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

NCT07206706 | Completed Phase 1 DMC

• 1 other identifier: FMASU MS221/2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• change in stent related lower urinary tract symptoms (LUTS)

  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.

  3 weeks

• Change in numerical Pain rating score (NPRS)

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

  3 weeks

Secondary Outcomes (1)

• Incidence of Adverse Events

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

Study Arms (2)

Group 1

EXPERIMENTAL

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

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

Group 2

EXPERIMENTAL

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

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

Interventions

Tadalafil 5Mg Tab DRUG

PDE5 inhibitor

Group 1; Group 2

Darifenacin 7.5 MG DRUG

anti muscarinic

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospita

Cairo, Cairo Governorate, 1151, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Tadalafil; darifenacin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• hossam M elawady, MD

  urology department, Ain shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: May 1, 2022
• Primary Completion: December 14, 2022
• Study Completion: December 28, 2022
• Last Updated: January 16, 2026

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)