Tamsulosin 0.4 mg with Tadalafil 5 mg versus 2.5 mg to reduce symptoms from ureteral stents
Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms
This will test whether adding Tadalafil at 5 mg or 2.5 mg to Tamsulosin 0.4 mg better reduces stent-related symptoms for adults with a double-J ureteral stent after stone removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 71 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cairo, Abbasia) |
| Trial ID | NCT07562282 on ClinicalTrials.gov |
What this trial studies
Adults with polyurethane double-J stents placed after endoscopic stone removal receive Tamsulosin 0.4 mg plus either Tadalafil 5 mg or 2.5 mg and are followed for stent-related symptoms such as flank pain, urinary frequency, urgency, dysuria, hematuria, and sexual discomfort. The trial compares symptom burden and safety between the two tadalafil doses when used in combination with tamsulosin. Major exclusions include prior prostate or bladder surgery, significant cardiac disease, diabetes, kidney dysfunction, solitary kidney, neurological or oncologic conditions, recent pelvic radiation, or use of interacting medications. Outcomes focus on patient-reported symptom scores and adverse events during the stent dwell time.
Who should consider this trial
Good fit: Adults over 18 years old who have a polyurethane double-J stent placed after endoscopic kidney stone removal and who do not meet any exclusion criteria are appropriate candidates.
Not a fit: Patients with diabetes, renal dysfunction, solitary kidney, prior pelvic or lower urinary tract surgery, active cancer, significant cardiac or neurological disease, recent pelvic radiation, or those taking excluded medications are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this combination could reduce stent-related symptoms and improve quality of life, possibly with fewer side effects or lower cost if the 2.5 mg dose proves effective.
How similar studies have performed: Previous studies suggest alpha-blockers and PDE5 inhibitors can reduce stent-related symptoms, but the combination of tamsulosin with a half-dose (2.5 mg) tadalafil has not been well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal. Exclusion Criteria: * Patients younger than 18 years of age were excluded. * Patients with a history of prostate or bladder surgery were excluded. * Patients with prior lower urinary tract procedures were excluded. * Patients with cancer were excluded. * Patients with neurological conditions were excluded. * Patients with a history of pelvic radiation were excluded. * Patients with diabetes were excluded. * Patients with kidney dysfunction (acute or chronic) were excluded. * Patients with a solitary kidney were excluded. * Patients with congenital urinary anomalies were excluded. * Patients taking the following medications were excluded: * α-blockers * beta-blockers * calcium channel blockers * 5-alpha reductase inhibitors * PDE5 inhibitors * anticholinergics * nitrates * Patients with cardiac issues were excluded. * Patients with residual stone fragments after surgery were excluded. * Patients with multiple or bilateral ureteral stones were excluded. * Patients with long-term or bilateral stents requiring frequent changes were excluded. * Patients with interstitial cystitis were excluded. * Patients with chronic cystitis were excluded. * Patients with prostatitis were excluded. * Pregnant women were excluded. * Breastfeeding women were excluded. * Patients unavailable for follow-up were excluded.
Where this trial is running
Cairo, Abbasia
- Ain Shams University Hospital — Cairo, Abbasia, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Amr Mohammed Mounier, MSc
- Email: 160022@med.asu.edu.eg
- Phone: +201111984645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.