Actively Recruiting
Safety and Efficacy of Tamsulosin 0.4 mg Plus Tadalafil 5 mg Versus 2.5 mg for Ureteric Stent Related Symptoms
Led by Ain Shams University · Updated on 2026-05-01
140
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ureteral stenting is a common urological procedure used to relieve blockage and aid urinary drainage, but it often causes bothersome symptoms such as pain, frequent urination, urgency, and sexual discomfort, which can reduce quality of life. Researchers are studying the effects of combining two drugs, Tamsulosin and Tadalafil, at different doses to see how well they reduce these stent-related symptoms in patients who have had stones removed endoscopically and have a ureteral stent in place. The trial compares two groups of about 70 patients each. One group will take Tamsulosin 0.4 mg with a low dose of Tadalafil (2.5 mg) daily, while the other group takes Tamsulosin 0.4 mg with a standard Tadalafil dose (5 mg) daily. The study aims to find out if the lower dose of Tadalafil combined with Tamsulosin is as effective in easing symptoms caused by the ureteral stent as the higher dose combination. Participants will be monitored over 4 weeks to evaluate stent-related symptoms. The study includes regular assessments of urinary symptoms and pain related to the stent. The research team will carefully review the safety and effectiveness of both treatment combinations during this period. The total participation time aligns with the 4-week symptom evaluation, and researchers will monitor patients for any side effects or changes in symptoms throughout the study.
CONDITIONS
Brief Title
Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years of age
- Presence of a double-J (DJ) stent (polyurethane) after endoscopic stone removal
You will not qualify if you...
- Patients younger than 18 years of age
- History of prostate or bladder surgery
- Prior lower urinary tract procedures
- Diagnosis of cancer
- Neurological conditions
- History of pelvic radiation
- Diabetes
- Kidney dysfunction (acute or chronic)
- Solitary kidney
- Congenital urinary anomalies
- Current use of alpha-blockers, beta-blockers, calcium channel blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, anticholinergics, or nitrates
- Cardiac issues
- Residual stone fragments after surgery
- Multiple or bilateral ureteral stones
- Long-term or bilateral stents requiring frequent changes
- Interstitial cystitis
- Chronic cystitis
- Prostatitis
- Pregnant women
- Breastfeeding women
- Patients unavailable for follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants take daily tablets of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg or 5 mg to relieve stent-related symptoms.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
Ain Shams University Hospital
Cairo, Abbasia, Egypt
Actively Recruiting
Research Team
A
Ahmed Amr Mohammed Mounier, MSc
W
Waleed Mousa, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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