Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones

NCT05789732 | Completed

• 1 other identifier: Rc 22-3-2023
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the efficacy of silodosin, tadalafil versus silodosin plus tadalafil as Medical Expulsive Therapy (MET) for lower ureteric stones.

Conditions

Lower Ureteric Stones; Medical Expulsive Therapy; Tadalafil; Silodosin

Outcome Measures

Primary Outcomes (1)

• Stone expulsion rate

  Stone expulsion rate will be recorded

  Intraoperatively

Secondary Outcomes (2)

• Stone expulsion time

  Intraoperatively

• Amount of analgesia used

  Intraoperatively

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

Patients in this group will receive placebo treatment once daily.

Drug: Placebo

Silodosin group

EXPERIMENTAL

Patients will receive Silodosin 8 mg once daily.

Drug: Silodosin

Tadalafil group

EXPERIMENTAL

Patients will receive Tadalafil 5 mg once daily.

Drug: Tadalafil

Silodosin and Tadalafil

EXPERIMENTAL

Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.

Drug: Silodosin and Tadalafil

Interventions

Placebo DRUG

Patients will receive placebo treatment once daily.

Placebo group

Silodosin DRUG

Patients will receive Silodosin 8 mg once daily.

Silodosin group

Tadalafil DRUG

Patients will receive Tadalafil 5 mg once daily.

Tadalafil group

Silodosin and Tadalafil DRUG

Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.

Silodosin and Tadalafil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged \>18 years old.
• Both sexes.
• Diagnosed with lower ureteric stone from 5mm to 10mm in size.

You may not qualify if:

• Patients with multiple or bilateral ureteric stones
• single kidney or impairment of renal function
• Urinary tract infection (UTI)
• Marked hydronephrosis
• Patients presenting with severe intractable pain and requiring emergency intervention
• Any urologic anomalies or history of ureteral surgery
• Pregnancy
• Pediatric populations
• Ischemic heart disease
• Congestive cardiac failure
• Complicated hypertension
• Patients on concomitant treatment with nitrates or calcium channel blockers.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Egypt

Location

MeSH Terms

Interventions

silodosin; Tadalafil

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: March 30, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)