RecruitingNot ApplicableNCT07562282

Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg

Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms


Sponsor

Ain Shams University

Enrollment

140 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 71 Years

Inclusion Criteria1

  • \- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal.

Exclusion Criteria28

  • 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
  • -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.

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Interventions

DRUGTamsulosin

Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.


Locations(1)

Ain Shams University Hospital

Cairo, Abbasia, Egypt

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NCT07562282


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