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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07206706

Enrollment

150

Registered

2025-10-03

Start date

2022-05-01

Completion date

2022-12-28

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of Ureteric Stent Related LUTS and Pain

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.

Interventions

DRUGTadalafil 5Mg Tab

PDE5 inhibitor

DRUGDarifenacin 7.5 MG

anti muscarinic

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
change in stent related lower urinary tract symptoms (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). The score was calculated (minimum 0 and maximum 20) according to patients' answers to the questions Higher scores indicate worse symptoms.
Change in numerical Pain rating 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

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026