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NCT Number: NCT07562282

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

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.

Recruiting

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Key information

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospital

Cairo, Abbasia, Egypt

Location status: Recruiting

Location contact

Hisham Arafa, Lecturer

CONTACT

[email protected]

+201001921334

About this study

Ureteral stents are commonly used for temporary drainage in various urological procedures. Despite their usefulness, they are frequently associated with bothersome symptoms collectively termed as "stent-related symptoms" (SRS),These symptoms include flank pain, lower urinary tract symptoms (LUTS), hematuria, dysuria, urgency, frequency, and sexual dysfunction.

The exact pathophysiology of SRS is multifactorial, involving local irritation, vesicoureteral reflux, and smooth muscle spasm.

Various pharmacological agents have been studied to alleviate these symptoms, with alpha-blockers and PDE-5 inhibitors showing promising results .

Tamsulosin, a selective al-blocker, reduces bladder neck and distal ureteral smooth muscle tone, alleviating irritative urinary symptoms.

Tadalafil, a PDE-5 inhibitor, has been shown to improve LUTS through its smooth muscle relaxation and increased perfusion effects. While both have been studied individually and in combination, the optimal dose of Tadalafil in combination therapy is yet to be clearly established

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tamsulosin

Drug

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.

Other names: Tadalafil

Primary outcomes

  1. Evaluation of Ureteral Stent Symptoms

    Time frame: 4 weeks

    Evaluation of Ureteral Stent Symptoms postoperatively using Questionnaire (USSQ) score after treatment (from 1 to 5) as: 1 is best relief of symptoms but 5 is worsen relief of symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Amr Mohammed Mounier, MSc

CONTACT

[email protected]

+201111984645

Waleed Mousa, Professor

CONTACT

[email protected]

+201067628771

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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