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NCT Number: NCT07206706

Efficacy and Tolerability of Tadalafil Versus Darifenacin in Management of Ureteric Stent-Related LUTS

This randomized, crossover clinical trial evaluated the efficacy and safety of tadalafil compared with darifenacin in managing lower urinary tract symptoms (LUTS) and pain related to indwelling ureteric stents. A total of 150 patients who underwent ureteric stent insertion after endoscopic treatment of ureteric stones were enrolled. Patients were randomized into two groups: Group 1 received tadalafil 5 mg once daily for 3 weeks, followed by a 1-week washout, then darifenacin 7.5 mg once daily for 3 weeks. Group 2 received the reverse sequence.

The primary outcome was change in LUTS as measured by a shortened International Prostate Symptom Score (IPSS). The secondary outcome was stent-related pain measured by the Numeric Pain Rating Scale (NPRS). Drug safety and tolerability were also assessed.

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Key information

Conditions

Management of Ureteric Stent Related LUTS and Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ain Shams University Hospita

Cairo, Cairo Governorate, 1151, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age:18-40 years
  • Patient with ureteric stent size 6 Fr-26 cm post endoscopic procedure.

Exclusion criteria

  • Known prostatic patient with LUTS
  • Pregnant or lactating women
  • Recurrent urinary tract infection.
  • Neurological diseases.

Treatment and study plan

Tadalafil 5Mg Tab

Drug

PDE5 inhibitor

Darifenacin 7.5 MG

Drug

anti muscarinic

Primary outcomes

  1. change in stent related lower urinary tract symptoms (LUTS)

    Time frame: 3 weeks

    Change from baseline in stent-related symptoms, measured by a shortened International Prostate Symptom Score (IPSS), including incomplete emptying (Q1) and storage domain (Q2, Q4, Q7). The score was calculated (minimum 0 and maximum 20) according to patients' answers to the questions Higher scores indicate worse symptoms.

  2. Change in numerical Pain rating score (NPRS)

    Time frame: 3 weeks

    Change from baseline in ureteric stent-related pain, measured by the Numeric Pain Rating Scale (0 = no pain, 10 = worst pain).

Secondary outcomes

  1. Incidence of Adverse Events

    Time frame: Throughout the 7-week study period (3 weeks first drug, 1 week washout, 3 weeks second drug)

    Number and type of drug-related adverse events (e.g., dry mouth, constipation, headache, flushing, myalgia), recorded during each treatment phase.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy and Tolerability of Tadalafil 5mg Once Daily Versus Darifenacin for Ureteric Stent Related Symptoms

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2025
Registry last updated
Jan 16, 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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