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

NCT ID: NCT07206706

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-12-28

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.

Conditions

Management of Ureteric Stent Related LUTS and Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

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 Type: EXPERIMENTAL

Tadalafil 5Mg Tab

Intervention Type: DRUG

PDE5 inhibitor

Darifenacin 7.5 MG

Intervention Type: DRUG

anti muscarinic

Group 2

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 Type: EXPERIMENTAL

Tadalafil 5Mg Tab

Intervention Type: DRUG

PDE5 inhibitor

Darifenacin 7.5 MG

Intervention Type: DRUG

anti muscarinic

Interventions

Tadalafil 5Mg Tab

PDE5 inhibitor

Intervention Type: DRUG

Darifenacin 7.5 MG

anti muscarinic

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

hossam M elawady, MD

Role: PRINCIPAL_INVESTIGATOR

urology department, Ain shams university

Locations

Ain Shams University Hospita

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FMASU MS221/2022

Identifier Type: -

Identifier Source: org_study_id