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

Ain Shams University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Management of Ureteric Stent Related LUTS and Pain

Treatments: Drug: Darifenacin 7.5 MG; Drug: Tadalafil 5Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT07206706

FMASU MS221/2022

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Darifenacin 7.5 MG

Drug: Tadalafil 5Mg Tab

Group 2

Experimental group

Description:

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

Treatment:

Drug: Darifenacin 7.5 MG

Drug: Tadalafil 5Mg Tab