Efficacy and Tolerability of Tadalafil Versus Darifenacin in Management of Ureteric Stent-Related LUTS: Results From a Randomized Crossover Trial

Not Applicable

Completed

• Conditions: Management of Ureteric Stent Related LUTS and Pain
• Interventions: Drug: Tadalafil 5Mg Tab; Drug: Darifenacin 7.5 MG

• Registration Number: NCT07206706
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-05-01
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-28
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

1. Known prostatic patient with LUTS
2. Pregnant or lactating women
3. Recurrent urinary tract infection.
4. Neurological diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Tadalafil 5Mg Tab	in the 1st phase Group 1 received Tadalafil 5 mg tab once daily orally and switched to Darifenacin 7.5 mg once daily orally in the 2nd phase
Group 1	Darifenacin 7.5 MG	in the 1st phase Group 1 received Tadalafil 5 mg tab once daily orally and switched to Darifenacin 7.5 mg once daily orally in the 2nd phase
Group 2	Tadalafil 5Mg Tab	in the 1st phase: group 2 received darifenacin 7.5 mg once daily orally and switched to tadalafil 5 mg once daily orally in the 2nd phase of the study
Group 2	Darifenacin 7.5 MG	in the 1st phase: group 2 received darifenacin 7.5 mg once daily orally and switched to tadalafil 5 mg once daily orally in the 2nd phase of the study

Primary Outcome Measures

Name	Time	Method
change in stent related LUTS	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). Higher scores indicate worse symptoms.
Change in Pain Score (NPRS)	3 weeks	Change from baseline in ureteric stent-related pain, measured by the Numeric Pain Rating Scale (0 = no pain, 10 = worst pain).

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	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.

Trial Locations

Locations (1)

Ain Shams University Hospita; 🇪🇬 Cairo, Cairo Governorate, Egypt