Tamsulosin 0.4 mg with Tadalafil 5 mg versus 2.5 mg to reduce symptoms from ureteral stents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.