NCT07562282 Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg
| NCT ID | NCT07562282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-12-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ureteral stenting is a common urological procedure performed to relieve obstruction and facilitate urinary drainage. Despite its effectiveness, stent-related symptoms (SRS) such as dysuria, frequency, urgency, flank pain, and sexual discomfort negatively affect patient quality of life. Pharmacological management with alpha-blockers such as Tamsulosin and phosphodiesterase-5 inhibitors (PDE5i) such as Tadalafil has shown promise in reducing SRS. While low-dose Tadalafil (2.5 mg) has not been explored, its comparative effectiveness against the standard 5 mg dose when combined with Tamsulosin remains under-researched. This study aims to evaluate the difference in reduction of SRS between Tamsulosin with Tadalafil in standard and half dosage.
Eligibility 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.
Contact & Investigator
Waleed Mousa, Professor
STUDY DIRECTOR
Assistant Professor of Urology Department of Urology Ain Shams University
Frequently Asked Questions
Who can join the NCT07562282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 71 Years, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07562282 currently recruiting?
Yes, NCT07562282 is actively recruiting participants. Contact the research team at 160022@med.asu.edu.eg for enrollment information.
Where is the NCT07562282 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07562282 clinical trial?
NCT07562282 is sponsored by Ain Shams University. The principal investigator is Waleed Mousa, Professor at Assistant Professor of Urology Department of Urology Ain Shams University. The trial plans to enroll 140 participants.
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