interventions

Intervention 1: In the intervention group, tadalafil tablet (Chemidarou company) 10 mg once daily is given for 4 weeks by oral route. Intervention 2: In the control group, a placebo tablet (same shape
Treatment - Drugs
Placebo
In the intervention group, tadalafil tablet (Chemidarou company) 10 mg once daily is given for 4 weeks by oral route.
In the control group, a placebo tablet (same shape, size and color of tadalafil which was made from starch by Pharmacy faculty of Tabriz University of Medical Sciences) is given for 4 weeks by oral ro

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Male patients (+15 years) that underwent unilateral ureteral stenting. Exclusion criteria: Patient's refusal of study; high blood pressure; history of heart disease; history of respiratory disease; history of stroke; hypotension (systolic blood pressure less than 90 mmHg); hepatic and renal failure; history of retinitis pigmentosa; severe headache; consumption of nitrate drugs and a positive urine culture

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Urinary symptoms (urgency; frequency; nocturia; dysuria; hematuria; incomplete emptying) in patients with ureteral stents. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).;Abdominal pain, flank pain, inguinal and genital pain and pain severity and its association with physical activity, rest, voiding,… in patients with ureteral stent. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).;General health in patient with ureteral stent. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).;Sexual matters in patients with ureteral stent. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).;Work performance in patients with ureteral stent. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).

Secondary

MeasureTime frame
Cardiovascular side effects. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Questionnaire.;Musculoskeletal side effects. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Abbas Jabbari

Urology Department, Tabriz University of Medical Sciences

abbasjabbari@yahoo.com+98 41 1335 7328

Outcome results

None listed

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